Pre-market authorization schemes
8 important questions on Pre-market authorization schemes
Recognize situations in which market authorizations schemes apply?
- Genetically modified organisms
- Novel foods
- Additives, enzymes, flavoring, extraction solvents
- 'Nutrition and Health claim'
What is relationship between schemes and precautionary principle?
by treating them as dangerous unless and until
businesses do the scientific work necessary to demonstrate that they are safe.
What are two Authorization procedures?
- General: 'positive list', made by legislator; companies can apply for inclusion in the list; will be generally valid for everybody.
- Individual: individual companies apply with specific products, their application will be examined, and they are responsible
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What is effect of Pre-market approval?
- One-door-one-key
- EU-wide authorization
- environment and food safety risk assessment
- Cultivation and/or food and feed use in one go
What is the effect of GMO authorization?
- Authorizations are valid throughout the EU and may be for
- Cultivation and/or marketing of food and feed and derived products.
Acceptation on cultivation and Food and feed is on not the same acceptance.
What is the union list and when to get on list?
- Inclusion by European Commission
- Criteria:
- The food does not, on basis of the scientific evidence available, pose a safety risk to human health
- Does not mislead consumer
- Not nutritionally disadvantageous
- Application by business
- Safety assessment by EFSA
What is new under the new novel food regulation?
- Authorization exclusive for 5 years, is based on
- Recently developed scientific evidence or data
- Exclusive right of use
What are objective of the new Novel food regulation?
- Ensure food safety
- Functioning of the internal market
- Support innovation
- Streamline procedure
- clarify definition
- no substantial changes
- Simplified procedure for traditional foods from 3rd countries.
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