Transcript FCN 772 - RadTech

FCN 772
Legal and Regulatory
Aspects
May 5, 2008
Martha Marrapese
Partner
Keller and Heckman LLP
1001 G St, NW Suite 500
Washington, DC 20001
202-434-4123
[email protected]
www.khlaw.com
Washington, D.C. www.khlaw.com
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Legal Framework
• A food additive is defined as a
substance that is “reasonably expected
to become a component of food under
the intended conditions of use”
• Considered “unsafe” unless it is used in
accordance with an applicable food
additive regulation or clearance
• Uncleared food additives are
automatically unsafe and adulterated
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A UV/EB Coating, Adhesive, Or
Ink Complies With The Act If :
1.
2.
3.
4.
Its use complies with an existing food additive
regulation, e.g., 21 CFR § 176.170, 21 CFR §
178.3297 or FCN;
Its components are the subject of a prior FDA or United
States Department of Agriculture (USDA) sanction or
approval prior to 1958;
Its components are deemed GRAS; or
It is not reasonably expected to
become a component of food, based
on appropriate extraction studies or
equivalent data
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Subsets of “No Migration”
• All depend on intended conditions of
use and migration calculations or data
- Functional Barrier
- Basic Resin Doctrine
- Housewares
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Legal Framework, cont.
• Food Contact Notification (FCN)
Pre-market notification to FDA
Information supporting the conclusion
that the substance is safe for the
intended use(s)
If no objection within 120 days, the
submitter may market the product
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FCNs, cont.
• FCNs are proprietary to notifier
identified in filing
• Customers may rely on supplier’s
notification
• FDA issues a letter to the notifier stating
that the notification is effective
• Notifications will not appear in CFR or
Federal Register; FDA lists effective
FCNs on its web site
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Food Packaging Alliance
In Plain Terms
A formulator may combine the
Alliance FCN materials with already
FDA sanctioned components to offer
inks, coatings, and adhesives
suitable for food packaging, in many
cases without having to obtain
additional clearances.
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Examples of Useful Clearances
• Can coatings
 21 CFR § 175.300 (pertaining to metal substrates or
repeated use applications)
• Paper coatings
 21 CFR § 176.170 and/or 21 CFR §176.180
• Films
 Polyolefins described in 21 CFR § 177.1520(c)2.2 or 3.2a
may be used in cooking
 Polyolefins in 21 CFR 177.1520(c)2.1 or (c)3.1a are only
permitted for non-cooking applications
 21 CFR § 175.320 lists cleared resinous and polymeric
coatings for polyolefin films
• Inks
 Many ink components can be found in 21 CFR § 178.3297
(Colorants for polymers)
 Or, if used in paper applications, under 21 CFR § 76.170
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What is the Food Contact Substance?
• A mixture of one or more of
TPGDA
TMPTA
TMPEOTA
BADGEDA
optionally containing ESACURE ONE
• Cleared effective March 7, 2008
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What are the Cleared Conditions of Use?
A - High temperature heat-sterilized (e.g., over 212°F)
B - Boiling water sterilized
C - Hot filled or pasteurized above 150°F
D - Hot filled or pasteurized below 150°F
E - Room temperature filled and stored (no thermal
treatment in the container)
F - Refrigerated storage (no thermal treatment in the
container)
G - Frozen storage (no thermal treatment in the
container)
H - Frozen or refrigerated storage: Ready-prepared
foods intended to be reheated in container at time of
use
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What types of packaging?
• Food contact layers and non-food
contact layers
• To be used as coatings (including inks)
or components of coatings (including
inks) on
Polymeric substrates
Paper and paperboard
Metal substrates, or
as a component in Adhesives.
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Who can use the Clearance?
• Only companies listed in FCN 772 as
the notifiers and their customers may
rely on the clearance to manufacture
food packaging materials
• The acrylates and photoinitiator must be
supplied by an FCN-listed company
• Competitors must file their own FCNs
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What Information is Public?
• Identity of Food Contact Substances
(FCS)
• Identity of the Notifiers
• Intended conditions of use
• Maximum use level
• Types of food that may contact the FCS
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What to Tell Customers?
• Some consumer product end users insist on
seeing an FDA listing or regulation
• Reference FCN 772:
“This product is cleared for broad use in
food packaging by FCN 772, with a
maximum extraction level of 10 μg/in2 for
the substance and 10 μg/in2 for total
extractables (TE). See
http://www.cfsan.fda.gov/~dms/opa-fcn.html”
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What is the Maximum Limit?
• 10 μg/in2 per acrylate, for the photoinitiator,
and for total extractables (TE)
• Example: Assume making a UV-cured foodcontact surface
 TMPTA and TMPEOTA as monomers
 ESACURE ONE as photoinitiator
 Also use an antioxidant suitably cleared under 21
CFR
 The resin is cured as a coating on a polyolefin film
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Example, cont.
• Run end-test using testing conditions
required for intended use:
TMPTA 5 μg/in2 (0.5 ppm)
TMPEOTA 7 μg/in2 (0.7 ppm)
ESACURE ONE 4 μg/in2 (0.4 ppm)
Total Extractables (TE) 25 μg/in2 (2.5 ppm)
• This meets end-test requirements
because
25μg/in2-5μg/in2-7μg/in2-4μg/in2 =
9μg/in2 TE
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What Verification is Needed?
• Extraction test and analysis in FCN
Protocol is proprietary RadTech Alliance
Members and customers
• Can another method be used?
Yes, if equivalent
• How often do you have to test?
As often as necessary. E.g., initially, six
months, any process changes
• Who tests?
The company that is using the product
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When Is a New FCN Required?
• If substance made by different
manufacturer/notifier than identified in FCN
• New conditions or levels of use (NEW FCN, not
amendment of old)
• When specifications of FCS substantively
change
• When changes made in manufacture that
substantively change:
- Product identity
- Purity profile
- Good Manufacturing Practices (GMP) changes
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Can the FCN be Transferred/Assigned?
• E.g., Notifier undergoes company name
change (acquisition, corporate reorganization,
etc.), or Notifier uses toll manufacturer or
subsidiary for manufacture
- no new FCN needed, providing process and
chemical identity submitted stays the same
- For transfer, submit letter to FDA requesting
modification of FCN website list to reflect new
company name
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What to do When you Suspect a
Non-FCN Supplied Material?
• Uncleared food additives are automatically
unsafe and adulterated
• After food has been packaged, can lead to
claims for direct damages (the value of the
packaged food) far out of proportion to the
value of the packaging materials themselves.
 Also additional consequential or incidental
damages such as loss of future sales from
damage to a brand's reputation with consumers.
• Bottom line: if there is a problem, the
damages can add up fast
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Enforcement, cont.
• FDA’s actions can include issuing a warning
letter, requesting a recall of affected products,
requiring a recall if potential exposure is
harmful enough, and issuing a fine.
• What action FDA will take depends upon the
safety implications raised by the uncleared
additive.
• The person may inform the company of its
suspicion to seek clarification for the purpose
of determining if additional action is
warranted, such as informing FDA of the
suspected activity.
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How to Build on FCN 772?
• Alliance members and their customers
can reference the Alliance FCN in new
FCN filings
• Less additional effort to obtain
clearance for an uncleared component
in a new proprietary formulation
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Thank you!
Martha Marrapese
Partner
Keller and Heckman LLP
1001 G St, NW Suite 500
Washington, DC 20001
202-434-4123
[email protected]
www.khlaw.com
Washington, D.C. www.khlaw.com
● Brussels ● San Francisco ● Shanghai
Copyright © 2007