Making Claims in a Changing Regulatory

Environment Key Changes and Potential Impact

The Industry Perspective

Eva Hurt, Regulatory Affairs ManagerNestlé UK & Ireland

FDII Nutrition and Health Claims Summit17 January 2007

The Basics

The Regulation harmonises requirements on nutrition and health claims on food products across the 27 countries of the EU

Consumer and business advantage

Claims may not: Be false or misleading Refer to prevention, treatment or cure

of a disease

Scope of the Regulation

Scope Covers nutrition and health claims in foods and

food supplements Includes any claims made in Labelling, Advertising,

PR and on Websites Impact on trademarks and brands

Entry into Force - Application Transitional periods: 1-2-3-4-15… years A number of provisions apply from 1st July

2007

Nutrition and Health Claims

Scope of the Regulation: Nutrition Claims - What the product

contains- Nutrient content claims (e.g. low fat, high fibre,

high in calcium); Comparative (e.g. increased, reduced, light)

Health Claims – What the product does

- Well-established claims- Reduction of Disease risk Claims- Claims referring to children’s development and

health

Nutrition Claims

What the product contains (e.g. low sugar, source of protein, high calcium):

List of permitted nutrition claims in Annex Only claims on the list will be allowed (“positive

list”) Claims such as “X% fat free” prohibited What about claims such as….?

– Source of omega 3 (transitional measure)– Contains wholegrain (ingredient claim)– Contains antioxidants…

Nutrition claims are subject to nutrient profiles!

Comparative Claims

Comparative claims may only be made between foods of the same ‘category’– No more ”Half the vitamin C of an orange”– Still do not know what a ‘category’ will be

Comparative Claims may only be made with food which itself cannot make a claim: – What about “As much calcium in yogurt as in a glass of

milk”? or– As much Calcium in a soya drink as in a glass of milk

4 Types of Health Claims

What the product does1. Well-established Health Claims (Calcium

& strong bones, Vit B2 & release of energy from food, whole grain & heart health …)List of generic health claims (Art 13)

2. Health Claims based on newly developed science and/or protected data (Claims not on Article 13-list)“Accelerated” authorisation procedure (Art 18)

4 Types of Health Claims

3. Disease risk reduction claims (“X may help reduce the risk of developing diabetes”)Full authorisation procedure (Art 14)

4.Claims referring to children’s development & health (Benefit of Calcium and growing kids) Full authorisation procedure (Art 14)

Procedure: Health Claims art.13 Community List

Addition of claimsProcedure 18

Modification List by Commission or MSProcedure 25(2)

Adoption by Commission Community List E + 3 years

Consultation EFSA by Commission

Provision List by MS to CommissionE + 1 year

Full Application Procedure

Final decision

Submission Commission draft decision to Committee2 months

Public/applicant comments to Commission30 days

EFSA opinion to Commission, MS & applicant5 months (max. extension + 2 months

EFSA informs other MS& summary for public

MS acknowledges receipt & transfers application to EFSA14 days

Application sent to MST

Children’s claims

• Claims on children’s development and health

• No transitional period

• Full a priori authorisation

Discussion with Commission to lobby for– Amendment including reasonable transitional

period – Clarification of the procedure involved – more

proportionality

Nutrient Profiles

Will be developed within 2 years with regard to Fat/Saturated Fat/TFA/Sugar/Salt

Condition to make any type of Nutrition or Health claims (fully applicable 2011)

Exemptions:

– “Reduced” fat/sugar/salt is allowed (30% reduction)

– If one nutrient exceeds profile, nutrition claim can be made, but statement: “High content of salt”

Nutrition and Health Claims Regulation

Status

– Publication anticipated tomorrow 18th January To do list for industry:

– All new claims to be made in line with Regulation

– Assess impact on claims already on market

– Ensure adequate scientific basis for all claims

– Prepare/submit application dossiers, where necessary

Big(gest) concern: EFSA resources