© nino binns 2009fdin 8 th july 20091 safe claims for healthy middle years nino binns bsc phd nmb...

FDIN 8th July 2009 1 © Nino Binns 2009

Safe Claims for Healthy Middle Years

Nino Binns BSc PhD

NMB ConsultingIreland


Outline

• What type of claims are being used now and can we still use them?

• The latest on the regulations that control nutrition and health claims

• How to get new health claims approved (not easy!)

• Other regulations to watch out for


Regulatory Considerations

Formulation

CommunicationLabelling

Packaging



FormulationAdditives

Novel foodsVitamins and minerals

BotanicalsNutrient profiles


Packaging



Formulation


Packaging



Formulation

Communication

LabellingFood InformationNutrition labelling

Front of pack

Packaging



Formulation

CommunicationNutrition claimsHealth claims

Commercial communicationsLabelling

Packaging

Nutrition and Health Claims Regulation 1924/2006

AnnexContent

Comparative

Nutrition Nutrition ClaimsClaims

Health ClaimsHealth Claims

(a) Function

(b) Cognitive

(c) Slimming

Reduction of disease risk;

children’s health/devlpt

Based on new science

or proprietary

data

Art 13.1 Health claims

WHAT THE PRODUCT DOESWHAT THE PRODUCT DOES

WHAT WHAT THE THE

PRODUCT PRODUCT CONTAINCONTAIN

SS


Nutrient profiles

Labelling

Consumer Understanding

Art 14 Health claims


Nutrition Claims

• With B vitamins• Rich in calcium• Low fat/saturates• Rich in fibre• Contains isoflavones• Contains omega 3• Cholesterol free


WHAT WHAT THE THE


SSAnnex

Jan 2

010Now

CONTAINS [NAME OF THE NUTRIENT OR OTHER SUBSTANCE]


Proposed New Nutrition Claims

• Source of omega-3 fatty acids• High omega-3 fatty acids• High mono unsaturated fat • High poly unsaturated fat• High unsaturated fat


Nutrition Claims


WHAT WHAT THE THE


SSAnnex

• Contains antioxidants• Contains probiotics

= Health Claims


Health Claims

• List of >4000 claims being evaluated by EFSA

• List supposed to be adoted by Jan 2010 but delay expected

• Latest info that EFSA opinions not till second half 2010

• Legal use claims until list published (unless Article 13.5/14 dossier rejected)

• Dossiers being evaluated by EFSA

• Decisions on Art 14 (not 13.5) voted in Standing Committee (Member States)

• EFSA has set very high science hurdle


Art 13.5 New/propclaims

Art 14 DRR/child

claims


Which claims will be approved?


EFSA OpinionsApprox Status 25 June 2009

ReceivedWithdraw

nPublished

"Approved"

Children 215* 15 43 9 (11)

Disease 38 1 8 3

Art 13.5 20 6 9 1

*approx 145 not completed registration


Art 13

• Bone health – calcium, vitamin D

• Fibre - transit time• Probiotics - transit time• Satiety • LC omega 3 -

heart/vascular health• WSTC - normal platelet

aggregation (approved)

• B vitamins - mental health related

• Weight control (rate and amount prohibited)

• Isoflavones – menopause

• Glycaemic index/load• Beauty

Risky?A safe bet?


• Phytostanol/sterol - LDL cholesterol reduction (approved)

• Oats/ soya – LDL-C• Sodium - blood

pressure• Tri-peptide - blood

pressure

• Cancer related claims (not yet!)

• Osteoporosis

A safe bet?

Art 14

Risky?


What about these?

• Joint health– LC omega 3, zinc, boron – Chondroitin, glucosamine, MSM, isoflavones,

GLA, botanicals– Lot of evidence on “treatment” of “symptoms”

• Insulin sensitivity– Fibre, carbs, bread etc,; protein; Mg,Cr,Zn;

DHA/EPA, CLA; (pro) anthocyanidines; fenugreek, garlic, bilberry

• Fruits and vegetables– Based on observational studies


Approval of Article 13.5 and Article 14 claims


Reading Matter Regulations

• COMMISSION REGULATION 353/2008 -implementing rules for applications for approval of health claims per Article 15 of 1924/2006– Re-iteration of parts of Council

regulation and of EFSA technical guidance

– Sets the high standard for science into legally binding text


Reading Matter EFSA

• Detailed Guidance on dossiers plus the document templates on EFSA website:http://www.efsa.europa.eu/EFSA/efsa_locale-

1178620753812_1178623592471.htm

• Guidance is complicated– Read it carefully then read it again– Or find an expert!

• Read the EFSA opinions avidly


Key Elements of EFSA Assessment

• Characterisation• Relevance (benefit) to human

health• Substantiation of the claim• Proposed wording• Conditions of use


The First Consideration!Nutrient Profiles

• Nutrition claim - one profile may be exceeded –but must state food is “high in xxx”

• Health claim - must respect all profiles

• Sodium• Saturates

• Sugars

Apply 24 months following adoption


Thank you

Nino M Binns BSc PhDConsultant in Nutrition and Food

Regulation

[email protected]/fax: +353 41 983 4644

Proposed New Nutrition Claims• "SOURCE OF OMEGA-3 FATTY ACIDS• A claim that a food is a source in omega-3 fatty acids, and any claim likely to have the

same meaning for the consumer, may only be made where the product contains minimum 0,3g alpha-linolenic acid per 100g [and per 100kcal], or minimum 30mg of the sum eicosapentaenoic acid and docosahexaenoic acid per 100g [and per 100kcal].

• HIGH OMEGA-3 FATTY ACIDS• A claim that a food is high in omega-3 fatty acids, and any claim likely to have the same

meaning for the consumer, may only be made where product contains minimum 0,6g alpha-linolenic acid per 100g [and per 100kcal], or minimum 60mg of the sum eicosapentaenoic acid and docosahexaenoic acid per 100g [and per 100kcal].

• HIGH MONO UNSATURATED FAT • A claim that a food is high in monounsaturated fat, and any claim likely to have the same

meaning for the consumer, may only be made where at least 45% of the fatty acids present in the product derive from monounsaturated fat under the condition that monounsaturated fat provides more than 10% of energy of the product.

• HIGH POLY UNSATURATED FAT• A claim that a food is high in polyunsaturated fat, and any claim likely to have the same

meaning for the consumer, may only be made where at least 45% of the fatty acids present in the product derive from polyunsaturated fat under the condition that polyunsaturated fat provides more than 10% of energy of the product.

• HIGH UNSATURATED FAT• A claim that a food contains high amount of unsaturated fat and any claim likely to have

the same meaning for the consumer may only be made where the amount of unsaturated fat is 70% of the total fat content in the product under the condition that unsaturated fat provides more than 10% of energy of the product. "


Front of Pack Labelling

© nino binns 2009fdin 8 th july 20091 safe claims for healthy middle years nino binns bsc phd nmb...

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