background image
HOW TO REGULATE ?
REGULATIONS = A DYNAMIC TOOL
EU Directives
EU Directives
(1935/2004 72/2002)
(1935/2004 72/2002)
Decisions of EU Council
Decisions of EU Council
EFSA
EFSA
= European Food Safety Agency
= European Food Safety Agency
Federal Food, Drug and Cosmetic Act (FFDCA)
Federal Food, Drug and Cosmetic Act (FFDCA)
Fair Packaging and Labelling Act)
Fair Packaging and Labelling Act)
REFERENCES
REGULATED
FOOD CONTACT
FOOD CONTACT
MATERIALS = FCM
MATERIALS = FCM
FOOD, ADDITIVES IN CONTACT
FOOD, ADDITIVES IN CONTACT
WITH FOOD
WITH FOOD
PRINCIPLES
Composition, positive list of authorized substances
Overall migration (<60 mg/kg), specific migration (ppb based
on toxicological testing), residual content
Fast tests based on worst case paradigm: food stimulants,
higher temperature
Migration Modeling authorized for certain plastic materials
LIMITATIONS
contradictions: sometimes too restrictive, non applicable
in
complex
cases
(reactive
migrants,
aging,
active/multilayer materials) adverse (economic) risk
will change in next 10 years towards the USA system
(for now, just amended) by including cumulative exposure
assessment.
Additive (direct/indirect) = active substance (application
related: process, use, food...)
Packaging is regulated only if a migration occurs
Toxicology appraisal of any chemicals (via FDA full
petition/list of generally recognized as safe substance)
Exposure assessment (extrapolation of consumption data
migration data )
threshold (0.5 ppb) authorized for substances that are
recognized as non-carcinogenic
highly depend of available knowledge (no direct
application of precaution principle)
rough approximation of impact factors
INERTIA PRINCIPLE
43 member states
43 member states