+---------+------+-----------------+-----------------+-----------------+
| Form    |      |                 |                 |                 |
| Ap      |      |                 |                 |                 |
| proved: |      |                 |                 |                 |
| OMB No. |      |                 |                 |                 |
| 091     |      |                 |                 |                 |
| 0-0495, |      |                 |                 |                 |
| A       |      |                 |                 |                 |
| pproval |      |                 |                 |                 |
| E       |      |                 |                 |                 |
| xpires: |      |                 |                 |                 |
| D       |      |                 |                 |                 |
| ecember |      |                 |                 |                 |
| 31,     |      |                 |                 |                 |
| 2008    |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
| Dep     |      |                 | **AGENCY USE    |                 |
| artment |      |                 | ONLY**          |                 |
| of      |      |                 |                 |                 |
| Health  |      |                 |                 |                 |
| and     |      |                 |                 |                 |
| Human   |      |                 |                 |                 |
| Se      |      |                 |                 |                 |
| rvices\ |      |                 |                 |                 |
| Food    |      |                 |                 |                 |
| and     |      |                 |                 |                 |
| Drug    |      |                 |                 |                 |
| Adminis |      |                 |                 |                 |
| tration |      |                 |                 |                 |
|         |      |                 |                 |                 |
| **NOTIF |      |                 |                 |                 |
| ICATION |      |                 |                 |                 |
| FOR NEW |      |                 |                 |                 |
| USE OF  |      |                 |                 |                 |
| A       |      |                 |                 |                 |
| FOOD**  |      |                 |                 |                 |
|         |      |                 |                 |                 |
| **      |      |                 |                 |                 |
| CONTACT |      |                 |                 |                 |
| SUBS    |      |                 |                 |                 |
| TANCE** |      |                 |                 |                 |
|         |      |                 |                 |                 |
| **FOR   |      |                 |                 |                 |
| NEW     |      |                 |                 |                 |
| USES OF |      |                 |                 |                 |
| FOOD    |      |                 |                 |                 |
| CONTACT |      |                 |                 |                 |
| SUBST   |      |                 |                 |                 |
| ANCES** |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
|         |      |                 | DATE OF RECEIPT |                 |
|         |      |                 |                 |                 |
|         |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
|         |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
| **When  | NOTI |                 |                 |                 |
| com     | FICA |                 |                 |                 |
| pleted\ | TION |                 |                 |                 |
| send    | CON  |                 |                 |                 |
| the     | TROL |                 |                 |                 |
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| and\    | SSIS |                 |                 |                 |
| notif   | TANT |                 |                 |                 |
| ication |      |                 |                 |                 |
| to:**   | OF   |                 |                 |                 |
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|         | OF   |                 |                 |                 |
|         | FOOD |                 |                 |                 |
|         | ADDI |                 |                 |                 |
|         | TIVE |                 |                 |                 |
|         | SA   |                 |                 |                 |
|         | FETY |                 |                 |                 |
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|         | HFS  |                 |                 |                 |
|         | -275 |                 |                 |                 |
|         |      |                 |                 |                 |
|         | 5100 |                 |                 |                 |
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|         | PAR  |                 |                 |                 |
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|         |      |                 |                 |                 |
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|         | P    |                 |                 |                 |
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|         | MD   |                 |                 |                 |
|         | 20   |                 |                 |                 |
|         | 740- |                 |                 |                 |
|         | 3835 |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
|         |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
|         |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
| Enter   |      |                 | DATE EFFECTIVE  | FCN NUMBER      |
| the     |      |                 | *(if            |                 |
| total   |      |                 | effective)*     |                 |
| number  |      |                 |                 |                 |
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| cation: |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
| **      |      |                 |                 |                 |
| GENERAL |      |                 |                 |                 |
| INSTRUC |      |                 |                 |                 |
| TIONS** |      |                 |                 |                 |
|         |      |                 |                 |                 |
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|         |      |                 |                 |                 |
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|     sub |      |                 |                 |                 |
| stance. |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
| >       |      |                 | **Part III -    |                 |
|  **Part |      |                 | TOXICOLOGY      |                 |
| > I -   |      |                 | INFORMATION**   |                 |
| >       |      |                 |                 |                 |
| GENERAL |      |                 | Include a list  |                 |
| >       |      |                 | of toxicology   |                 |
|  INFORM |      |                 | studies         |                 |
| ATION** |      |                 | considered key  |                 |
| >       |      |                 | to the safety\  |                 |
| > Only  |      |                 | decision,       |                 |
| > one   |      |                 | discuss the     |                 |
| > new   |      |                 | potential       |                 |
| > food  |      |                 | mutagenicity    |                 |
| >       |      |                 | and             |                 |
| contact |      |                 | carcinogenicity |                 |
| > su    |      |                 | of\             |                 |
| bstance |      |                 | the notified    |                 |
| > (FCS) |      |                 | substance and   |                 |
| > may   |      |                 | its             |                 |
| > be    |      |                 | constituents,   |                 |
| > the   |      |                 | determine the   |                 |
| >       |      |                 | acceptable\     |                 |
| subject |      |                 | daily intake    |                 |
| > of a\ |      |                 | (ADI), as       |                 |
| > par   |      |                 | appropriate,    |                 |
| ticular |      |                 | and state the   |                 |
| >       |      |                 | basis for your  |                 |
|  notifi |      |                 | safety\         |                 |
| cation. |      |                 | decision. This  |                 |
| > H     |      |                 | information     |                 |
| owever, |      |                 | should be       |                 |
| > new   |      |                 | consistent with |                 |
| > m     |      |                 | the discussion  |                 |
| ultiple |      |                 | in\             |                 |
| > uses  |      |                 | the Safety      |                 |
| > maybe |      |                 | Narrative,      |                 |
| > co    |      |                 | which is        |                 |
| mbined\ |      |                 | described in    |                 |
| > in a  |      |                 | the \"Guidance  |                 |
| >       |      |                 | for\            |                 |
|  notifi |      |                 | Industry:       |                 |
| cation. |      |                 | Preparation of  |                 |
| > A     |      |                 | Premarket       |                 |
| >       |      |                 | Notifications   |                 |
| \"new\" |      |                 | for Food        |                 |
| > use   |      |                 | Contact\        |                 |
| > is    |      |                 | Substances:     |                 |
| > one   |      |                 | Toxicology      |                 |
| > not   |      |                 | Rec             |                 |
| > ot    |      |                 | ommendations.\" |                 |
| herwise |      |                 |                 |                 |
| > auth  |      |                 | **Part VI -     |                 |
| orized. |      |                 | LIST OF         |                 |
| > If\   |      |                 | ATTACHMENTS**   |                 |
| >       |      |                 |                 |                 |
|  author |      |                 | Attach          |                 |
| ization |      |                 | additional      |                 |
| > is    |      |                 | sheets if there |                 |
| >       |      |                 | is not enough   |                 |
|  sought |      |                 | space to answer |                 |
| > for   |      |                 | a\              |                 |
| > use   |      |                 | question fully. |                 |
| > of    |      |                 | Label each      |                 |
| > m     |      |                 | continuation    |                 |
| ultiple |      |                 | sheet with the  |                 |
| > FCSs  |      |                 | corresponding\  |                 |
| > that  |      |                 | section         |                 |
| > are   |      |                 | heading. List   |                 |
| > food\ |      |                 | these           |                 |
| > add   |      |                 | attachments,    |                 |
| itives, |      |                 | any test data   |                 |
| > s     |      |                 | or other data,\ |                 |
| eparate |      |                 | and any         |                 |
| >       |      |                 | optional        |                 |
|  notifi |      |                 | information     |                 |
| cations |      |                 | included in the |                 |
| >       |      |                 | notification.   |                 |
|  should |      |                 | Please do\      |                 |
| > be    |      |                 | not attach      |                 |
| > su    |      |                 | information     |                 |
| bmitted |      |                 | that can be     |                 |
| > for   |      |                 | included on the |                 |
| > each  |      |                 | form.           |                 |
| > new\  |      |                 |                 |                 |
| > use.  |      |                 | **OPTIONAL      |                 |
| > Any   |      |                 | INFORMATION**   |                 |
| > accom |      |                 |                 |                 |
| panying |      |                 | You may include |                 |
| > info  |      |                 | any information |                 |
| rmation |      |                 | that you want   |                 |
| > for a |      |                 | FDA to consider |                 |
| > notif |      |                 | in\             |                 |
| ication |      |                 | evaluating this |                 |
| > may   |      |                 | notification.   |                 |
| > be\   |      |                 |                 |                 |
| > p     |      |                 | **              |                 |
| rovided |      |                 | CONFIDENTIALITY |                 |
| > to    |      |                 | OF              |                 |
| > FDA   |      |                 | INFORMATION**   |                 |
| > in a  |      |                 |                 |                 |
| > Food  |      |                 | By submitting a |                 |
| > A     |      |                 | notification    |                 |
| dditive |      |                 | under section   |                 |
| >       |      |                 | 409(h) of the   |                 |
|  Master |      |                 | Federal\        |                 |
| > File  |      |                 | Food, Drug, and |                 |
| > and   |      |                 | Cosmetic Act    |                 |
| > ref   |      |                 | (21 U.S.C.      |                 |
| erenced |      |                 | 348(h)), a      |                 |
| > in a\ |      |                 | notifier        |                 |
| >       |      |                 | waives\         |                 |
|  notifi |      |                 | any claim to    |                 |
| cation. |      |                 | confidentiality |                 |
| > Any   |      |                 | for information |                 |
| > info  |      |                 | necessary to    |                 |
| rmation |      |                 | describe the\   |                 |
| > ref   |      |                 | food contact    |                 |
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| > notif |      |                 | conditions of   |                 |
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| > must  |      |                 | the\            |                 |
| > be\   |      |                 | subject of the  |                 |
| > su    |      |                 | notification.   |                 |
| bmitted |      |                 | If you are      |                 |
| > to    |      |                 | claiming any    |                 |
| > FDA   |      |                 | information in  |                 |
| > prior |      |                 | this\           |                 |
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| > your  |      |                 | be confidential |                 |
| >       |      |                 | you should      |                 |
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| cation. |      |                 | confidential\   |                 |
| > If    |      |                 | material in     |                 |
| > you   |      |                 | writing, or     |                 |
| > ref   |      |                 | otherwise mark  |                 |
| erence\ |      |                 | the             |                 |
| > info  |      |                 | confidential    |                 |
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| > a     |      |                 | notification    |                 |
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| > party |      |                 | drawing a line  |                 |
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| > is    |      |                 | submit a        |                 |
| >       |      |                 | separate\       |                 |
| located |      |                 | redacted copy   |                 |
| > in    |      |                 | of the          |                 |
| > other |      |                 | notification.   |                 |
| > FDA   |      |                 | FDA may         |                 |
| >       |      |                 | disagree        |                 |
| files,\ |      |                 | regarding the\  |                 |
| >       |      |                 | disclosability  |                 |
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| >       |      |                 | confidential.   |                 |
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| rtinent |      |                 |                 |                 |
| > info  |      |                 |                 |                 |
| rmation |      |                 |                 |                 |
| > con   |      |                 |                 |                 |
| cerning |      |                 |                 |                 |
| > the   |      |                 |                 |                 |
| > FCS   |      |                 |                 |                 |
| > that  |      |                 |                 |                 |
| > is    |      |                 |                 |                 |
| > the\  |      |                 |                 |                 |
| >       |      |                 |                 |                 |
| subject |      |                 |                 |                 |
| > of    |      |                 |                 |                 |
| > the   |      |                 |                 |                 |
| >       |      |                 |                 |                 |
|  notifi |      |                 |                 |                 |
| cation. |      |                 |                 |                 |
| > This  |      |                 |                 |                 |
| >       |      |                 |                 |                 |
|  should |      |                 |                 |                 |
| > i     |      |                 |                 |                 |
| nclude: |      |                 |                 |                 |
| > c     |      |                 |                 |                 |
| hemical |      |                 |                 |                 |
| > ide   |      |                 |                 |                 |
| ntity,\ |      |                 |                 |                 |
| >       |      |                 |                 |                 |
|  manufa |      |                 |                 |                 |
| cturing |      |                 |                 |                 |
| > p     |      |                 |                 |                 |
| rocess, |      |                 |                 |                 |
| > p     |      |                 |                 |                 |
| hysical |      |                 |                 |                 |
| > pro   |      |                 |                 |                 |
| perties |      |                 |                 |                 |
| > and   |      |                 |                 |                 |
| > sp    |      |                 |                 |                 |
| ecifica |      |                 |                 |                 |
| tions,\ |      |                 |                 |                 |
| > con   |      |                 |                 |                 |
| ditions |      |                 |                 |                 |
| > of    |      |                 |                 |                 |
| > use,  |      |                 |                 |                 |
| > i     |      |                 |                 |                 |
| ntended |      |                 |                 |                 |
| > te    |      |                 |                 |                 |
| chnical |      |                 |                 |                 |
| >       |      |                 |                 |                 |
| effect, |      |                 |                 |                 |
| > and   |      |                 |                 |                 |
| > st    |      |                 |                 |                 |
| ability |      |                 |                 |                 |
| > data. |      |                 |                 |                 |
| > In\   |      |                 |                 |                 |
| > a     |      |                 |                 |                 |
| ddition |      |                 |                 |                 |
| > to    |      |                 |                 |                 |
| > the   |      |                 |                 |                 |
| >       |      |                 |                 |                 |
| summary |      |                 |                 |                 |
| > info  |      |                 |                 |                 |
| rmation |      |                 |                 |                 |
| > pr    |      |                 |                 |                 |
| ovided, |      |                 |                 |                 |
| > your  |      |                 |                 |                 |
| >       |      |                 |                 |                 |
|  notifi |      |                 |                 |                 |
| cation\ |      |                 |                 |                 |
| >       |      |                 |                 |                 |
|  should |      |                 |                 |                 |
| >       |      |                 |                 |                 |
| include |      |                 |                 |                 |
| > all   |      |                 |                 |                 |
| > sup   |      |                 |                 |                 |
| porting |      |                 |                 |                 |
| > info  |      |                 |                 |                 |
| rmation |      |                 |                 |                 |
| > or    |      |                 |                 |                 |
| > data. |      |                 |                 |                 |
| > Also, |      |                 |                 |                 |
| > i     |      |                 |                 |                 |
| nclude\ |      |                 |                 |                 |
| > suf   |      |                 |                 |                 |
| ficient |      |                 |                 |                 |
| > data  |      |                 |                 |                 |
| > to    |      |                 |                 |                 |
| >       |      |                 |                 |                 |
|  enable |      |                 |                 |                 |
| > FDA   |      |                 |                 |                 |
| > to    |      |                 |                 |                 |
| >       |      |                 |                 |                 |
| confirm |      |                 |                 |                 |
| > your  |      |                 |                 |                 |
| > es    |      |                 |                 |                 |
| timated |      |                 |                 |                 |
| > daily |      |                 |                 |                 |
| >       |      |                 |                 |                 |
| intake\ |      |                 |                 |                 |
| > re    |      |                 |                 |                 |
| sulting |      |                 |                 |                 |
| > from  |      |                 |                 |                 |
| > the   |      |                 |                 |                 |
| > i     |      |                 |                 |                 |
| ntended |      |                 |                 |                 |
| > use   |      |                 |                 |                 |
| > of    |      |                 |                 |                 |
| > the   |      |                 |                 |                 |
| > sub   |      |                 |                 |                 |
| stance. |      |                 |                 |                 |
| > For   |      |                 |                 |                 |
| > info  |      |                 |                 |                 |
| rmation |      |                 |                 |                 |
| > on\   |      |                 |                 |                 |
| > r     |      |                 |                 |                 |
| ecommen |      |                 |                 |                 |
| dations |      |                 |                 |                 |
| > on    |      |                 |                 |                 |
| > mi    |      |                 |                 |                 |
| gration |      |                 |                 |                 |
| >       |      |                 |                 |                 |
| testing |      |                 |                 |                 |
| > and   |      |                 |                 |                 |
| > prese |      |                 |                 |                 |
| ntation |      |                 |                 |                 |
| > of    |      |                 |                 |                 |
| > the\  |      |                 |                 |                 |
| > ch    |      |                 |                 |                 |
| emistry |      |                 |                 |                 |
| > info  |      |                 |                 |                 |
| rmation |      |                 |                 |                 |
| > see   |      |                 |                 |                 |
| > \"G   |      |                 |                 |                 |
| uidance |      |                 |                 |                 |
| > for   |      |                 |                 |                 |
| > In    |      |                 |                 |                 |
| dustry: |      |                 |                 |                 |
| > Prep  |      |                 |                 |                 |
| aration |      |                 |                 |                 |
| > of\   |      |                 |                 |                 |
| > Pr    |      |                 |                 |                 |
| emarket |      |                 |                 |                 |
| >       |      |                 |                 |                 |
|  Notifi |      |                 |                 |                 |
| cations |      |                 |                 |                 |
| > and   |      |                 |                 |                 |
| > Food  |      |                 |                 |                 |
| > A     |      |                 |                 |                 |
| dditive |      |                 |                 |                 |
| > Pe    |      |                 |                 |                 |
| titions |      |                 |                 |                 |
| > for   |      |                 |                 |                 |
| > Food\ |      |                 |                 |                 |
| >       |      |                 |                 |                 |
| Contact |      |                 |                 |                 |
| > Subs  |      |                 |                 |                 |
| tances: |      |                 |                 |                 |
| > Ch    |      |                 |                 |                 |
| emistry |      |                 |                 |                 |
| > Reco  |      |                 |                 |                 |
| mmendat |      |                 |                 |                 |
| ions.\" |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+
| ##      |      |                 |                 |                 |
| #### PU |      |                 |                 |                 |
| BLIC BU |      |                 |                 |                 |
| RDEN ST |      |                 |                 |                 |
| ATEMENT |      |                 |                 |                 |
|         |      |                 |                 |                 |
| Public  |      |                 |                 |                 |
| re      |      |                 |                 |                 |
| porting |      |                 |                 |                 |
| burden  |      |                 |                 |                 |
| for     |      |                 |                 |                 |
| this    |      |                 |                 |                 |
| col     |      |                 |                 |                 |
| lection |      |                 |                 |                 |
| of      |      |                 |                 |                 |
| info    |      |                 |                 |                 |
| rmation |      |                 |                 |                 |
| is      |      |                 |                 |                 |
| es      |      |                 |                 |                 |
| timated |      |                 |                 |                 |
| to      |      |                 |                 |                 |
| average |      |                 |                 |                 |
| 25      |      |                 |                 |                 |
| hours   |      |                 |                 |                 |
| per     |      |                 |                 |                 |
| re      |      |                 |                 |                 |
| sponse, |      |                 |                 |                 |
| in      |      |                 |                 |                 |
| cluding |      |                 |                 |                 |
| the     |      |                 |                 |                 |
| time    |      |                 |                 |                 |
| for     |      |                 |                 |                 |
| re      |      |                 |                 |                 |
| viewing |      |                 |                 |                 |
| instru  |      |                 |                 |                 |
| ctions, |      |                 |                 |                 |
| sea     |      |                 |                 |                 |
| rching\ |      |                 |                 |                 |
| e       |      |                 |                 |                 |
| xisting |      |                 |                 |                 |
| data    |      |                 |                 |                 |
| s       |      |                 |                 |                 |
| ources, |      |                 |                 |                 |
| ga      |      |                 |                 |                 |
| thering |      |                 |                 |                 |
| and     |      |                 |                 |                 |
| main    |      |                 |                 |                 |
| taining |      |                 |                 |                 |
| the     |      |                 |                 |                 |
| data    |      |                 |                 |                 |
| needed, |      |                 |                 |                 |
| and     |      |                 |                 |                 |
| com     |      |                 |                 |                 |
| pleting |      |                 |                 |                 |
| re      |      |                 |                 |                 |
| viewing |      |                 |                 |                 |
| the     |      |                 |                 |                 |
| col     |      |                 |                 |                 |
| lection |      |                 |                 |                 |
| of      |      |                 |                 |                 |
| infor   |      |                 |                 |                 |
| mation. |      |                 |                 |                 |
| Send    |      |                 |                 |                 |
| c       |      |                 |                 |                 |
| omments |      |                 |                 |                 |
| re      |      |                 |                 |                 |
| garding |      |                 |                 |                 |
| this    |      |                 |                 |                 |
| burden\ |      |                 |                 |                 |
| e       |      |                 |                 |                 |
| stimate |      |                 |                 |                 |
| or any  |      |                 |                 |                 |
| other   |      |                 |                 |                 |
| aspect  |      |                 |                 |                 |
| of this |      |                 |                 |                 |
| col     |      |                 |                 |                 |
| lection |      |                 |                 |                 |
| of      |      |                 |                 |                 |
| infor   |      |                 |                 |                 |
| mation, |      |                 |                 |                 |
| in      |      |                 |                 |                 |
| cluding |      |                 |                 |                 |
| sugg    |      |                 |                 |                 |
| estions |      |                 |                 |                 |
| for     |      |                 |                 |                 |
| r       |      |                 |                 |                 |
| educing |      |                 |                 |                 |
| this    |      |                 |                 |                 |
| burden  |      |                 |                 |                 |
| to:     |      |                 |                 |                 |
| Food    |      |                 |                 |                 |
| and     |      |                 |                 |                 |
| Drug    |      |                 |                 |                 |
| A       |      |                 |                 |                 |
| dminist |      |                 |                 |                 |
| ration, |      |                 |                 |                 |
| Center  |      |                 |                 |                 |
| for     |      |                 |                 |                 |
| Food\   |      |                 |                 |                 |
| Safety  |      |                 |                 |                 |
| and     |      |                 |                 |                 |
| Applied |      |                 |                 |                 |
| Nut     |      |                 |                 |                 |
| rition, |      |                 |                 |                 |
| Office  |      |                 |                 |                 |
| of Food |      |                 |                 |                 |
| A       |      |                 |                 |                 |
| dditive |      |                 |                 |                 |
| Safety  |      |                 |                 |                 |
| (0910   |      |                 |                 |                 |
| -0495), |      |                 |                 |                 |
| 5100    |      |                 |                 |                 |
| Paint   |      |                 |                 |                 |
| Branch  |      |                 |                 |                 |
| Parkway |      |                 |                 |                 |
| (HF     |      |                 |                 |                 |
| S-200), |      |                 |                 |                 |
| College |      |                 |                 |                 |
| Park,   |      |                 |                 |                 |
| MD      |      |                 |                 |                 |
| 2074    |      |                 |                 |                 |
| 0-3835. |      |                 |                 |                 |
| An      |      |                 |                 |                 |
| agency\ |      |                 |                 |                 |
| may not |      |                 |                 |                 |
| conduct |      |                 |                 |                 |
| or      |      |                 |                 |                 |
| s       |      |                 |                 |                 |
| ponsor, |      |                 |                 |                 |
| and a   |      |                 |                 |                 |
| person  |      |                 |                 |                 |
| is not  |      |                 |                 |                 |
| r       |      |                 |                 |                 |
| equired |      |                 |                 |                 |
| to      |      |                 |                 |                 |
| respond |      |                 |                 |                 |
| to a    |      |                 |                 |                 |
| col     |      |                 |                 |                 |
| lection |      |                 |                 |                 |
| of      |      |                 |                 |                 |
| info    |      |                 |                 |                 |
| rmation |      |                 |                 |                 |
| unless  |      |                 |                 |                 |
| it      |      |                 |                 |                 |
| d       |      |                 |                 |                 |
| isplays |      |                 |                 |                 |
| a       |      |                 |                 |                 |
| cu      |      |                 |                 |                 |
| rrently |      |                 |                 |                 |
| valid   |      |                 |                 |                 |
| OMB     |      |                 |                 |                 |
| control |      |                 |                 |                 |
| number. |      |                 |                 |                 |
+---------+------+-----------------+-----------------+-----------------+

<table style="width:100%;">
<colgroup>
<col style="width: 15%" />
<col style="width: 13%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 1%" />
<col style="width: 4%" />
<col style="width: 2%" />
<col style="width: 2%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 8%" />
<col style="width: 1%" />
<col style="width: 3%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 3%" />
<col style="width: 3%" />
<col style="width: 1%" />
<col style="width: 9%" />
<col style="width: 8%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="24"><strong>PART I - GENERAL INFORMATION</strong></td>
</tr>
<tr class="even">
<td rowspan="5"><strong>1a. PERSON<br />
SUBMITTING<br />
NOTICE</strong></td>
<td colspan="13"><p>NAME OF AUTHORIZED OFFICIAL</p>
<p>     </p></td>
<td colspan="10"><p>POSITION</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="23"><p>COMPANY</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="23"><p>MAILING ADDRESS <em>(number and street)</em></p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="5"><p>CITY</p>
<p>     </p></td>
<td colspan="7"><p>STATE</p>
<p>     </p></td>
<td colspan="7"><p>ZIP CODE/POSTAL CODE</p>
<p>     </p></td>
<td colspan="4"><p>COUNTRY</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="5"><p>TELEPHONE NUMBER</p>
<p>     </p></td>
<td colspan="11"><p>FAX NUMBER</p>
<p>     </p></td>
<td colspan="7"><p>E-MAIL ADDRESS</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="24"><blockquote>
<p> Please check here if E-Mail is your preferred method of
communication. <em>(Please note that E-Mails may not be secure)</em></p>
</blockquote></td>
</tr>
<tr class="even">
<td rowspan="5"><strong>1a. AGENT <em>(if applicable)</em></strong></td>
<td colspan="13"><p>NAME OF AUTHORIZED OFFICIAL</p>
<p>     </p></td>
<td colspan="10"><p>POSITION</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="23"><p>COMPANY</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="23"><p>MAILING ADDRESS <em>(number and street)</em></p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="5"><p>CITY</p>
<p>     </p></td>
<td colspan="7"><p>STATE</p>
<p>     </p></td>
<td colspan="7"><p>ZIP CODE/POSTAL CODE</p>
<p>     </p></td>
<td colspan="4"><p>COUNTRY</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="5"><p>TELEPHONE NUMBER</p>
<p>     </p></td>
<td colspan="11"><p>FAX NUMBER</p>
<p>     </p></td>
<td colspan="7"><p>E-MAIL ADDRESS</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="24"><blockquote>
<p> Please check here if E-Mail is your preferred method of
communication. <em>(Please note that E-Mails may not be secure)</em></p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="24"><p>c. IDENTIFY THE MANUFACTURER/SUPPLIER FOR WHICH THIS
FCN WILL BECOME EFFECTIVE</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="8">2 If you had a prenotification consultation (PNC) or a
corre-spondence letter (CTS) concerning this notification and FDA
assigned a PNC or CTS number to the consultation, enter the number.</td>
<td colspan="3"><img src="media/image1.png"
style="width:0.33264in;height:0.16944in" /></td>
<td colspan="8">     </td>
<td colspan="3">Mark (X)<br />
if None</td>
<td><img src="media/image1.png"
style="width:0.33264in;height:0.16944in" /></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8">3 Please site all food master files (FMFs) relevant to
this FCN.</td>
<td colspan="3"><img src="media/image1.png"
style="width:0.33264in;height:0.16944in" /></td>
<td colspan="8">     </td>
<td colspan="3">Mark (X)<br />
if None</td>
<td><img src="media/image1.png"
style="width:0.33264in;height:0.16944in" /></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="8">4 If you previously submitted an FCN or FAP for
this<br />
substance that is not effective, enter the FCN or FAP<br />
number assigned by FDA.</td>
<td colspan="3"><img src="media/image1.png"
style="width:0.33264in;height:0.16944in" /></td>
<td colspan="8">     </td>
<td colspan="3">Mark (X)<br />
if None</td>
<td><img src="media/image1.png"
style="width:0.33264in;height:0.16944in" /></td>
<td></td>
</tr>
<tr class="even">
<td colspan="8"><p>5 List all effective notifications for the
substance.</p>
<blockquote>
<p>FDA maintains a list of effective notifications accessible<br />
through its internet site at:</p>
<p>http://www.cfsan.fda.gov/~dms/opa-fcn.html</p>
</blockquote></td>
<td colspan="3"><img src="media/image1.png"
style="width:0.33264in;height:0.16944in" /></td>
<td colspan="8">     </td>
<td colspan="3">Mark (X)<br />
if None</td>
<td><img src="media/image1.png"
style="width:0.33264in;height:0.16944in" /></td>
<td></td>
</tr>
<tr class="odd">
<td colspan="24"><strong>Part II - CHEMISTRY INFORMATION</strong></td>
</tr>
<tr class="even">
<td colspan="24"><p><strong>SECTION A - IDENTIFICATION OF THE FOOD
CONTACT SUBSTANCE</strong></p>
<p><em>See Chemistry Recommendations, Sections II.A.1 through
4.</em></p></td>
</tr>
<tr class="odd">
<td colspan="24"><p>1. Chemical Abstracts Service (CAS) name</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="24"><p>2. CAS Registry Number</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="24"><p>3 . Trade or Common Name</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="24"><p>4. Other Chemical Names <em>(IUPAC, etc.)</em></p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="24"><p>5. Description</p>
<blockquote>
<p>Provide a description of the FCS, including chemical formula(s),
structure(s) and molecular weight(s). For FCSs that cannot be
represented by a<br />
discrete chemical structure, such as new polymers, provide a
representative chemical structure(s) and the Mw and Mn. For new
copolymers,<br />
also provide the ratio of monomer units in the copolymer.</p>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="odd">
<td colspan="24"><p>6. Characterization</p>
<blockquote>
<p>Attach data, such as infrared (IR), ultraviolet (UV), nuclear
magnetic resonance (NMR), mass spectra, or other similar data for
identification of<br />
the FCS.</p>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="odd">
<td colspan="24"><strong>Part II - CHEMISTRY INFORMATION</strong>
<em>(continued)</em></td>
</tr>
<tr class="even">
<td colspan="24"><h6 id="section-b---manufacture">SECTION B -
MANUFACTURE</h6>
<p><em>See Chemistry Recommendations, Sections II.A.4.a through
d.</em></p></td>
</tr>
<tr class="odd">
<td colspan="24">1. List all reagents monomers, solvents, catalyst
systems, purification aids, etc. used to manufacture the FCS. Include
chemical name, CAS Reg.<br />
No., and function in the manufacture of the FCS.</td>
</tr>
<tr class="even">
<td colspan="7"><strong>CHEMICAL NAME</strong></td>
<td colspan="7"><strong>CAS REG.<br />
NO.</strong></td>
<td colspan="7"><strong>FUNCTION</strong></td>
<td colspan="3"><strong>Is residual expected<br />
to remain in the<br />
final food contact material?†</strong></td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="7">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="24">† If yes, include in Table II.B.3. If no support this
conclusion in the manufacturing process description (#2).</td>
</tr>
<tr class="odd">
<td colspan="24"><p>2. Describe the manufacturing process, including
reaction conditions (e.g., times and temperatures), and include chemical
equations and<br />
stoichiometry for all synthetic steps and side reactions. Describe any
purification steps.</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="odd">
<td colspan="24"><strong>Part II - CHEMISTRY INFORMATION</strong>
<em>(continued)</em></td>
</tr>
<tr class="even">
<td colspan="24"><p><strong>SECTION B – MANUFACTURE</strong>
<em>(continued)</em></p>
<p><em>See Chemistry Recommendations, Sections II.A.4.a through
d.</em></p></td>
</tr>
<tr class="odd">
<td colspan="24">3. List impurities in the FCS including: the chemical
names, CAS Reg. Nos., and typical and maximum residual levels (percent
weight) in the FCS as<br />
it will be marketed. For FCSs that are polymers, include typical and
maximum residual monomer concentrations. Provide supporting data<br />
including analytical methods and validation information.</td>
</tr>
<tr class="even">
<td colspan="5"><strong>CHEMICAL NAME</strong></td>
<td colspan="5"><strong>CAS REG.<br />
NO.</strong></td>
<td colspan="5"><strong>TYPICAL RESIDUAL<br />
(%)</strong></td>
<td colspan="6"><p><strong>MAXIMUM RESIDUAL</strong></p>
<p><strong>(%)</strong></p></td>
<td colspan="3"><p><strong>Is residual expected</strong></p>
<p><strong>to migrate from the final</strong></p>
<p><strong>food contact material?†</strong></p></td>
</tr>
<tr class="odd">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="odd">
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="3"> Yes No</td>
</tr>
<tr class="even">
<td colspan="24"><p>† If yes, ensure that exposures to these substances
are addressed in Section II.G of this form. If no, provide an
explanation below.</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="even">
<td colspan="24"><strong>Part II - CHEMISTRY INFORMATION</strong>
<em>(continued)</em></td>
</tr>
<tr class="odd">
<td colspan="24"><p><strong>SECTION C – PHYSICAL/CHEMICAL
SPECIFICATIONS</strong></p>
<p><em>See Chemistry Recommendations, Section II.A.5 and 6</em></p></td>
</tr>
<tr class="even">
<td colspan="24"><p>Provide physical and chemical specifications for the
FCS such as density, melting point, maximum impurity levels, and
solubility in food simulants.<br />
Provide specification test results for at least three production batches
of the FCS and attach methods for establishing compliance with
specifications.<br />
For Values, provide minimum or maximum specification limits or a range,
as appropriate.</p>
<p>1. For the FCS:</p></td>
</tr>
<tr class="odd">
<td colspan="9"><strong>SPECIFICATION</strong></td>
<td colspan="15"><strong>VALUE</strong></td>
</tr>
<tr class="even">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="odd">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="even">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="odd">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="even">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="odd">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="even">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="odd">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="even">
<td colspan="24"><p>2. For polymeric FCSs provide the following
additional information:</p>
<p>a. Polymer Properties and Test Results of Production Batches</p>
<blockquote>
<p>Provide relevant physical data, such as molecular weight
distribution, glass transition points, intrinsic or relative
viscosities, melt flow indices,<br />
morphology, and crystallinity. Analytical methods should be included.
Where appropriate, provide test results for at least three production
batches<br />
of the FCS.</p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="4"><strong>PROPERTY</strong></td>
<td colspan="8"><strong>MAX. VALUE</strong></td>
<td colspan="6"><strong>MIN. VALUE</strong></td>
<td colspan="6"><strong>INDIVIDUAL BATCH VALUES</strong></td>
</tr>
<tr class="even">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="odd">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="odd">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="odd">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="odd">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="even">
<td colspan="4">     </td>
<td colspan="8">     </td>
<td colspan="6">     </td>
<td colspan="6">     </td>
</tr>
<tr class="odd">
<td colspan="24"><strong>Part II - CHEMISTRY INFORMATION</strong>
<em>(continued)</em></td>
</tr>
<tr class="even">
<td colspan="24"><strong>SECTION C – PHYSICAL/CHEMICAL
SPECIFICATIONS</strong> <em>(continued)</em></td>
</tr>
<tr class="odd">
<td colspan="24"><p>b. Molecular Weight Profile of the FCS</p>
<blockquote>
<p>Provide a value for the maximum percentage of oligomeric species (not
including residual monomers, reactants, or solvents) below 1000<br />
Daltons and include supporting data and analytical methods.</p>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="odd">
<td colspan="24"><p><strong>SECTION D - INTENDED USE</strong></p>
<p><em>See Chemistry Recommendations, Sections II.B and
II.C</em></p></td>
</tr>
<tr class="even">
<td colspan="24"><p>1. Describe the intended use of the FCS. Include
maximum use level(s) in food-contact materials, types of food-contact
articles with or in which the<br />
FCS is expected to be used (e.g., films, coatings, molded articles) and
maximum thickness, as applicable. Indicate whether single or repeat
use<br />
(or both) is intended: Single Use Repeat Use</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="even">
<td colspan="24">2. a. For single-use articles, list the food types
expected to contact the FCS, with examples if known. Refer to the food
type classifications in<br />
the chemistry recommondations, when possible. Also provide maximum
temperatures and times of food contact, referring to the conditions of
use<br />
in the chemistry recommondations, when possible. <em>(click here for
example)</em></td>
</tr>
<tr class="odd">
<td colspan="3"><strong>USE</strong></td>
<td colspan="13"><strong>FOOD TYPE</strong></td>
<td colspan="8"><strong>CONDITION OF USE</strong></td>
</tr>
<tr class="even">
<td colspan="3">     </td>
<td colspan="13">     </td>
<td colspan="8">     </td>
</tr>
<tr class="odd">
<td colspan="3">     </td>
<td colspan="13">     </td>
<td colspan="8">     </td>
</tr>
<tr class="even">
<td colspan="24"><strong>Part II - CHEMISTRY INFORMATION</strong>
<em>(continued)</em></td>
</tr>
<tr class="odd">
<td colspan="24"><strong>SECTION D - INTENDED USE</strong>
<em>(continued)</em></td>
</tr>
<tr class="even">
<td colspan="24">2. a. CONTINUED</td>
</tr>
<tr class="odd">
<td colspan="3"><strong>USE</strong></td>
<td colspan="13"><strong>FOOD TYPE</strong></td>
<td colspan="8"><strong>CONDITION OF USE</strong></td>
</tr>
<tr class="even">
<td colspan="3">     </td>
<td colspan="13">     </td>
<td colspan="8">     </td>
</tr>
<tr class="odd">
<td colspan="3">     </td>
<td colspan="13">     </td>
<td colspan="8">     </td>
</tr>
<tr class="even">
<td colspan="3">     </td>
<td colspan="13">     </td>
<td colspan="8">     </td>
</tr>
<tr class="odd">
<td colspan="3">     </td>
<td colspan="13">     </td>
<td colspan="8">     </td>
</tr>
<tr class="even">
<td colspan="24"><p>b. For repeat-use articles, provide a typical use
scenario. Include the highest intended use temperature, maximum
food-contact time for the article,<br />
and typical amount of food contacted over the service lifetime of the
article.</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="even">
<td colspan="24"><strong>Part II - CHEMISTRY INFORMATION</strong>
<em>(continued)</em></td>
</tr>
<tr class="odd">
<td colspan="24"><p>3. State the intended technical effect of the FCS.
Summarize data demonstrating that the FCS will achieve the intended
technical effect.<br />
Specifically address the minimum amount required to achieve the intended
technical effect. Include data as an attachment.</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="odd">
<td colspan="24"><p><strong>SECTION E - STABILITY DATA</strong></p>
<p><em>See Chemistry Recommendations, Section II.D.2</em></p></td>
</tr>
<tr class="even">
<td colspan="24"><p>1. Describe any degradation, decomposition or other
chemical breakdown process (oxidation, photolysis, hydrolysis, etc.)
that the FCS may<br />
undergo during either its intended use in the manufacture of a
food-contact article or during migration testing (if performed) of a
test plaque<br />
containing the FCS. If no degradation is expected, so state.</p>
<blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="odd">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
<tr class="even">
<td colspan="24"><strong>Part II - CHEMISTRY INFORMATION</strong></td>
</tr>
<tr class="odd">
<td colspan="24">2. List the breakdown products for the FCS and provide
CAS names, CAS Reg. Nos., and structures, as appropriate. Address the
amount of any<br />
breakdown products that migrate to food and ensure that exposures to
these substances are addressed in Section II.G of this form.</td>
</tr>
<tr class="even">
<td colspan="2"><strong>SUBSTANCE NAME</strong></td>
<td colspan="7"><strong>CAS REG. NO.</strong></td>
<td colspan="11"><strong>SUBSTANCE NAME</strong></td>
<td colspan="4"><strong>CAS REG. NO.</strong></td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="7">     </td>
<td colspan="11">     </td>
<td colspan="4">     </td>
</tr>
<tr class="even">
<td colspan="9"><strong>STRUCTURE</strong></td>
<td colspan="15"><strong>STRUCTURE</strong></td>
</tr>
<tr class="odd">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="even">
<td colspan="2"><strong>SUBSTANCE NAME</strong></td>
<td colspan="7"><strong>CAS REG. NO.</strong></td>
<td colspan="11"><strong>SUBSTANCE NAME</strong></td>
<td colspan="4"><strong>CAS REG. NO.</strong></td>
</tr>
<tr class="odd">
<td colspan="2">     </td>
<td colspan="7">     </td>
<td colspan="11">     </td>
<td colspan="4">     </td>
</tr>
<tr class="even">
<td colspan="9"><strong>STRUCTURE</strong></td>
<td colspan="15"><strong>STRUCTURE</strong></td>
</tr>
<tr class="odd">
<td colspan="9">     </td>
<td colspan="15">     </td>
</tr>
<tr class="even">
<td colspan="24"> Mark (X) this box if you attach a continuation sheet.
Enter the attachment name and number in Section VI of this form.</td>
</tr>
</tbody>
</table>

+-----------+-----------+-----------+-----------+-----------+-----------+
| **Part    |           |           |           |           |           |
| II -      |           |           |           |           |           |
| CHEMISTRY |           |           |           |           |           |
| INFO      |           |           |           |           |           |
| RMATION** |           |           |           |           |           |
| *(co      |           |           |           |           |           |
| ntinued)* |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **SECTION |           |           |           |           |           |
| F -       |           |           |           |           |           |
| MIGRATION |           |           |           |           |           |
| LEVELS IN |           |           |           |           |           |
| FOOD**    |           |           |           |           |           |
|           |           |           |           |           |           |
| *See      |           |           |           |           |           |
| Chemistry |           |           |           |           |           |
| Recomme   |           |           |           |           |           |
| ndations, |           |           |           |           |           |
| Sections  |           |           |           |           |           |
| II.D and  |           |           |           |           |           |
| Appendix  |           |           |           |           |           |
| II*       |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| Summarize |           |           |           |           |           |
| in        |           |           |           |           |           |
| formation |           |           |           |           |           |
| on        |           |           |           |           |           |
| migration |           |           |           |           |           |
| testing   |           |           |           |           |           |
| and/or    |           |           |           |           |           |
| cal       |           |           |           |           |           |
| culations |           |           |           |           |           |
| in the    |           |           |           |           |           |
| ap        |           |           |           |           |           |
| propriate |           |           |           |           |           |
| sections  |           |           |           |           |           |
| below for |           |           |           |           |           |
| both the  |           |           |           |           |           |
| FCS and   |           |           |           |           |           |
| any       |           |           |           |           |           |
| migrants. |           |           |           |           |           |
| A full    |           |           |           |           |           |
| report    |           |           |           |           |           |
| of\       |           |           |           |           |           |
| all       |           |           |           |           |           |
| a         |           |           |           |           |           |
| nalytical |           |           |           |           |           |
| testing,  |           |           |           |           |           |
| including |           |           |           |           |           |
| detailed  |           |           |           |           |           |
| des       |           |           |           |           |           |
| criptions |           |           |           |           |           |
| of        |           |           |           |           |           |
| met       |           |           |           |           |           |
| hodology, |           |           |           |           |           |
| raw data, |           |           |           |           |           |
| and       |           |           |           |           |           |
| sample    |           |           |           |           |           |
| ins       |           |           |           |           |           |
| trumental |           |           |           |           |           |
| output    |           |           |           |           |           |
| (spectra, |           |           |           |           |           |
| chrom     |           |           |           |           |           |
| atograms, |           |           |           |           |           |
| etc.)     |           |           |           |           |           |
| must\     |           |           |           |           |           |
| be        |           |           |           |           |           |
| attached. |           |           |           |           |           |
|           |           |           |           |           |           |
| If        |           |           |           |           |           |
| exposure  |           |           |           |           |           |
| estimates |           |           |           |           |           |
| are       |           |           |           |           |           |
| d         |           |           |           |           |           |
| etermined |           |           |           |           |           |
| by        |           |           |           |           |           |
| assuming  |           |           |           |           |           |
| 100%      |           |           |           |           |           |
| migration |           |           |           |           |           |
| to food,  |           |           |           |           |           |
| or        |           |           |           |           |           |
| through   |           |           |           |           |           |
| the use   |           |           |           |           |           |
| of other  |           |           |           |           |           |
| methods   |           |           |           |           |           |
| *(see     |           |           |           |           |           |
| Chemistry |           |           |           |           |           |
| Recomme   |           |           |           |           |           |
| ndations\ |           |           |           |           |           |
| II.D.5)*, |           |           |           |           |           |
| skip to   |           |           |           |           |           |
| Section   |           |           |           |           |           |
| II.F.2    |           |           |           |           |           |
| and       |           |           |           |           |           |
| provide   |           |           |           |           |           |
| full      |           |           |           |           |           |
| details   |           |           |           |           |           |
| of all    |           |           |           |           |           |
| calc      |           |           |           |           |           |
| ulations. |           |           |           |           |           |
|           |           |           |           |           |           |
| For       |           |           |           |           |           |
| r         |           |           |           |           |           |
| epeat-use |           |           |           |           |           |
| articles, |           |           |           |           |           |
| estimate  |           |           |           |           |           |
| migrant   |           |           |           |           |           |
| levels in |           |           |           |           |           |
| food      |           |           |           |           |           |
| using     |           |           |           |           |           |
| migration |           |           |           |           |           |
| testing   |           |           |           |           |           |
| and/or    |           |           |           |           |           |
| cal       |           |           |           |           |           |
| culations |           |           |           |           |           |
| which     |           |           |           |           |           |
| take into |           |           |           |           |           |
| account   |           |           |           |           |           |
| the       |           |           |           |           |           |
| amount of |           |           |           |           |           |
| food\     |           |           |           |           |           |
| c         |           |           |           |           |           |
| ontacting |           |           |           |           |           |
| the       |           |           |           |           |           |
| article   |           |           |           |           |           |
| over its  |           |           |           |           |           |
| service   |           |           |           |           |           |
| lifetime  |           |           |           |           |           |
| *(see     |           |           |           |           |           |
| Chemistry |           |           |           |           |           |
| Recomme   |           |           |           |           |           |
| ndations, |           |           |           |           |           |
| Appendix  |           |           |           |           |           |
| II, Part  |           |           |           |           |           |
| 4)*.      |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **1.      |           |           |           |           |           |
| MIGRATION |           |           |           |           |           |
| TESTING   |           |           |           |           |           |
| OPTION**  |           |           |           |           |           |
|           |           |           |           |           |           |
| *See      |           |           |           |           |           |
| Chemistry |           |           |           |           |           |
| Recomme   |           |           |           |           |           |
| ndations, |           |           |           |           |           |
| Sections  |           |           |           |           |           |
| II.D.1    |           |           |           |           |           |
| through   |           |           |           |           |           |
| II.D. 3*  |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| a\.       |           |           |           |           |           |
| Describe  |           |           |           |           |           |
| test      |           |           |           |           |           |
| spe       |           |           |           |           |           |
| cimen(s), |           |           |           |           |           |
| including |           |           |           |           |           |
| full      |           |           |           |           |           |
| co        |           |           |           |           |           |
| mposition |           |           |           |           |           |
| (e.g.,    |           |           |           |           |           |
| comonomer |           |           |           |           |           |
| co        |           |           |           |           |           |
| mposition |           |           |           |           |           |
| of base   |           |           |           |           |           |
| polymer,  |           |           |           |           |           |
| i         |           |           |           |           |           |
| dentities |           |           |           |           |           |
| and       |           |           |           |           |           |
| conce     |           |           |           |           |           |
| ntrations |           |           |           |           |           |
| of        |           |           |           |           |           |
| ad        |           |           |           |           |           |
| juvants,\ |           |           |           |           |           |
| levels of |           |           |           |           |           |
| residual  |           |           |           |           |           |
| mon       |           |           |           |           |           |
| omer(s)), |           |           |           |           |           |
| d         |           |           |           |           |           |
| imensions |           |           |           |           |           |
| (         |           |           |           |           |           |
| thickness |           |           |           |           |           |
| and       |           |           |           |           |           |
| surface   |           |           |           |           |           |
| area),    |           |           |           |           |           |
| and       |           |           |           |           |           |
| relevant  |           |           |           |           |           |
| base      |           |           |           |           |           |
| polymer   |           |           |           |           |           |
| p         |           |           |           |           |           |
| roperties |           |           |           |           |           |
| (e.g.,    |           |           |           |           |           |
| density,  |           |           |           |           |           |
| Tg, Tm,   |           |           |           |           |           |
| %\        |           |           |           |           |           |
| crysta    |           |           |           |           |           |
| llinity). |           |           |           |           |           |
| Indicate  |           |           |           |           |           |
| whether   |           |           |           |           |           |
| specimens |           |           |           |           |           |
| were      |           |           |           |           |           |
| extracted |           |           |           |           |           |
| by total  |           |           |           |           |           |
| immersion |           |           |           |           |           |
| or        |           |           |           |           |           |
| exposed   |           |           |           |           |           |
| to        |           |           |           |           |           |
| solvent   |           |           |           |           |           |
| on a      |           |           |           |           |           |
| single    |           |           |           |           |           |
| side.     |           |           |           |           |           |
|           |           |           |           |           |           |
| >         |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| Mark (X)  |           |           |           |           |           |
| this box  |           |           |           |           |           |
| if you    |           |           |           |           |           |
| attach a  |           |           |           |           |           |
| con       |           |           |           |           |           |
| tinuation |           |           |           |           |           |
| sheet.    |           |           |           |           |           |
| Enter the |           |           |           |           |           |
| a         |           |           |           |           |           |
| ttachment |           |           |           |           |           |
| name and  |           |           |           |           |           |
| number in |           |           |           |           |           |
| Section   |           |           |           |           |           |
| VI of     |           |           |           |           |           |
| this      |           |           |           |           |           |
| form.     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| b\.       |           |           |           |           |           |
| Identify  |           |           |           |           |           |
| food or   |           |           |           |           |           |
| food      |           |           |           |           |           |
| simulants |           |           |           |           |           |
| employed, |           |           |           |           |           |
| times and |           |           |           |           |           |
| tem       |           |           |           |           |           |
| peratures |           |           |           |           |           |
| of        |           |           |           |           |           |
| ex        |           |           |           |           |           |
| traction, |           |           |           |           |           |
| volume of |           |           |           |           |           |
| simulant  |           |           |           |           |           |
| used per  |           |           |           |           |           |
| ex        |           |           |           |           |           |
| traction, |           |           |           |           |           |
| and food  |           |           |           |           |           |
| s         |           |           |           |           |           |
| timulant\ |           |           |           |           |           |
| volume-to |           |           |           |           |           |
| -specimen |           |           |           |           |           |
| surface   |           |           |           |           |           |
| area      |           |           |           |           |           |
| ratio     |           |           |           |           |           |
| (e.g.,    |           |           |           |           |           |
| 10%       |           |           |           |           |           |
| ethanol,  |           |           |           |           |           |
| c         |           |           |           |           |           |
| onditions |           |           |           |           |           |
| of use A  |           |           |           |           |           |
| \[121°C/2 |           |           |           |           |           |
| h, then   |           |           |           |           |           |
| 40°C/238  |           |           |           |           |           |
| h\], 200  |           |           |           |           |           |
| mL of 10% |           |           |           |           |           |
| ethanol   |           |           |           |           |           |
| solution  |           |           |           |           |           |
| per\      |           |           |           |           |           |
| ex        |           |           |           |           |           |
| traction, |           |           |           |           |           |
| 10        |           |           |           |           |           |
| mL/in²).  |           |           |           |           |           |
| If the    |           |           |           |           |           |
| food      |           |           |           |           |           |
| simulant  |           |           |           |           |           |
| volume-to |           |           |           |           |           |
| -specimen |           |           |           |           |           |
| surface   |           |           |           |           |           |
| area      |           |           |           |           |           |
| ratio is  |           |           |           |           |           |
| less than |           |           |           |           |           |
| 10        |           |           |           |           |           |
| mL/in²,   |           |           |           |           |           |
| provide   |           |           |           |           |           |
| evidence  |           |           |           |           |           |
| (e.g.,    |           |           |           |           |           |
| turbidity |           |           |           |           |           |
| or\       |           |           |           |           |           |
| prec      |           |           |           |           |           |
| ipitation |           |           |           |           |           |
| data)     |           |           |           |           |           |
| showing   |           |           |           |           |           |
| that      |           |           |           |           |           |
| s         |           |           |           |           |           |
| aturation |           |           |           |           |           |
| of the    |           |           |           |           |           |
| food      |           |           |           |           |           |
| simulant  |           |           |           |           |           |
| has not   |           |           |           |           |           |
| occurred. |           |           |           |           |           |
|           |           |           |           |           |           |
| >         |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| Mark (X)  |           |           |           |           |           |
| this box  |           |           |           |           |           |
| if you    |           |           |           |           |           |
| attach a  |           |           |           |           |           |
| con       |           |           |           |           |           |
| tinuation |           |           |           |           |           |
| sheet.    |           |           |           |           |           |
| Enter the |           |           |           |           |           |
| a         |           |           |           |           |           |
| ttachment |           |           |           |           |           |
| name and  |           |           |           |           |           |
| number in |           |           |           |           |           |
| Section   |           |           |           |           |           |
| VI of     |           |           |           |           |           |
| this      |           |           |           |           |           |
| form.     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **Part    |           |           |           |           |           |
| II -      |           |           |           |           |           |
| CHEMISTRY |           |           |           |           |           |
| INFO      |           |           |           |           |           |
| RMATION** |           |           |           |           |           |
| *(co      |           |           |           |           |           |
| ntinued)* |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **SECTION |           |           |           |           |           |
| F -       |           |           |           |           |           |
| MIGRATION |           |           |           |           |           |
| LEVELS IN |           |           |           |           |           |
| FOOD**    |           |           |           |           |           |
| *(co      |           |           |           |           |           |
| ntinued)* |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| c\.       |           |           |           |           |           |
| Summarize |           |           |           |           |           |
| results   |           |           |           |           |           |
| of        |           |           |           |           |           |
| migration |           |           |           |           |           |
| testing   |           |           |           |           |           |
| for each  |           |           |           |           |           |
| test      |           |           |           |           |           |
| specimen. |           |           |           |           |           |
| Give      |           |           |           |           |           |
| i         |           |           |           |           |           |
| ndividual |           |           |           |           |           |
| and       |           |           |           |           |           |
| average   |           |           |           |           |           |
| migration |           |           |           |           |           |
| values    |           |           |           |           |           |
| (mg/in²)  |           |           |           |           |           |
| for all   |           |           |           |           |           |
| analytes  |           |           |           |           |           |
| in each\  |           |           |           |           |           |
| simulant  |           |           |           |           |           |
| at all    |           |           |           |           |           |
| time      |           |           |           |           |           |
| points    |           |           |           |           |           |
| (an       |           |           |           |           |           |
| example   |           |           |           |           |           |
| of how    |           |           |           |           |           |
| the data  |           |           |           |           |           |
| should be |           |           |           |           |           |
| presented |           |           |           |           |           |
| is given  |           |           |           |           |           |
| below).   |           |           |           |           |           |
| In        |           |           |           |           |           |
| addition, |           |           |           |           |           |
| provide   |           |           |           |           |           |
| sample    |           |           |           |           |           |
| cal       |           |           |           |           |           |
| culations |           |           |           |           |           |
| relating  |           |           |           |           |           |
| the\      |           |           |           |           |           |
| ins       |           |           |           |           |           |
| trumental |           |           |           |           |           |
| output to |           |           |           |           |           |
| reported  |           |           |           |           |           |
| migration |           |           |           |           |           |
| values in |           |           |           |           |           |
| mg/in².   |           |           |           |           |           |
| For new   |           |           |           |           |           |
| polymers, |           |           |           |           |           |
| provide a |           |           |           |           |           |
| measure   |           |           |           |           |           |
| of        |           |           |           |           |           |
| oligomer  |           |           |           |           |           |
| migration |           |           |           |           |           |
| and, if   |           |           |           |           |           |
| p         |           |           |           |           |           |
| ossible,\ |           |           |           |           |           |
| cha       |           |           |           |           |           |
| racterize |           |           |           |           |           |
| the       |           |           |           |           |           |
| i         |           |           |           |           |           |
| ndividual |           |           |           |           |           |
| low-      |           |           |           |           |           |
| molecular |           |           |           |           |           |
| weight    |           |           |           |           |           |
| oligomer  |           |           |           |           |           |
| co        |           |           |           |           |           |
| mponents. |           |           |           |           |           |
| *(click   |           |           |           |           |           |
| here for  |           |           |           |           |           |
| example)* |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| ###### S  |           |           |           |           |           |
| UMMARY OF |           |           |           |           |           |
|  MIGRATIO |           |           |           |           |           |
| N TESTING |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **TEST    | **        | **FOOD    | **TEMP    | **MI      | **        |
| SAMPLE**  | MIGRANT** | OR**      | ERATURE** | GRATION** | AVERAGE** |
|           |           |           |           |           |           |
| **FORM    |           | **FOOD**  | **AND     | ***(each  | **MI      |
| ULATION** |           |           | TIME OF** | repl      | GRATION** |
|           |           | **S       |           | icate)*** |           |
|           |           | IMULANT** | **A       |           | **        |
|           |           |           | NALYSIS** |           | *(average |
|           |           |           |           |           | of        |
|           |           |           |           |           | repli     |
|           |           |           |           |           | cates)*** |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **Part    |           |           |           |           |           |
| II -      |           |           |           |           |           |
| CHEMISTRY |           |           |           |           |           |
| INFO      |           |           |           |           |           |
| RMATION** |           |           |           |           |           |
| *(co      |           |           |           |           |           |
| ntinued)* |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **SECTION |           |           |           |           |           |
| F -       |           |           |           |           |           |
| MIGRATION |           |           |           |           |           |
| LEVELS IN |           |           |           |           |           |
| FOOD**    |           |           |           |           |           |
| *(co      |           |           |           |           |           |
| ntinued)* |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| d\.       |           |           |           |           |           |
| Provide a |           |           |           |           |           |
| summary   |           |           |           |           |           |
| of method |           |           |           |           |           |
| v         |           |           |           |           |           |
| alidation |           |           |           |           |           |
| results.  |           |           |           |           |           |
| Give      |           |           |           |           |           |
| average   |           |           |           |           |           |
| percent   |           |           |           |           |           |
| recovery  |           |           |           |           |           |
| for all   |           |           |           |           |           |
| analytes, |           |           |           |           |           |
| food or   |           |           |           |           |           |
| food      |           |           |           |           |           |
| s         |           |           |           |           |           |
| imulants, |           |           |           |           |           |
| and       |           |           |           |           |           |
| fort      |           |           |           |           |           |
| ification |           |           |           |           |           |
| (         |           |           |           |           |           |
| spiking)\ |           |           |           |           |           |
| levels.   |           |           |           |           |           |
| Full      |           |           |           |           |           |
| details,  |           |           |           |           |           |
| including |           |           |           |           |           |
| de        |           |           |           |           |           |
| scription |           |           |           |           |           |
| of        |           |           |           |           |           |
| spiking   |           |           |           |           |           |
| procedure |           |           |           |           |           |
| and       |           |           |           |           |           |
| calc      |           |           |           |           |           |
| ulations, |           |           |           |           |           |
| must be   |           |           |           |           |           |
| included  |           |           |           |           |           |
| as an     |           |           |           |           |           |
| at        |           |           |           |           |           |
| tachment. |           |           |           |           |           |
|           |           |           |           |           |           |
| >         |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| Mark (X)  |           |           |           |           |           |
| this box  |           |           |           |           |           |
| if you    |           |           |           |           |           |
| attach a  |           |           |           |           |           |
| con       |           |           |           |           |           |
| tinuation |           |           |           |           |           |
| sheet.    |           |           |           |           |           |
| Enter the |           |           |           |           |           |
| a         |           |           |           |           |           |
| ttachment |           |           |           |           |           |
| name and  |           |           |           |           |           |
| number in |           |           |           |           |           |
| Section   |           |           |           |           |           |
| VI of     |           |           |           |           |           |
| this      |           |           |           |           |           |
| form.     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **2.      |           |           |           |           |           |
| MIGRATION |           |           |           |           |           |
| CA        |           |           |           |           |           |
| LCULATION |           |           |           |           |           |
| OPTION**  |           |           |           |           |           |
|           |           |           |           |           |           |
| *See      |           |           |           |           |           |
| Chemistry |           |           |           |           |           |
| Recomme   |           |           |           |           |           |
| ndations, |           |           |           |           |           |
| Sections  |           |           |           |           |           |
| II.D. for |           |           |           |           |           |
| di        |           |           |           |           |           |
| scussions |           |           |           |           |           |
| on 100%   |           |           |           |           |           |
| migration |           |           |           |           |           |
| calc      |           |           |           |           |           |
| ulations, |           |           |           |           |           |
| II.D.4    |           |           |           |           |           |
| for       |           |           |           |           |           |
| in        |           |           |           |           |           |
| formation |           |           |           |           |           |
| on FDA's  |           |           |           |           |           |
| migration |           |           |           |           |           |
| d         |           |           |           |           |           |
| atabase,\ |           |           |           |           |           |
| and       |           |           |           |           |           |
| II.D.5    |           |           |           |           |           |
| for       |           |           |           |           |           |
| migration |           |           |           |           |           |
| m         |           |           |           |           |           |
| odeling.* |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| Describe  |           |           |           |           |           |
| the basis |           |           |           |           |           |
| of the    |           |           |           |           |           |
| mat       |           |           |           |           |           |
| hematical |           |           |           |           |           |
| approach  |           |           |           |           |           |
| used in   |           |           |           |           |           |
| e         |           |           |           |           |           |
| stimating |           |           |           |           |           |
| migration |           |           |           |           |           |
| levels to |           |           |           |           |           |
| food for  |           |           |           |           |           |
| the FCS   |           |           |           |           |           |
| or any    |           |           |           |           |           |
| migrants, |           |           |           |           |           |
| such as   |           |           |           |           |           |
| imp       |           |           |           |           |           |
| urities,\ |           |           |           |           |           |
| monomers  |           |           |           |           |           |
| or        |           |           |           |           |           |
| breakdown |           |           |           |           |           |
| products, |           |           |           |           |           |
| in the    |           |           |           |           |           |
| FCS.      |           |           |           |           |           |
| Fully     |           |           |           |           |           |
| describe  |           |           |           |           |           |
| as        |           |           |           |           |           |
| sumptions |           |           |           |           |           |
| made in   |           |           |           |           |           |
| deriving  |           |           |           |           |           |
| the       |           |           |           |           |           |
| estimates |           |           |           |           |           |
| and show  |           |           |           |           |           |
| all       |           |           |           |           |           |
| calc      |           |           |           |           |           |
| ulations. |           |           |           |           |           |
|           |           |           |           |           |           |
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| Mark (X)  |           |           |           |           |           |
| this box  |           |           |           |           |           |
| if you    |           |           |           |           |           |
| attach a  |           |           |           |           |           |
| con       |           |           |           |           |           |
| tinuation |           |           |           |           |           |
| sheet.    |           |           |           |           |           |
| Enter the |           |           |           |           |           |
| a         |           |           |           |           |           |
| ttachment |           |           |           |           |           |
| name and  |           |           |           |           |           |
| number in |           |           |           |           |           |
| Section   |           |           |           |           |           |
| VI of     |           |           |           |           |           |
| this      |           |           |           |           |           |
| form.     |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+

+------------------------+-------+-------+-------+-----------+-------+
| **Part II - CHEMISTRY  |       |       |       |           |       |
| INFORMATION**          |       |       |       |           |       |
| *(continued)*          |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| **SECTION G -          |       |       |       |           |       |
| ESTIMATED DAILY INTAKE |       |       |       |           |       |
| (EDI)**                |       |       |       |           |       |
|                        |       |       |       |           |       |
| *See Chemistry         |       |       |       |           |       |
| Recommendations,       |       |       |       |           |       |
| Sections II.E and      |       |       |       |           |       |
| Appendix IV*           |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| The EDI for the        |       |       |       |           |       |
| notified use must be   |       |       |       |           |       |
| calculated by the      |       |       |       |           |       |
| notifier for both the  |       |       |       |           |       |
| FCS and any migrants.  |       |       |       |           |       |
| The notifier is also   |       |       |       |           |       |
| responsible for        |       |       |       |           |       |
| providing\             |       |       |       |           |       |
| cumulative EDIs        |       |       |       |           |       |
| (CEDIs) reflecting any |       |       |       |           |       |
| previously regulated,  |       |       |       |           |       |
| notified, or otherwise |       |       |       |           |       |
| authorized uses of the |       |       |       |           |       |
| FCS. The notifier may  |       |       |       |           |       |
| wish to consult FDA\   |       |       |       |           |       |
| to obtain this         |       |       |       |           |       |
| information prior to   |       |       |       |           |       |
| submitting a           |       |       |       |           |       |
| notification.          |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| **1. SINGLE-USE        |       |       |       |           |       |
| ARTICLES**             |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| Show representative    |       |       |       |           |       |
| calculations for the   |       |       |       |           |       |
| EDI for all migrants.  |       |       |       |           |       |
| Clearly describe the   |       |       |       |           |       |
| food-type distribution |       |       |       |           |       |
| factors (fT) and       |       |       |       |           |       |
| consumption factors    |       |       |       |           |       |
| (CF)\                  |       |       |       |           |       |
| used in the            |       |       |       |           |       |
| calculations *(see     |       |       |       |           |       |
| Chemistry              |       |       |       |           |       |
| Recommendations        |       |       |       |           |       |
| Appendix IV)*. If fT   |       |       |       |           |       |
| and/or CF values other |       |       |       |           |       |
| than those assigned by |       |       |       |           |       |
| FDA are used,          |       |       |       |           |       |
| information supporting |       |       |       |           |       |
| derivation and use of  |       |       |       |           |       |
| such factors must be   |       |       |       |           |       |
| attached. The          |       |       |       |           |       |
| following general      |       |       |       |           |       |
| equation is used to    |       |       |       |           |       |
| calculate an EDI:      |       |       |       |           |       |
|                        |       |       |       |           |       |
| > EDI = DC x 3 kg      |       |       |       |           |       |
| > food/p/d\            |       |       |       |           |       |
| > = CF x \<M\> x 3 kg  |       |       |       |           |       |
| > food/p/d\            |       |       |       |           |       |
| > = CF x               |       |       |       |           |       |
| > \[(Ma                |       |       |       |           |       |
| q)(faq)+(Mac)(fac)+(Ma |       |       |       |           |       |
| l)(fal)+(Mfat)(ffat)\] |       |       |       |           |       |
| > x 3 kg/p/d           |       |       |       |           |       |
|                        |       |       |       |           |       |
| where: (aq) is         |       |       |       |           |       |
| aqueous, (ac) is       |       |       |       |           |       |
| acidic, (al) is        |       |       |       |           |       |
| alcoholic, and (fat)   |       |       |       |           |       |
| is fatty               |       |       |       |           |       |
|                        |       |       |       |           |       |
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| Mark (X) this box if   |       |       |       |           |       |
| you attach a           |       |       |       |           |       |
| continuation sheet.    |       |       |       |           |       |
| Enter the attachment   |       |       |       |           |       |
| name and number in     |       |       |       |           |       |
| Section VI of this     |       |       |       |           |       |
| form.                  |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| **2. REPEAT-USE        |       |       |       |           |       |
| ARTICLES**             |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| > Using the migration  |       |       |       |           |       |
| > levels to food       |       |       |       |           |       |
| > determined in        |       |       |       |           |       |
| > Section II.F.2 and   |       |       |       |           |       |
| > the use scenario     |       |       |       |           |       |
| > information          |       |       |       |           |       |
| > described in Section |       |       |       |           |       |
| > II.D.2.b, show the\  |       |       |       |           |       |
| > calculations used    |       |       |       |           |       |
| > for determining DC   |       |       |       |           |       |
| > and EDI for the FCS  |       |       |       |           |       |
| > and any migrants.    |       |       |       |           |       |
| >                      |       |       |       |           |       |
| >                      |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| Mark (X) this box if   |       |       |       |           |       |
| you attach a           |       |       |       |           |       |
| continuation sheet.    |       |       |       |           |       |
| Enter the attachment   |       |       |       |           |       |
| name and number in     |       |       |       |           |       |
| Section VI of this     |       |       |       |           |       |
| form.                  |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| **Part II - CHEMISTRY  |       |       |       |           |       |
| INFORMATION**          |       |       |       |           |       |
| *(continued)*          |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| **SECTION G -          |       |       |       |           |       |
| ESTIMATED DAILY INTAKE |       |       |       |           |       |
| (EDI)** *(continued)*  |       |       |       |           |       |
|                        |       |       |       |           |       |
| *See Chemistry         |       |       |       |           |       |
| Recommendations,       |       |       |       |           |       |
| Sections II.E and      |       |       |       |           |       |
| Appendix IV*           |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| **3. SUMMARY OF THE    |       |       |       |           |       |
| CHEMISTRY              |       |       |       |           |       |
| INFORMATION**          |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| Summarize the values   |       |       |       |           |       |
| for weight-average     |       |       |       |           |       |
| migration (\<M\>),     |       |       |       |           |       |
| dietary concentration  |       |       |       |           |       |
| (DC), and EDI for the  |       |       |       |           |       |
| FCS and any migrants,  |       |       |       |           |       |
| including oligomeric\  |       |       |       |           |       |
| species and breakdown  |       |       |       |           |       |
| products, as           |       |       |       |           |       |
| appropriate. Provide   |       |       |       |           |       |
| cumulative EDI (CEDI)  |       |       |       |           |       |
| to include this use,   |       |       |       |           |       |
| where appropriate.     |       |       |       |           |       |
|                        |       |       |       |           |       |
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
| **CHEMICAL NAME**      | **CAS | **\<  | *     | **EDI**   | **    |
|                        | R     | M\>** | *DC** |           | CDC** |
|                        | EG.** |       |       | *         |       |
|                        |       | **(p  | **(p  | *(mg/pers | **(p  |
|                        | **    | pb)** | pb)** | on/day)** | pb)** |
|                        | NO.** |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+
|                        |       |       |       |           |       |
+------------------------+-------+-------+-------+-----------+-------+

+--------------------------------------------------+-------------------+
| **Part III - SAFETY NARRATIVE**                  |                   |
+--------------------------------------------------+-------------------+
| The safety narrative is an executive summary     |                   |
| describing the scientific basis of your          |                   |
| determination that the food contact substance    |                   |
| (FCS) is safe\                                   |                   |
| under the conditions of use requested in this    |                   |
| notification. Your safety narrative should       |                   |
| address any negative information regarding the   |                   |
| safety of the\                                   |                   |
| FCS and its constituents. Your safety narrative  |                   |
| should summarize the chemistry and toxicology    |                   |
| information that justify a conclusion that the   |                   |
| intended\                                        |                   |
| use of the FCS is safe. Your safety narrative    |                   |
| should also address the safety of any mutagenic  |                   |
| or carcinogenic constituents of the FCS. Upper   |                   |
| bound\                                           |                   |
| lifetime cancer risk levels and acceptable daily |                   |
| intake values should be included as appropriate. |                   |
| Instructions are provided in *Guidance for       |                   |
| Industry -\                                      |                   |
| Preparation of Premarket Notifications for Food  |                   |
| Contact Substances: Toxicology Recommendations,  |                   |
| Section VI*. Do not provide detailed study\      |                   |
| summaries in the safety narrative. Such          |                   |
| summaries and supporting documentation should be |                   |
| included in the Comprehensive Toxicology         |                   |
| Profile(s) as\                                   |                   |
| an attachment to this notification *(see         |                   |
| Guidance for Industry - Preparation of Premarket |                   |
| Notification for Food Contact Substances:        |                   |
| Toxicology\                                      |                   |
| Recommendations, Section VII)*.                  |                   |
|                                                  |                   |
|                                                  |                   |
+--------------------------------------------------+-------------------+
| Mark (X) this box if you attach a continuation   |                   |
| sheet. Enter the attachment name and number in   |                   |
| Section VI of this form.                         |                   |
+--------------------------------------------------+-------------------+
| **Part IV - ENVIRONMENTAL INFORMATION (21 CFR    |                   |
| Part 25)**                                       |                   |
+--------------------------------------------------+-------------------+
| All FCN submissions must contain either a claim  |                   |
| of categorical exclusion under 21 CFR 25.32 or   |                   |
| an environmental assessment (EA) under 21 CFR\   |                   |
| 25.40.                                           |                   |
+--------------------------------------------------+-------------------+
| ###### A - CLAIM OF CATEGORICAL EXCLUSION        |                   |
+--------------------------------------------------+-------------------+
| 1\. Cite the specific section(s) of the CFR      |                   |
| under which the categorical exclusion is         |                   |
| claimed:                                         |                   |
|                                                  |                   |
| > **21 CFR 25.32 (i)**                           |                   |
| >                                                |                   |
| > a\. Is the FCS a component of a coating? Yes   |                   |
| > No                                             |                   |
| >                                                |                   |
| > b\. If no, the % of the FCS in the finished    |                   |
| > food-contact article is [     ]{.underline}    |                   |
| > and                                            |                   |
| >                                                |                   |
| > c\. The % of the total market volume that      |                   |
| > remains with the food-contact articles is      |                   |
| > [     ]{.underline}                            |                   |
| >                                                |                   |
| > **21 CFR 25.32 (j)**                           |                   |
| >                                                |                   |
| > Is the FCS a component of a:                   |                   |
| >                                                |                   |
| > a\. Repeat-use article? Yes No                 |                   |
| >                                                |                   |
| > b\. Permanent or semi-permanent food-contact   |                   |
| > surface? Yes No                                |                   |
| >                                                |                   |
| > **21 CFR 25.32 (k)**                           |                   |
| >                                                |                   |
| > **21 CFR 25.32 (q)**                           |                   |
| >                                                |                   |
| > a\. Is current FIFRA label attached? Yes No    |                   |
| >                                                |                   |
| > b\. Is the requested use essentially the same  |                   |
| > as the label? Yes No                           |                   |
| >                                                |                   |
| > If current FIFRA label has limitation on       |                   |
| > food-contact uses, provide a draft copy of a   |                   |
| > revised label you intend to submit to EPA to   |                   |
| > include\                                       |                   |
| > food-contact uses.                             |                   |
| >                                                |                   |
| > 21 CFR 25.32 (r)                               |                   |
+--------------------------------------------------+-------------------+
| 2\. Does your proposed food-contact use comply   |                   |
| with the categorical exclusion criteria?\        |                   |
| If no, go to section B below. Yes No             |                   |
+--------------------------------------------------+-------------------+
| 3\. To the best of your knowledge, are there any |                   |
| extraordinary circumstances that would require   |                   |
| your submission of an EA? *(see 21 CFR 25.21)\   |                   |
| *If yes, go to section B below.. Yes No          |                   |
+--------------------------------------------------+-------------------+
| **B - ENVIRONMENTAL ASSESSMENT**                 |                   |
|                                                  |                   |
| *See Environmental Recommendations*              |                   |
+--------------------------------------------------+-------------------+
| 1\. If an EA is required, state that an EA has   |                   |
| been prepared under 21 CFR 25.40, and is         |                   |
| attached.                                        |                   |
|                                                  |                   |
| 2\. Environmental assessments are public         |                   |
| documents and should not contain confidential    |                   |
| information. Such information should be included |                   |
| in a\                                            |                   |
| separate section of the FCN, labeled             |                   |
| confidential and summarized to the extent        |                   |
| possible in the EA.                              |                   |
|                                                  |                   |
| >                                                |                   |
+--------------------------------------------------+-------------------+
| **Part V - CERTIFICATION**                       |                   |
+--------------------------------------------------+-------------------+
| > The accuracy of the statements you make in     |                   |
| > this notice should reflect your best           |                   |
| > prediction of the anticipated facts regarding  |                   |
| > the chemical\                                  |                   |
| > substance described herein. Any knowing and    |                   |
| > willful misinterpretation is subject to        |                   |
| > criminal penalty pursuant to 18 U.S.C. 1001.   |                   |
| >                                                |                   |
| > The notifying party certifies that the         |                   |
| > information provided herein is accurate and    |                   |
| > complete to the best of his/her knowledge.     |                   |
+--------------------------------------------------+-------------------+
| SIGNATURE OF AUTHORIZED OFFICIAL OR AGENT        |                   |
+--------------------------------------------------+-------------------+
| TITLE                                            | DATE              |
|                                                  |                   |
|                                                  |                   |
+--------------------------------------------------+-------------------+

+---------------------------------------------+------------------------+
| **Part VI - LIST OF ATTACHMENT**            |                        |
+---------------------------------------------+------------------------+
| Attach continuation sheets for sections of  |                        |
| the form and test data and other data       |                        |
| (including physical/chemical properties and |                        |
| structure/activity\                         |                        |
| information), and optional information      |                        |
| after this page. Clearly identify the       |                        |
| attachment and the section of the form to   |                        |
| which it relates, as appropriate.\          |                        |
| Number consecutively the pages of the       |                        |
| attachments. In the column below, enter the |                        |
| inclusive page numbers of each attachment.  |                        |
+---------------------------------------------+------------------------+
| **ATTACHMENT NAME**                         | **ATTACHMENT**         |
|                                             |                        |
|                                             | **PAGE NUMBER(S)**     |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
| Mark (X) this box if you attach a           |                        |
| continuation sheet. Enter the attachment    |                        |
| name and number in Section VI of this form. |                        |
+---------------------------------------------+------------------------+

+-----------+-----------+-----------+-----------+-----------+-----------+
| **LIST OF |           |           |           |           |           |
| E         |           |           |           |           |           |
| XAMPLES** |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 2\. a.    |           |           |           |           |           |
| For       |           |           |           |           |           |
| s         |           |           |           |           |           |
| ingle-use |           |           |           |           |           |
| articles, |           |           |           |           |           |
| list the  |           |           |           |           |           |
| food      |           |           |           |           |           |
| types     |           |           |           |           |           |
| expected  |           |           |           |           |           |
| to        |           |           |           |           |           |
| contact   |           |           |           |           |           |
| the FCS,  |           |           |           |           |           |
| with      |           |           |           |           |           |
| examples  |           |           |           |           |           |
| if known. |           |           |           |           |           |
| Refer to  |           |           |           |           |           |
| the food  |           |           |           |           |           |
| type      |           |           |           |           |           |
| classi    |           |           |           |           |           |
| fications |           |           |           |           |           |
| in\       |           |           |           |           |           |
| chemistry |           |           |           |           |           |
| guidance, |           |           |           |           |           |
| when      |           |           |           |           |           |
| possible. |           |           |           |           |           |
| Also      |           |           |           |           |           |
| provide   |           |           |           |           |           |
| maximum   |           |           |           |           |           |
| tem       |           |           |           |           |           |
| peratures |           |           |           |           |           |
| and times |           |           |           |           |           |
| of food   |           |           |           |           |           |
| contact,  |           |           |           |           |           |
| referring |           |           |           |           |           |
| to the    |           |           |           |           |           |
| c         |           |           |           |           |           |
| onditions |           |           |           |           |           |
| of use in |           |           |           |           |           |
| c         |           |           |           |           |           |
| hemistry\ |           |           |           |           |           |
| guidance, |           |           |           |           |           |
| when      |           |           |           |           |           |
| possible. |           |           |           |           |           |
|           |           |           |           |           |           |
| > **E     |           |           |           |           |           |
| xample:** |           |           |           |           |           |
| > A       |           |           |           |           |           |
| >         |           |           |           |           |           |
|  notifier |           |           |           |           |           |
| > wishes  |           |           |           |           |           |
| > to      |           |           |           |           |           |
| > obtain  |           |           |           |           |           |
| >         |           |           |           |           |           |
|  approval |           |           |           |           |           |
| > for the |           |           |           |           |           |
| > use of  |           |           |           |           |           |
| > a       |           |           |           |           |           |
| > polymer |           |           |           |           |           |
| >         |           |           |           |           |           |
| adjuvant, |           |           |           |           |           |
| >         |           |           |           |           |           |
|  Adjuvant |           |           |           |           |           |
| > Y, in   |           |           |           |           |           |
| > two     |           |           |           |           |           |
| >         |           |           |           |           |           |
|  specific |           |           |           |           |           |
| > olefin  |           |           |           |           |           |
| >         |           |           |           |           |           |
|  polymers |           |           |           |           |           |
| > for use |           |           |           |           |           |
| > with    |           |           |           |           |           |
| > d       |           |           |           |           |           |
| ifferent\ |           |           |           |           |           |
| > food    |           |           |           |           |           |
| > Types   |           |           |           |           |           |
| > (see    |           |           |           |           |           |
| >         |           |           |           |           |           |
| chemistry |           |           |           |           |           |
| >         |           |           |           |           |           |
| guidance) |           |           |           |           |           |
| > under   |           |           |           |           |           |
| >         |           |           |           |           |           |
| different |           |           |           |           |           |
| > C       |           |           |           |           |           |
| onditions |           |           |           |           |           |
| > of Use  |           |           |           |           |           |
| > (see    |           |           |           |           |           |
| >         |           |           |           |           |           |
| chemistry |           |           |           |           |           |
| > g       |           |           |           |           |           |
| uidance). |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **USE**   |           | **FOOD    |           | **        |           |
|           |           | TYPE**    |           | CONDITION |           |
|           |           |           |           | OF USE**  |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| >         |           | >         |           | > A       |           |
|  Adjuvant |           |  Aqueous, |           | > through |           |
| > Y used  |           | > Acidic  |           | > H       |           |
| > in HDPE |           | > and     |           | >         |           |
| > at      |           | > Low-    |           | >         |           |
| > levels  |           | > A       |           |           |           |
| > not\    |           | lcoholic\ |           |           |           |
| >         |           | > (Types  |           |           |           |
| exceeding |           | > I, II,  |           |           |           |
| > 0.3     |           | > IVB,    |           |           |           |
| > wt.% of |           | > VIA,    |           |           |           |
| > the     |           | > VIB and |           |           |           |
| >         |           | > VIIB)   |           |           |           |
| finished\ |           | >         |           |           |           |
| > polymer |           | >         |           |           |           |
| >         |           |           |           |           |           |
| >         |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| >         |           | > Fatty   |           | > C       |           |
|  Adjuvant |           | > Foods   |           | > through |           |
| > Y used  |           | > (Types  |           | > G       |           |
| > in PP   |           | > III,    |           | >         |           |
| > at      |           | > IVA, V, |           | >         |           |
| > levels  |           | > VIIA,   |           |           |           |
| > not\    |           | > IX)\    |           |           |           |
| >         |           | >         |           |           |           |
| exceeding |           |           |           |           |           |
| > 0.2     |           |           |           |           |           |
| > wt.% of |           |           |           |           |           |
| > the     |           |           |           |           |           |
| >         |           |           |           |           |           |
| finished\ |           |           |           |           |           |
| > polymer |           |           |           |           |           |
| >         |           |           |           |           |           |
| >         |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| c\.       |           |           |           |           |           |
| Summarize |           |           |           |           |           |
| results   |           |           |           |           |           |
| of        |           |           |           |           |           |
| migration |           |           |           |           |           |
| testing   |           |           |           |           |           |
| for each  |           |           |           |           |           |
| test      |           |           |           |           |           |
| specimen. |           |           |           |           |           |
| Give      |           |           |           |           |           |
| i         |           |           |           |           |           |
| ndividual |           |           |           |           |           |
| and       |           |           |           |           |           |
| average   |           |           |           |           |           |
| migration |           |           |           |           |           |
| values    |           |           |           |           |           |
| (mg/in²)  |           |           |           |           |           |
| for all   |           |           |           |           |           |
| analytes  |           |           |           |           |           |
| in each\  |           |           |           |           |           |
| simulant  |           |           |           |           |           |
| at all    |           |           |           |           |           |
| time      |           |           |           |           |           |
| points    |           |           |           |           |           |
| (an       |           |           |           |           |           |
| example   |           |           |           |           |           |
| of how    |           |           |           |           |           |
| the data  |           |           |           |           |           |
| should be |           |           |           |           |           |
| presented |           |           |           |           |           |
| is given  |           |           |           |           |           |
| below).   |           |           |           |           |           |
| In        |           |           |           |           |           |
| addition, |           |           |           |           |           |
| provide   |           |           |           |           |           |
| sample    |           |           |           |           |           |
| cal       |           |           |           |           |           |
| culations |           |           |           |           |           |
| relating  |           |           |           |           |           |
| the\      |           |           |           |           |           |
| ins       |           |           |           |           |           |
| trumental |           |           |           |           |           |
| output to |           |           |           |           |           |
| reported  |           |           |           |           |           |
| migration |           |           |           |           |           |
| values in |           |           |           |           |           |
| mg/in².   |           |           |           |           |           |
| For new   |           |           |           |           |           |
| polymers, |           |           |           |           |           |
| provide a |           |           |           |           |           |
| measure   |           |           |           |           |           |
| of        |           |           |           |           |           |
| oligomer  |           |           |           |           |           |
| migration |           |           |           |           |           |
| and, if   |           |           |           |           |           |
| p         |           |           |           |           |           |
| ossible,\ |           |           |           |           |           |
| cha       |           |           |           |           |           |
| racterize |           |           |           |           |           |
| the       |           |           |           |           |           |
| i         |           |           |           |           |           |
| ndividual |           |           |           |           |           |
| low-      |           |           |           |           |           |
| molecular |           |           |           |           |           |
| weight    |           |           |           |           |           |
| oligomer  |           |           |           |           |           |
| co        |           |           |           |           |           |
| mponents. |           |           |           |           |           |
|           |           |           |           |           |           |
| **E       |           |           |           |           |           |
| xample:** |           |           |           |           |           |
| A         |           |           |           |           |           |
| notifier  |           |           |           |           |           |
| conducted |           |           |           |           |           |
| a         |           |           |           |           |           |
| migration |           |           |           |           |           |
| study to  |           |           |           |           |           |
| support   |           |           |           |           |           |
| the use   |           |           |           |           |           |
| of a      |           |           |           |           |           |
| polymer   |           |           |           |           |           |
| adjuvant, |           |           |           |           |           |
| Adjuvant  |           |           |           |           |           |
| X,        |           |           |           |           |           |
| intended  |           |           |           |           |           |
| for use   |           |           |           |           |           |
| at a      |           |           |           |           |           |
| maximum   |           |           |           |           |           |
| level of\ |           |           |           |           |           |
| 0.01 wt.% |           |           |           |           |           |
| in LDPE.  |           |           |           |           |           |
| The       |           |           |           |           |           |
| example   |           |           |           |           |           |
| table     |           |           |           |           |           |
| below     |           |           |           |           |           |
| shows how |           |           |           |           |           |
| the       |           |           |           |           |           |
| notifier  |           |           |           |           |           |
| might     |           |           |           |           |           |
| tabulate  |           |           |           |           |           |
| migration |           |           |           |           |           |
| data      |           |           |           |           |           |
| obtained  |           |           |           |           |           |
| from      |           |           |           |           |           |
| sample    |           |           |           |           |           |
| plaques\  |           |           |           |           |           |
| tested in |           |           |           |           |           |
| 10%       |           |           |           |           |           |
| ethanol   |           |           |           |           |           |
| under     |           |           |           |           |           |
| c         |           |           |           |           |           |
| onditions |           |           |           |           |           |
| of use B. |           |           |           |           |           |
|           |           |           |           |           |           |
| ###### S  |           |           |           |           |           |
| UMMARY OF |           |           |           |           |           |
|  MIGRATIO |           |           |           |           |           |
| N TESTING |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| **TEST    | **        | **FOOD    | **TEMP    | **MI      | **        |
| SAMPLE**  | MIGRANT** | OR**      | ERATURE** | GRATION** | AVERAGE** |
|           |           |           |           |           |           |
| **FORM    |           | **FOOD**  | **AND     | *(each    | **MI      |
| ULATION** |           |           | TIME OF** | re        | GRATION** |
|           |           | **S       |           | plicate)* |           |
|           |           | IMULANT** | **A       |           | *(average |
|           |           |           | NALYSIS** |           | of        |
|           |           |           |           |           | rep       |
|           |           |           |           |           | licates)* |
+-----------+-----------+-----------+-----------+-----------+-----------+
| LDPE      | Adjuvant\ | 10%\      | 100°C\    | 0.012     | 0.015     |
| co        | X         | ethanol   | analysis  | mg/in²\   | mg/in²    |
| ntaining\ |           |           | after\    | 0.011     |           |
| 0.01 wt.% |           |           | 2 hours   | mg/in²\   |           |
| of\       |           |           |           | 0.021     |           |
| Adjuvant  |           |           |           | mg/in²    |           |
| X         |           |           |           |           |           |
|           |           |           |           |           |           |
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           | 40°C\     | 0.015     | 0.017     |
|           |           |           | analysis  | mg/in²\   | mg/in²\   |
|           |           |           | after\    | 0.014     |           |
|           |           |           | 24 hours\ | mg/in²\   |           |
|           |           |           |           | 0.022     |           |
|           |           |           |           | mg/in²\   |           |
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           | 40°C\     | 0.017     | 0.019     |
|           |           |           | analysis  | mg/in²\   | mg/in²\   |
|           |           |           | after\    | 0.017     |           |
|           |           |           | 96 hours\ | mg/in²\   |           |
|           |           |           |           | 0.023     |           |
|           |           |           |           | mg/in²\   |           |
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
|           |           |           | 100°C\    | 0.020     | 0.021     |
|           |           |           | analysis  | mg/in²\   | mg/in²\   |
|           |           |           | after\    | 0.021     |           |
|           |           |           | 240       | mg/in²\   |           |
|           |           |           | hours\    | 0.023     |           |
|           |           |           |           | mg/in²\   |           |
|           |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 3, no. 5)*  |
+-----------------------------------------------------------------------+
| 5\. Description                                                       |
|                                                                       |
| > Provide a description of the FCS, including chemical formula(e),    |
| > structure(s) and molecular weight(s). For FCSs that cannot be       |
| > represented by a\                                                   |
| > discrete chemical structure, such as new polymers, provide a        |
| > representative chemical structure(s) and the Mw and Mn. For new     |
| > copolymers,\                                                        |
| > also provide the ratio of monomer units in the copolymer.           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 3, no. 6)*  |
+-----------------------------------------------------------------------+
| 6\. Characterization                                                  |
|                                                                       |
| > Attach data, such as infrared (IR), ultraviolet (UV), nuclear       |
| > magnetic resonance (NMR), mass spectra, or other similar data for   |
| > identification of\                                                  |
| > the FCS.                                                            |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 4, no. 2)*  |
+-----------------------------------------------------------------------+
| 2\. Describe the manufacturing process, including reaction conditions |
| (e.g., times and temperatures), and include chemical equations and\   |
| stoichiometry for all synthetic steps and side reactions. Describe    |
| any purification steps.                                               |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 5, no. 3)*  |
+-----------------------------------------------------------------------+
| ^†^ If yes, ensure that exposures to these substances are addressed   |
| in Section II.G of this form. If no, provide an explanation below.    |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 7, item b)* |
+-----------------------------------------------------------------------+
| b\. Molecular Weight Profile of the FCS                               |
|                                                                       |
| > Provide a value for the maximum percentage of oligomeric species    |
| > (not including residual monomers, reactants, or solvents) below     |
| > 1000\                                                               |
| > Daltons and include supporting data and analytical methods.         |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 7, no. 1)*  |
+-----------------------------------------------------------------------+
| 1\. Describe the intended use of the FCS. Include maximum use         |
| level(s) in food-contact materials, types of food-contact articles    |
| with or in which the\                                                 |
| FCS is expected to be used (e.g., films, coatings, molded articles)   |
| and maximum thickness, as applicable. Indicate whether single or      |
| repeat use\                                                           |
| (or both) is intended:                                                |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 8, item b)* |
+-----------------------------------------------------------------------+
| b\. For repeat-use articles, provide a typical use scenario. Include  |
| the highest intended use temperature, maximum food-contact time for   |
| the article, and typical amount of food contacted over the service    |
| lifetime of the article.                                              |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 9, no. 3)*  |
+-----------------------------------------------------------------------+
| 3\. State the intended technical effect of the FCS. Summarize data    |
| demonstrating that the FCS will achieve the intended technical        |
| effect.\                                                              |
| Specifically address the minimum amount required to achieve the       |
| intended technical effect. Include data as an attachment.             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 9, Section  |
| E - Stability Data, no. 1)*                                           |
+-----------------------------------------------------------------------+
| 1\. Describe any degradation, decomposition or other chemical         |
| breakdown process (oxidation, photolysis, hydrolysis, etc.) that the  |
| FCS may\                                                              |
| undergo during either its intended use in the manufacture of a        |
| food-contact article or during migration testing (if performed) of a  |
| test plaque\                                                          |
| containing the FCS. If no degradation is expected, so state.          |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

  -------------------- -------------- ------------------- ----------------
  **Part II -                                             
  CHEMISTRY                                               
  INFORMATION**                                           
  *(continued)*                                           

  2\. List the                                            
  breakdown products                                      
  for the FCS and                                         
  provide CAS names,                                      
  CAS Reg. Nos., and                                      
  structures, as                                          
  appropriate. Address                                    
  the amount of any\                                      
  breakdown products                                      
  that migrate to food                                    
  and ensure that                                         
  exposures to these                                      
  substances are                                          
  addressed in Section                                    
  II.G of this form.                                      

  **SUBSTANCE NAME**   **CAS REG.     **SUBSTANCE NAME**  **CAS REG. NO.**
                       NO.**                              

                                                               

  **STRUCTURE**                       **STRUCTURE**       

                                                          

  **SUBSTANCE NAME**   **CAS REG.     **SUBSTANCE NAME**  **CAS REG. NO.**
                       NO.**                              

                                                               

  **STRUCTURE**                       **STRUCTURE**       

                                                          

  Mark (X) this box if                                    
  you attach a                                            
  continuation sheet.                                     
  Enter the attachment                                    
  name and number in                                      
  Section VI of this                                      
  form.                                                   
  -------------------- -------------- ------------------- ----------------

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 11, item    |
| a)*                                                                   |
+-----------------------------------------------------------------------+
| a\. Describe test specimen(s), including full composition (e.g.,      |
| comonomer composition of base polymer, identities and concentrations  |
| of adjuvants,\                                                        |
| levels of residual monomer(s)), dimensions (thickness and surface     |
| area), and relevant base polymer properties (e.g., density, Tg, Tm,   |
| %\                                                                    |
| crystallinity). Indicate whether specimens were extracted by total    |
| immersion or exposed to solvent on a single side.                     |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 11, item    |
| b)*                                                                   |
+-----------------------------------------------------------------------+
| b\. Identify food or food simulants employed, times and temperatures  |
| of extraction, volume of simulant used per extraction, and food       |
| stimulant\                                                            |
| volume-to-specimen surface area ratio (e.g, 10% ethanol, conditions   |
| of use A \[121°C/2 h, then 40°C/238 h\], 200 mL of 10% ethanol        |
| solution per\                                                         |
| extraction, 10 mL/in²). If the food simulant volume-to-specimen       |
| surface area ratio is less than 10 mL/in², provide evidence (e.g.,    |
| turbidity or\                                                         |
| precipitation data) showing that saturation of the food simulant has  |
| not occurred.                                                         |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 13, item    |
| d)*                                                                   |
+-----------------------------------------------------------------------+
| d\. Provide a summary of method validation results. Give average      |
| percent recovery for all analytes, food or food simulants, and        |
| fortification (spiking)\                                              |
| levels. Full details, including description of spiking procedure and  |
| calculations, must be included as an attachment.                      |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 13, no 2.   |
| Migration Calculation Option)*                                        |
+-----------------------------------------------------------------------+
| Describe the basis of the mathematical approach used in estimating    |
| migration levels to food for the FCS or any migrants, such as         |
| impurities,\                                                          |
| monomers or breakdown products, in the FCS. Fully describe            |
| assumptions made in deriving the estimates and show all calculations. |
|                                                                       |
|                                                                       |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 14, no 1.   |
| Single-Use Articles)*                                                 |
+-----------------------------------------------------------------------+
| Show representative calculations for the EDI for all migrants.        |
| Clearly describe the food-type distribution factors (f ) and          |
| consumption factors (CF)\                                             |
| used in the calculations *(see Chemistry Recommendations Appendix     |
| IV)*. If f and/or CF values other than those assigned by FDA are      |
| used,\                                                                |
| information supporting derivation and use of such factors must be     |
| attached. The following general equation is used to calculate an EDI: |
|                                                                       |
| > EDI = DC x 3 kg food/p/d\                                           |
| > = CF x \<M\> x 3 kg food/p/d\                                       |
| > = CF x \[(Maq)(faq)+(Mac)(fac)+(Mal)(fal)+(Mfat)(ffat)\] x 3 kg/p/d |
| >                                                                     |
| > where: (aq) is aqueous, (ac) is acidic, (al) is alcoholic, and      |
| > (fat) is fatty                                                      |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part II - CHEMISTRY INFORMATION** *(continued from page 14, no 2.   |
| Repeat-Use Articles)*                                                 |
+-----------------------------------------------------------------------+
| > Using the migration levels to food determined in Section II.F.2 and |
| > the use scenario information described in Section II.D.2.b, show    |
| > the\                                                                |
| > calculations used for determining DC and EDI for the FCS and any    |
| > migrants.                                                           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Part III - SAFETY NARRATIVE** *(continued from page 16)*            |
+-----------------------------------------------------------------------+
| > Using the migration levels to food determined in Section II.F.2 and |
| > the use scenario information described in Section II.D.2.b, show    |
| > the\                                                                |
| > calculations used for determining DC and EDI for the FCS and any    |
| > migrants.                                                           |
| >                                                                     |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section VI of this form.                |
+-----------------------------------------------------------------------+

+---------------------------------------------+------------------------+
| **Part VI - LIST OF ATTACHMENT**            |                        |
+---------------------------------------------+------------------------+
| Attach continuation sheets for sections of  |                        |
| the form and test data and other data       |                        |
| (including physical/chemical properties and |                        |
| structure/activity\                         |                        |
| information), and optional information      |                        |
| after this page. Clearly identify the       |                        |
| attachment and the section of the form to   |                        |
| which it relates, as appropriate.\          |                        |
| Number consecutively the pages of the       |                        |
| attachments. In the column below, enter the |                        |
| inclusive page numbers of each attachment.  |                        |
+---------------------------------------------+------------------------+
| **ATTACHMENT NAME**                         | **ATTACHMENT**         |
|                                             |                        |
|                                             | **PAGE NUMBER(S)**     |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
|                                             |                        |
+---------------------------------------------+------------------------+
| Mark (X) this box if you attach a           |                        |
| continuation sheet. Enter the attachment    |                        |
| name and number in Section VI of this form. |                        |
+---------------------------------------------+------------------------+