Food and Drink Innovation Network Daventry June 20071 Regulatory Aspects of Foods and Ingredients for Weight Management Neville Craddock Neville Craddock

Food and Drink Innovation Network Daventry June 2007 1

Regulatory Aspects of Foods and

Ingredients for Weight

Management

Neville Craddock

Neville Craddock Associates

Bletchingley, Surrey, UK


Presentation Overview

EU Health and Nutrition Claims Regulation

Requirements

Uncertainties

Specific requirements in relation to weight management

EU Novel Foods Regulation

Recap of current requirements

Possible revisions


“THE EU HEALTH CLAIMS REGULATION”

Regulation 1924 / 2006 of the European Parliament and of

the Council on Nutrition and Health Claims made on Foods

Corrected version:

OJ L 12, 18.1.2007, pp 3-18


Current EU Legislation on Health Claims

Legislation already in place:

Labelling Directive 2000 / 13

Medicines Directives 2001 / 83 and 2004 / 27

Misleading Advertising Directive 85 / 450 (as amended)

Directive 89 / 398 (Foods for Particular Nutritional Uses)

General Food Law Regulation 178 / 2002

European Court Judgements

Did we really need more?

Probably not - but nevertheless it’s coming!


DIRECTIVE 2000 / 13 - Article 2.1(b) The labelling, presentation and advertising of a food “must not

attribute … the property of preventing, treating or curing a human

disease, or refer to such properties.”

Labelling: “… words, particulars, trade marks, brand name, pictorial

matter or symbol placed on any packaging, document, notice, label, ring

or collar accompanying or referring to the food.”

Presentation: “…shape, appearance or packaging, packaging materials

used, way in which they are arranged and setting in which they are

displayed.”

Applies equally to explicit and implied claims

UK forbids any “tonic” claims

Arguably does not prevent “health maintenance” claims

But “disease risk reduction” has been a very grey area!


EU Claims Regulation – General Principles

Only claims that comply with the Regulation will be permitted

Claims must be supported by generally-accepted scientific evidence

capable of justification by operator

Product must contain ‘significant’ quantity of beneficial substance, or

reduction of ‘harmful’ substance, and able to deliver claimed effect

in quantity of food “reasonably expected to be consumed”

substance must be biologically available

Refers to food “ready for consumption” (c.f. ‘to be delivered’ earlier?)

N.B. Cannot include other foods in claims justification


EU CLAIMS REGULATION - Key Definitions

“Claim”: any non-mandatory message or representation (including pictorial,

graphic or symbolic) that states, suggests or implies a food has

particular characteristics.

“Health Claim”: any “claim” that states, suggests or implies relationship

between a food category, a food or one of its constituents and health.

“Reduction of disease risk claim”: any “health claim” that … consumption

of a food category, a food or one of its constituents significantly reduces a

risk factor in the development of a human disease.


EU CLAIMS REGULATION - Key Definitions

“Nutrition claim”: … any “claim” that a food has particular

beneficial nutrition properties due to

energy it does / does not provide (including reduced / increased)

“nutrients” or “other substances” it contains / contains in reduced

or increased proportions / does not contain.

“Nutrient”: protein, carbohydrate, fat, fibre, sodium, vitamins and

minerals in Annex to Directive 90/496 and their components.

“Other substance”: substance other than a “nutrient” that has a

nutritional or physiological effect.


“Health” Claims

All subject to prior authorisation (specific or generic)

Label (presentation or advertising) must include statements / advice

importance of ‘varied and balanced diet and healthy lifestyle’

quantity of food and pattern of consumption to achieve effect

if appropriate, persons who should avoid the food

appropriate warning, for products likely to present a health risk if

consumed to excess

Guidelines may be adopted “where appropriate”


Generally-accepted “Health” ClaimsPrior authorisation will not be required for claims describing

role of nutrient etc in growth, development or normal functions

psychological and behavioural functions

slimming, weight control

reduction in sense of hunger or increase in satiety

reduction in available energy from the diet

Provided they are

based on generally-accepted scientific evidence

well-understood by an “average consumer”

included on ‘Community list’ 31st January 2008 - Member States to provide Commission with list

31st January 2010 - Community list, after consulting EFSA, permitted claims

Complex transitional provisions will apply


“Disease Risk Reduction” Claims

Will be permitted following formal authorisation

Label must also state

the disease to which claim refers has multiple risk factors

altering one of these may / may not have a beneficial effect

Will appear on the public “Register”


“Nutrition” and “Comparative” Claims

NUTRITION CLAIMS (e.g. “rich” “low” “free”)

Only permitted if listed in, and comply with, detailed conditions in

Annex

COMPARATIVE CLAIMS (e.g. “chalk versus cheese”)

Comparison only between foods of same category, taking into account

a range of foods in category

Difference in quantity of nutrient and / or energy must be stated

Comparison must relate to same quantity of food

Comparison against range of foods whose composition does not allow

a claim, including other brands


EU Health and Nutrition Claims

Ongoing Issues


EFSA Scientific Substantiation of Claims

SCIENTIFIC AND TECHNICAL GUIDANCE FOR THE

PREPARATION AND PRESENTATION OF THE APPLICATION

FOR AUTHORISATION OF A HEALTH CLAIM

Draft Opinion of the Scientific Panel on Dietetic Products,

Nutrition and Allergies

Published May – closed 17th June 2007


EU CLAIMS REGULATION – Ongoing Issues

"nutrient profiles" (Article 4.1)

how will they be determined?

what will they comprise?

industry wishes to add several nutrient parameters to Annex

complexity of various transitional periods


Miscellaneous Issues

Trade Marks, Brand Names or Fancy Names perceived as a claim

may continue without new authorisation but must carry ‘compliant claim’

Generic, traditional descriptors (“digestive”): derogations possible

business application to MS to forward to EC (SCFCAH procedure)

EC to publish rules to enable “transparency and reasonable time”

“Non-beneficial” claims / schemes are not covered (recital 6)

believed aimed at FSA “traffic lights” and similar national schemes

‘Yellow fat spreads’ Regulation still applies, but will be adapted

National / EU alcohol abuse messages are excluded

Liquid food supplements with >1.2% alcohol are not ‘beverages’


EU HEALTH CLAIMS – Outstanding Issues

Traditional generic denominations: need to clarify underlying procedure

Broad scope includes “any commercial communication” incl. websites -

enforcement against non-EU operators / TVWF etc?

A lot of work is needed, with the input of all relevant stakeholders

(nutrient profiles, Art. 13 list, extension of Annex)

Need for numerous “implementing rules and technical guidelines”

non-prepacked foods

procedure for traditional denominations

derogations for certain nutrients - Art. 3 (d)

specific conditions for labelling and “warnings” - Art. 10

presentation and preparation of applications - Art. 15 (4) and (5)


EU HEALTH CLAIMS – Outstanding Issues

No legal definition of “children”

What is “generally-accepted” scientific evidence?

What is “well-understood” by average consumer?

Uncertainty of critical concepts

“normal” body functions

psychological and behavioural functions (intelligence / concentration?)

Is “calorie burning” within “slimming, weight control” scope?

Transitional periods for “child development and health” claims

Clarification of possible overlapping transition periods

Interpretation of unclear terms and provisions to obtain legal

certainty for operators and enforcement bodies


What is an “Average Consumer”?

ECJ rulings consistently describe “average consumer” as:

“reasonably well-informed, reasonably observant and circumspect”

Claims Regulation: "It is appropriate to protect all consumers from misleading

claims. However, the ECJ has found it necessary … since [the Misleading

Advertising Directive] to examine the effect on a notional, typical consumer. In line

with … proportionality, and to enable the effective application of the protective

measures contained in it, this Regulation takes as a benchmark the average

consumer as interpreted by the ECJ, taking into account social, cultural and

linguistic factors but makes provision to prevent the exploitation of consumers

whose characteristics make them particularly vulnerable to misleading claims".

Labelling Directive: “… could mislead the purchaser to a material degree”

Can Claims Regulation go beyond ECJ?


Energy - Restricted Diets

for

Weight Reduction

Directive 1996 / 8

and

Regulation 1924 / 2006


Foods for Particular Nutrition Uses

“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.”

Medicinal claims prohibition applies to all foods including PARNUTS

foods

PARNUTS foods must be notified to FSA

Council Directive 89/398/EEC


Foods for Weight - Reduction Diets

Foods for use in energy-restricted diets for weight reduction are

specially formulated foods which, when used as instructed by the

manufacturer, replace the whole or part of the total daily diet

Two categories: products presented as

replacement for the whole of the daily diet

• All individual components must be in the same package

• 'Total diet replacement for weight control`

replacement for one or more meals of the daily diet

• 'Meal replacement for weight control`

All must meet compositional criteria specified in Annex 1


Labelling of “Slimming” Foods (1)

In addition to requirements of Directive 2000/13 must declare

available energy (kJ and kcal), proteins, carbohydrates and fat

per specified quantity of product ready for use as recommended

average quantity of each mineral and vitamin specified in annex 5.1

per specified quantity of product ready for use as recommended

in addition, meal replacements must declare %RDAs

appropriate preparation instructions and statement as to importance

of following those instructions


Labelling of “Slimming” Foods (2)

In addition to requirements of Directive 2000/13 must declare

laxative effect statement if product provides > 20g per day polyols

importance of maintaining an adequate daily fluid intake

whole daily diet replacements must state that product

provides adequate amounts of all essential nutrients for the day

should not be used for more than three weeks without medical

advice

meal replacements must state that product

is useful for the intended use

• only as part of an energy restricted diet

• other foods should be a necessary part of such diet



Directive 96/8:

labelling, advertising and presentation must not refer

to the rate or amount of weight loss which may result

to a reduction in sense of hunger or increase in sense of satiety

Regulation 1924/2006, Article 13(1)(c)

now allows health claims describing or referring in particular to a

reduction in the sense of hunger or an increase in the sense of

satiety under specified conditions



Directive 96/8, Article 5, paragraph 3 is replaced by the following:

‘3. The labelling, advertising and presentation of the products

concerned shall not make any reference to the rate or amount of

weight loss which may result from their use.’

Reference may in future be made to reduction in sense of hunger or

increase in sense of satiety

Member States must apply these provisions from 1 July 2007


NOVEL FOODS

EU Regulation 258 / 97


Came into force 15 May 1997

EU-wide mandatory pre-market approval system for “novel” foods

Safety-based assessment

Applies in all (27) Member States

Recommendation 97 / 618 describes scientific aspects for assessments

Since April 2004 GM foods have a separate legislative route

EC Novel Foods Regulation 258/97


EU Regulation 258/97 - Scope

… not used for human consumption to a significant degree within EC

(before 15th May 1997) and which …

… has new or intentionally modified primary molecular structure

… consists of or isolated from micro-organisms, fungi or algae

… consists of, or isolated from, plants and ingredients isolated from

animals, except for foods obtained by traditional propagating or

breeding practices and having a history of safe food use

[… to which has been applied a (novel) production process … (which) gives rise

to significant changes in composition or structure which affect nutritional value,

metabolism or level of undesirable substances]


Categories – some examples

foods with a new / modified primary molecular structure

(e.g. SALATRIM, Tagatose, Isomaltulose)

foods from micro-organisms / fungi / algae

(e.g. fungal lycopene, DHA, Glucosamine)

foods from plants / animals obtained by traditional practices

(e.g. Phytosterols, Nangai nuts, Noni, Chia, Baobab)

new food processing methods that change composition

(e.g. HPP of fruit preparations, new enzymic process)


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

(General Food Safety Law Regulation 178/2002 applies)

Products with clearly defined, separate safety assessment route

Additives

Flavourings

Extraction solvents

Providing the level of safety is equivalent to that delivered by 258/07

Processing aids

Medicines (e.g. UK MHRA)

n.b. they routinely check!!


Supplements and Additives - Prior Use

Dietary supplement use prior to 15th May is NOT indicative of significant

use as a food ingredient

This view was ‘formalised’ by MS at SCFCAH* in February 2005

Similar view applies if history of prior use only as a food additive

Number of examples

Phosphated distarch phosphate - glucosamine

* Standing Committee on the Food Chain and Animal Health


EU Novel Food Regulation 258/97

Safety-Driven

Novel Foods / Ingredients must not

present a danger to the consumer

mislead the consumer

differ from those they are intended to replace such that their normal

consumption would be nutritionally disadvantageous

Safety Assessment or Notification

Via one of two procedures, depending on degree of "novelty"

Full Assessment, or

“Notification” - if “substantially equivalent” to existing product


So …

where are the problems …

and

what needs to be done?


Regulation 258/97 – Issues and Problem Areas

Imprecise definitions – clarity needed for practical application:

“Significant consumption” - numerical and / or nutritional?

“Substantially Equivalent” – ambiguity: neither term defined

• “reasonably similar” or “virtually identical”?

‘Traditional’ foods

History of Safe Food Use

Balance between “customary knowledge” and “modern science”

WTO compatibility

Novel Processes

Generic versus Company authorisations

Cost and Timescale of applications

“Arbitrary” cut-off date of 15th May 1997


NFR Review - The Biggest Hurdle?

“History of safe food use” for ‘exotic foods’ can be subjective:

assumes lengthy history of food use in a particular country or culture

sufficient to show that any risks are probably acceptable

but … impossible to establish certainty of “safety” without extensive

scientific and toxicological studies

Goal should be “acceptable (or proportionate) level of risk”

“History of use, with reasonable certainty of no harm" better reflects

that “no risk” is unachievable, but minimized risk is possible

Long history of use by indigenous populations is evidence of safety

dependent on the management of known risks

discontinued if found to be disproportionately unsafe


Imprecise Definitions – Adverse Consequences

Precise definitions and consistent application of concepts are needed

“Significant”: is qualitative and subjective

“Consumption to significant degree”:

pre-1997 imports - proof difficult …

excluding pharmacies?!

historic, local production and/or traditional domestic consumption

use and sales in all EU-27

Does refusal to accept full range of availability of the products, and then

using “lack of consumption” as argument to block 3rd country imports

constitute non-tariff barrier?


Revision of Regulation 258/97 – current thinking

Retain 15 May 1997 cut-off, but

public comment before assessment to ensure products are novel?

Centralised assessment and authorisation procedure

“Substantial equivalence” & Notification procedure may be dropped

possibility of alternative approach for 'me too' applications?

Different categories could be dropped (food defined under 178/2002)

novel processes and non-traditional breeding methods may stay

More emphasis on history of (safe) food use for traditional (non-EU)

foods rather than usual suite of safety studies


Revision of Regulation 258/97 – current thinking

Greater clarity of terms and concepts, e.g. guidelines to accompany legislation

“traditional foods” … “consumption to a significant degree”

Flexibility for simultaneous applications under 'Claims' and 'Supplements‘ rules

Usual consultations etc for comment

Aspects that would need to be addressed:

Proportionate balance of “customary knowledge” and “modern science” to produce

“scientific evidence” in safety dossiers for ‘traditional foods’

How, where and by whom, can valid “scientific evidence” be produced:

e.g. by applicant industry / national authority; university / research institutes; third

country / EU?

More cost-effective administrative and scientific assessment process

economically and technically feasible; learn from others

Feasibility of generic applications / authorisations?


Thank you for your attention,

ladies and gentlemen.

Any comments or questions?


Neville Craddock AssociatesTun House

28 High Street BletchingleySurrey UK

[email protected]

Tel: +44 (0) 1883 740 553

Mob: +44 (0) 7802 641 081

mailto:[email protected]

Documents

Food and Drink Innovation Network Daventry June 20071 Regulatory Aspects of Foods and Ingredients for Weight Management Neville Craddock Neville Craddock