Lecture 10 : Food packaging regulations Flashcards
US FDA Regulations
Regulations for Food Contact Materials (FCM) for FDA is regulated under Code of Federal Regulations (CFR) Title __, Parts __ to ___?
CFR Title 21, Part 174-186
US FDA Regulations
FDA’s GMP regulations for FCM is under which regulation?
CFR Title 21 Part 174.5
What is a positive list for food contact substances?
It is a list where only substances explicitly listed and approved for use in food contact materials are allowed
- can only use food contact substances listed in the positive list
The Positive List is mainly for FCS (Food Contact Substances) — i.e., the chemical ingredients used to make FCMs.
However, it plays a regulatory role in controlling which substances can be used in FCMs like plastics, adhesives, etc.
Note : FCS and FCM is NOT the same!
FDA Regulations
For Food Contact Substances (FCS), they can be used without seeking approval from FDA if they fall under which 5 categories? (apart from being in positive list)
- Approved indirect food additives
- GRAS for use in or on contact with food
- Substance whose use in contact with food is the subject of a prior sanction issued by FDA/USDA before 1958
- Substances under a threshold regulation exemption by FDA
- If substance is the subject of an effective Food Contact Notification (FCN) since Oct 1999
FDA Regulations
If a FCS does not fall under the 5 categories / not in positive list, it can undergo either 1 of 2 processes to get approved. What are these 2 processes?
- Food contact notification (FCN)
- Threshold of regulation process
FDA Regulations - Food Contact Notification, FCN
Scope of FCN : for new uses of FCS that are _____?
Food additives;;
i.e. the food contact substance (FCS) is used as an additive in food packaging, but not added to the food itself.
FDA Regulations - Food Contact Notification, FCN
Outline the steps on how the FCN works.
1) The supplier submits the FCN to FDA, with providing the required safety data of the FCS.
2) Review period (phase 2) : FDA has 120 days to review the FCN
3) If no objection is raised within 120 days, FDA will issue an effective date, and FCS can be used 120 days after the effective date.
4) If objection is raised (usually due to insufficient info)
a. Within 2 weeks of objection : suppliers can choose to withdraw from FCN
b. > 2 weeks of objection : the FCN will be deemed unacceptable if info is incomplete
5) After the objection, if suppliers provide enough info, they proceed to phase 2, and go through steps 2-3
FDA Regulations - Food Contact Notification, FCN
A FCN is “propietary”. Explain what this means.
FDA approval for the FCS to be used is exclusive to the manufacturer or supplier who submitted the notification.
- This means that other companies cannot rely on that specific FCN to use the same food contact substance for the same use. They would need to file their own FCN.
FDA Regulations - Food Contact Notification, FCN
What is the difference between FCN and Petition under FDA regulation?
FCN applies only to the specific manufacturer and substance; a petition grants a broader approval usable by all companies and is used when data is insufficient to prove the safety of the FCS or the use is widespread throughout the industry (but takes v long time, several years)
FDA regulations
One of the more significant / important guidelines for FCS in FDA regulations involves guideline for FCN for FCS in contact with infant forumula and/or human milk. What is the age range of infant that this guide covers, and what is the units for overall migration limit (OML)?
0-6 months old ;;
OML (overall migration limit) = mg/kg of food
(Check the 1-3 years old)
EU regulations : EFSA ( European Food Safety Authority)
What does Regulation (EC) 2023/2006 cover and its purpose?
All Food Contact Materials (FCM) must be manufactured in accordance with Good Manufacturing Processes (GMP).
EU regulations : EFSA ( European Food Safety Authority)
Regulation (EC) 1935/2004 : what is the main purpose and contents covered?
Regulation (EC) 1935/2004 establishes general principles for safety and inertness of FCM.
- FCM must not release harmful substances at levels harmful to human health (safety)
- FCM must not alter taste, odour, composition (quality) of a food in an unacceptable way (inertness)
EU regulations : EFSA ( European Food Safety Authority)
What are the important articles under the EU 1935/2004 covering regulations on food contact materials? [4]
1) Article 3 : General requirements of FCM
2) Article 5 : Specific measures for groups of materials / articles
- Authorised substances (FCS) must be from positive list
- Authroised FCS incoporated into active / intelligent packaging, and special conditions of use
- Purity standards of FCS
- Specific limits
- Overall limits
- Rules for collection of samples and methods of analysis
3) Article 15 : labelling
4) Article 17 : Traceability
EU regulations : EFSA ( European Food Safety Authority)
What does Regulation (EC) 10/2011 cover? [main definition, 2]
Specific rules for plastic materials intended to come into contact with food, including the
- positive list of authorized substances (FCS)
- migration limits (SML, OML).
EU regulations : EFSA ( European Food Safety Authority)
What are the EU rules for FCS (EC 1935/2004) that are also food additives or flavorings (e.g. under EC 1333/2008 or 1334/2008)?
The lower of the migration limits from the food additive / flavouring regulation or FCM regulation must be followed.
For example, if the migration limit under EC 1333/2008 (food additive) is lower than migration limit under EC 1935/2004 (FCM), the migration limit under 1333/2008 should be followed
What is the difference between specific migration limit and overall migration limit?
Specific migration limit : it is the maximum permitted amount of a specific substance migrating into food.
- Individual substance, considers specific toxilogical profile
Overall migration limit : Total amount of substances migrating from a food contact material into a food.
What are the units for specific migration limits for FDA and ESFA?
FDA : mg / kg of food
ESFA : mg / kg of food
What are the units for overall migration limits for FCM for FDA and ESFA?
US FDA : mg / kg of food
ESFA : 10 mg/dm² of food simulants (for plastic materials and articles) ;;
How is a migration test conducted for food packaging (e.g. using food simulant under ESFA)?
- Put food simulant into the plastic packaging under specific environmental conditions (humidity, temp)
- After a few days, run analytical tests (e.g. HPLC) to quantify the concentration of migrated substance into the food simulant (do analytical test on the food simulant or food itself)
What is meant by set off migration?
Unintended transfer of inks / coatings from the outer printed lauer to the inner food-contact surface due to stacking of packaging or rolling packaging into reels.
What does it mean when “no migration” is allowed for a substance?
The substance’s concentration must be below the analytical method’s Limit Of Detection (LOD), but does not mean absolutely 0 migration.
What are the main differences between FDA’s regulation (CFR Title 21 Part 179-186) and ESFA’s regulation ( EC 1935/2004 and EC 10/2011) regarding recommendations on overall migration limits of substances into infant formula / milk powder?
1) Age
- FDA → infants from 0-6 months
- ESFA → infants from 0-6 months and children from 1-3 years old
2) Overall migration limits and food
- FDA : expressed as mg / kg of food
- ESFA : no more than 60 mg / kg of food simulant
EU regulations : EFSA ( European Food Safety Authority)
Under Article 13 of EU 10/2011, plastic layers that are not directly in contact with food and separated by a plastic layer is subject to the regulations as specified in EU 10/2011. True or False?
Largely false, these layers may not comply with the restrictions and regulations set, except vinyl chloride monomer (PVC)
EU regulations : EFSA ( European Food Safety Authority)
Under Article 13 of EU 10/2011, plastic layers that are not directly in contact with food and separated by a plastic layer must be manufactured with FCS in the positive list. True or False/
False, these plastic materials can be manufactured with substances not in the Union list (positive list), but shall not migrate into food or food simulant ;; and migration limits shall include set-off transfer
