Claims approval process

The EFSA process explained Frédéric René

EU regulation on health and nutrition claims

EU Regulation on nutrition and health claims

Claims approval

PO Q

Nutrient profiles

Claims Approval – Key Players + Process NDA Panel

European Parliament

Scientific claim evaluation

Member States

Consumer claim

European Commission

PO Q

Claims regulation: Scope

All nutrition and health claims which state, suggest or imply that a food has particular beneficial characteristics, including: any message or representation including pictorial, graphic or symbolic representation, brand and trade marks all commercial communication intended for final consumer: labeling, presentation or advertising of foods

Health claims definition Article

13

Article

14

« Functional claims » Growth, development & functions of the body Psychological and behavioural functions Slimming, weight control, reduction in the sense of hunger, increase in the sense of satiety

Article

13.3

“Generic claims”

Article

.5 13

“Specific claims” Claims based on new science or for which data protection was requested

1. Disease risk reduction claims

2. Children’s claims

Claim that states, suggests or implies that the consumption of a food significantly reduces a risk factor in the development of a human disease.

Claims solely referring to the development and health of children and used on products intended exclusively to children

Claims approval process Article

.3 13 Claims list published – EFSA to provide opinions Opinions submitted to Commission  draft Regulation

Commission draft Regulation submitted to Standing Committee for discussion/vote European Parliament and Council scrutiny

Publication in Official Journal

To be finalized in 2009

Claims approval process Article

.5 13

Article

14

EFSA to provide opinions on applications

30-day consultation period after opinion published Positive

Negative

Opinions submitted to Commission  draft Regulation of all claims (positive and negative)

EC consultation with MS

Commission draft Regulation submitted to Standing Committee for discussion/vote

EC decision

European Parliament and Council scrutiny

Publication in Official Journal