Lecture 7: before placing on the market

Question 1

when is pre-market authorization needed?

Answer 1

1. novel foods
2. food improvement agent packages
3. genetically modified organisms

Question 2

who is responsible for deciding to place something on the market?

Answer 2

1. ex ante: self assessment by FBO (also for non pre-market authorization)
2. ex post: official controls and alerts
   - precautionary principle: dangerous until business do scientific work to see if it’s safe

Question 3

which novel foods are under the union positive list

Answer 3

• don’t pose risk to humans helaht
• don’t mislead average consumer
• not nutritionally disaventageous

Question 4

how does the authorization work?

Answer 4

1. authorization (art 10-12)
   - need to provide recent science
   - can get data protection: exclusive for 5 years
2. simplified registration for traditional food
   - if no objection –> added to the list
   - if objection –> still need the authorization

Question 5

authorization for food improvement agent package

Answer 5

1. sent application to commission
2. if liable, asl efta for opinion (within 9 months)
3. commission submits draft regulation

Question 6

authorization for food improvement agent package

Answer 6

1. pre-market approval needed
   - EU wide authorization:

apply in MS –> risk assessment MS –> option EFSA –> go to EC –> appeal comittee