Post on 14-Dec-2015
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
Food and Drink Innovation Network Daventry June 2007 2
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
Food and Drink Innovation Network Daventry June 2007 3
“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
Food and Drink Innovation Network Daventry June 2007 4
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!
Food and Drink Innovation Network Daventry June 2007 5
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!
Food and Drink Innovation Network Daventry June 2007 6
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
Food and Drink Innovation Network Daventry June 2007 7
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.
Food and Drink Innovation Network Daventry June 2007 8
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.
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“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”
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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
Food and Drink Innovation Network Daventry June 2007 11
“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”
Food and Drink Innovation Network Daventry June 2007 12
“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
Food and Drink Innovation Network Daventry June 2007 13
EU Health and Nutrition Claims
Ongoing Issues
Food and Drink Innovation Network Daventry June 2007 14
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
Food and Drink Innovation Network Daventry June 2007 15
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
Food and Drink Innovation Network Daventry June 2007 16
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’
Food and Drink Innovation Network Daventry June 2007 17
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)
Food and Drink Innovation Network Daventry June 2007 18
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
Food and Drink Innovation Network Daventry June 2007 19
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?
Food and Drink Innovation Network Daventry June 2007 20
Energy - Restricted Diets
for
Weight Reduction
Directive 1996 / 8
and
Regulation 1924 / 2006
Food and Drink Innovation Network Daventry June 2007 21
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
Food and Drink Innovation Network Daventry June 2007 22
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
Food and Drink Innovation Network Daventry June 2007 23
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
Food and Drink Innovation Network Daventry June 2007 24
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
Food and Drink Innovation Network Daventry June 2007 25
Foods for Weight - Reduction Diets
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
Food and Drink Innovation Network Daventry June 2007 26
Foods for Weight - Reduction Diets
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
Food and Drink Innovation Network Daventry June 2007 28
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
Food and Drink Innovation Network Daventry June 2007 29
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]
Food and Drink Innovation Network Daventry June 2007 30
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)
Food and Drink Innovation Network Daventry June 2007 31
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!!
Food and Drink Innovation Network Daventry June 2007 32
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
Food and Drink Innovation Network Daventry June 2007 33
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
Food and Drink Innovation Network Daventry June 2007 34
So …
where are the problems …
and
what needs to be done?
Food and Drink Innovation Network Daventry June 2007 35
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
Food and Drink Innovation Network Daventry June 2007 36
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
Food and Drink Innovation Network Daventry June 2007 37
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?
Food and Drink Innovation Network Daventry June 2007 38
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
Food and Drink Innovation Network Daventry June 2007 39
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?
Food and Drink Innovation Network Daventry June 2007 40
Thank you for your attention,
ladies and gentlemen.
Any comments or questions?
Food and Drink Innovation Network Daventry June 2007 41
Neville Craddock AssociatesTun House
28 High Street BletchingleySurrey UK
nevillecraddock@tunhouse28.fsnet.co.uk
Tel: +44 (0) 1883 740 553
Mob: +44 (0) 7802 641 081