Eva Hurt, Regulatory Affairs Manager Nestlé UK & Ireland FDII Nutrition and Health Claims Summit

1. Making Claims in a Changing Regulatory EnvironmentKey Changes and Potential ImpactThe Industry Perspective Eva Hurt, Regulatory Affairs Manager Nestlé UK & Ireland FDII Nutrition and Health Claims Summit 17 January 2007

2. 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

3. 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

4. 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

5. 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!

6. 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

7. 4 Types of Health Claims • What the product does 1. 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)

8. 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)

9. Procedure: Health Claims art.13 Community List

10. Full Application Procedure

11. 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

12. 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”

13. 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