+---------+------------------------+-----------------------------------+
| Form    |                        |                                   |
| Ap      |                        |                                   |
| proved: |                        |                                   |
| OMB No. |                        |                                   |
| 091     |                        |                                   |
| 0-0495, |                        |                                   |
| A       |                        |                                   |
| pproval |                        |                                   |
| E       |                        |                                   |
| xpires: |                        |                                   |
| D       |                        |                                   |
| ecember |                        |                                   |
| 31,     |                        |                                   |
| 2008    |                        |                                   |
+---------+------------------------+-----------------------------------+
| Dep     |                        | **AGENCY USE ONLY**               |
| artment |                        |                                   |
| of      |                        |                                   |
| Health  |                        |                                   |
| and     |                        |                                   |
| Human   |                        |                                   |
| S       |                        |                                   |
| ervices |                        |                                   |
|         |                        |                                   |
| Food    |                        |                                   |
| and     |                        |                                   |
| Drug    |                        |                                   |
| Adminis |                        |                                   |
| tration |                        |                                   |
|         |                        |                                   |
| **NOTIF |                        |                                   |
| ICATION |                        |                                   |
| FOR A   |                        |                                   |
| FOOD    |                        |                                   |
| CO      |                        |                                   |
| NTACT** |                        |                                   |
|         |                        |                                   |
| **SU    |                        |                                   |
| BSTANCE |                        |                                   |
| FORMUL  |                        |                                   |
| ATION** |                        |                                   |
|         |                        |                                   |
| NOT FOR |                        |                                   |
| NEW     |                        |                                   |
| USES OF |                        |                                   |
| FOOD    |                        |                                   |
| CONTACT |                        |                                   |
| SUB     |                        |                                   |
| STANCES |                        |                                   |
+---------+------------------------+-----------------------------------+
|         |                        | DATE OF RECEIPT                   |
|         |                        |                                   |
|         |                        |                                   |
+---------+------------------------+-----------------------------------+
|         |                        |                                   |
+---------+------------------------+-----------------------------------+
| **When  | NOTIFICATION CONTROL   |                                   |
| com     | ASSISTANT              |                                   |
| pleted\ |                        |                                   |
| send    | OFFICE OF FOOD         |                                   |
| the     | ADDITIVE SAFETY        |                                   |
| form    |                        |                                   |
| and\    | HFS-275                |                                   |
| notif   |                        |                                   |
| ication | 5100 PAINT BRANCH      |                                   |
| to:**   | PARKWAY                |                                   |
|         |                        |                                   |
|         | COLLEGE PARK, MD       |                                   |
|         | 20740-3835             |                                   |
+---------+------------------------+-----------------------------------+
|         |                        |                                   |
+---------+------------------------+-----------------------------------+
|         |                        |                                   |
+---------+------------------------+-----------------------------------+
| Enter   |                        |                                   |
| the     |                        |                                   |
| total   |                        |                                   |
| number  |                        |                                   |
| of      |                        |                                   |
| pages\  |                        |                                   |
| in the  |                        |                                   |
| Form    |                        |                                   |
| ulation |                        |                                   |
| Notifi  |                        |                                   |
| cation: |                        |                                   |
|         |                        |                                   |
+---------+------------------------+-----------------------------------+
| **      |                        |                                   |
| GENERAL |                        |                                   |
| INSTR   |                        |                                   |
| UCTIONS |                        |                                   |
| FCF -   |                        |                                   |
|         |                        |                                   |
|  **     |                        |                                   |
|         |                        |                                   |
| -       |                        |                                   |
|    This |                        |                                   |
|         |                        |                                   |
|    form |                        |                                   |
|     is  |                        |                                   |
|     i   |                        |                                   |
| ntended |                        |                                   |
|     for |                        |                                   |
|     use |                        |                                   |
|         |                        |                                   |
|    only |                        |                                   |
|     to  |                        |                                   |
|     as  |                        |                                   |
| certain |                        |                                   |
|         |                        |                                   |
|    that |                        |                                   |
|     all |                        |                                   |
|     com |                        |                                   |
| ponents |                        |                                   |
|     of  |                        |                                   |
|     a   |                        |                                   |
|         |                        |                                   |
|    food |                        |                                   |
|         |                        |                                   |
| contact |                        |                                   |
|     su  |                        |                                   |
| bstance |                        |                                   |
|         |                        |                                   |
|    form |                        |                                   |
| ulation |                        |                                   |
|     may |                        |                                   |
|     be  |                        |                                   |
|     l   |                        |                                   |
| egally\ |                        |                                   |
|     m   |                        |                                   |
| arketed |                        |                                   |
|     for |                        |                                   |
|         |                        |                                   |
|   their |                        |                                   |
|     i   |                        |                                   |
| ntended |                        |                                   |
|         |                        |                                   |
|    use. |                        |                                   |
|         |                        |                                   |
| -       |                        |                                   |
|    This |                        |                                   |
|         |                        |                                   |
|    form |                        |                                   |
|     may |                        |                                   |
|     not |                        |                                   |
|     be  |                        |                                   |
|         |                        |                                   |
|    used |                        |                                   |
|     to  |                        |                                   |
|         |                        |                                   |
| request |                        |                                   |
|         |                        |                                   |
|  author |                        |                                   |
| ization |                        |                                   |
|     for |                        |                                   |
|     a   |                        |                                   |
|     new |                        |                                   |
|     use |                        |                                   |
|     of  |                        |                                   |
|     a   |                        |                                   |
|         |                        |                                   |
|    food |                        |                                   |
|         |                        |                                   |
| contact |                        |                                   |
|     su  |                        |                                   |
| bstance |                        |                                   |
|         |                        |                                   |
|   under |                        |                                   |
|         |                        |                                   |
| section |                        |                                   |
|         |                        |                                   |
|  409(h) |                        |                                   |
|     of  |                        |                                   |
|         |                        |                                   |
|    the\ |                        |                                   |
|         |                        |                                   |
| Federal |                        |                                   |
|         |                        |                                   |
|   Food, |                        |                                   |
|         |                        |                                   |
|   Drug, |                        |                                   |
|     and |                        |                                   |
|     C   |                        |                                   |
| osmetic |                        |                                   |
|         |                        |                                   |
|    Act. |                        |                                   |
|     New |                        |                                   |
|         |                        |                                   |
|    uses |                        |                                   |
|     of  |                        |                                   |
|         |                        |                                   |
|    food |                        |                                   |
|         |                        |                                   |
| contact |                        |                                   |
|     usb |                        |                                   |
| stances |                        |                                   |
|         |                        |                                   |
|    must |                        |                                   |
|     be  |                        |                                   |
|     the |                        |                                   |
|         |                        |                                   |
| subject |                        |                                   |
|     of  |                        |                                   |
|     a   |                        |                                   |
|         |                        |                                   |
|   notif |                        |                                   |
| ication |                        |                                   |
|         |                        |                                   |
|  under\ |                        |                                   |
|         |                        |                                   |
| section |                        |                                   |
|         |                        |                                   |
|  409(h) |                        |                                   |
|     in  |                        |                                   |
| cluding |                        |                                   |
|     an  |                        |                                   |
|     FDA |                        |                                   |
|         |                        |                                   |
|    Form |                        |                                   |
|         |                        |                                   |
|   3480. |                        |                                   |
|         |                        |                                   |
| -   You |                        |                                   |
|         |                        |                                   |
|  should |                        |                                   |
|         |                        |                                   |
| include |                        |                                   |
|     all |                        |                                   |
|         |                        |                                   |
|    info |                        |                                   |
| rmation |                        |                                   |
|     ne  |                        |                                   |
| cessary |                        |                                   |
|     to  |                        |                                   |
|     as  |                        |                                   |
| certain |                        |                                   |
|         |                        |                                   |
|    that |                        |                                   |
|         |                        |                                   |
|    each |                        |                                   |
|     co  |                        |                                   |
| mponent |                        |                                   |
|     of  |                        |                                   |
|     the |                        |                                   |
|         |                        |                                   |
|    form |                        |                                   |
| ulation |                        |                                   |
|     may |                        |                                   |
|     be  |                        |                                   |
|         |                        |                                   |
| legally |                        |                                   |
|     ma  |                        |                                   |
| rketed\ |                        |                                   |
|     for |                        |                                   |
|     its |                        |                                   |
|     i   |                        |                                   |
| ntended |                        |                                   |
|     use |                        |                                   |
|     (te |                        |                                   |
| chnical |                        |                                   |
|     e   |                        |                                   |
| ffect). |                        |                                   |
|     For |                        |                                   |
|     e   |                        |                                   |
| xample, |                        |                                   |
|     if  |                        |                                   |
|     the |                        |                                   |
|         |                        |                                   |
|   basis |                        |                                   |
|     for |                        |                                   |
|     com |                        |                                   |
| pliance |                        |                                   |
|     is  |                        |                                   |
|     an  |                        |                                   |
|     ef  |                        |                                   |
| fective |                        |                                   |
|         |                        |                                   |
|  notifi |                        |                                   |
| cation, |                        |                                   |
|     you |                        |                                   |
|         |                        |                                   |
| should\ |                        |                                   |
|         |                        |                                   |
| provide |                        |                                   |
|         |                        |                                   |
|    info |                        |                                   |
| rmation |                        |                                   |
|         |                        |                                   |
|   estab |                        |                                   |
| lishing |                        |                                   |
|         |                        |                                   |
|    that |                        |                                   |
|     you |                        |                                   |
|     may |                        |                                   |
|         |                        |                                   |
|    rely |                        |                                   |
|     on  |                        |                                   |
|         |                        |                                   |
|    that |                        |                                   |
|         |                        |                                   |
|  notifi |                        |                                   |
| cation. |                        |                                   |
+---------+------------------------+-----------------------------------+
| >       |                        | > substance formulation will      |
|  **Part |                        | > contact in its intended use. If |
| > I -   |                        | > possible, use\                  |
| >       |                        | > the time and temperature        |
| GENERAL |                        | > conditions of use listed in     |
| >       |                        | > Table 2 of 21\                  |
|  INFORM |                        | > CFR 176.170(c) to describe the  |
| ATION** |                        | > time and temperature conditions |
| >       |                        | > of\                             |
| > A     |                        | > use for the food contact        |
| > notif |                        | > substance formulation that is   |
| ication |                        | > the subject of\                 |
| > may   |                        | > this notification.              |
| > not   |                        | >                                 |
| > be    |                        | > **Part Vl - LIST OF             |
| > su    |                        | > ATTACHMENTS**                   |
| bmitted |                        | >                                 |
| > for a |                        | > Attach additional sheets if     |
| > form  |                        | > there is not enough space to    |
| ulation |                        | > answer a\                       |
| >       |                        | > question fully. Label each      |
|  unless |                        | > continuation sheet with the     |
| > all   |                        | > corresponding\                  |
| > of\   |                        | > section heading. List these     |
| > the   |                        | > attachments, any test data or   |
| > com   |                        | > other data\                     |
| ponents |                        | > and any optional information    |
| > of    |                        | > included in the notification.   |
| > the   |                        |                                   |
| > form  |                        | #### OPTIONAL INFORMATION         |
| ulation |                        |                                   |
| > may   |                        | > You may include any information |
| > be    |                        | > that you want FDA to consider   |
| >       |                        | > in\                             |
| legally |                        | > evaluating this notification.   |
| > m     |                        | >                                 |
| arketed |                        | > **CONFIDENTIALITY OF            |
| > for   |                        | > INFORMATION**                   |
| >       |                        | >                                 |
|  their\ |                        | > If you are claiming any         |
| > i     |                        | > information in this             |
| ntended |                        | > notification confidential\      |
| > use   |                        | > you should submit a redacted    |
| > in    |                        | > copy of the notification. FDA   |
| >       |                        | > may\                            |
| contact |                        | > disagree regarding the          |
| > with  |                        | > disclosability of information   |
| > food. |                        | > claimed\                        |
| > A     |                        | > confidential.                   |
| > notif |                        | >                                 |
| ication |                        | > **SAMPLES**                     |
| > for a |                        | >                                 |
| > food  |                        | > Provide a sample of the food    |
| > c     |                        | > contact substance formulation   |
| ontact\ |                        | > as\                             |
| > su    |                        | > intended for market.            |
| bstance |                        |                                   |
| > form  |                        |                                   |
| ulation |                        |                                   |
| >       |                        |                                   |
|  should |                        |                                   |
| >       |                        |                                   |
| include |                        |                                   |
| > all   |                        |                                   |
| > info  |                        |                                   |
| rmation |                        |                                   |
| > ne    |                        |                                   |
| cessary |                        |                                   |
| > to\   |                        |                                   |
| > es    |                        |                                   |
| tablish |                        |                                   |
| > that  |                        |                                   |
| > each  |                        |                                   |
| > c     |                        |                                   |
| ompound |                        |                                   |
| > in    |                        |                                   |
| > the   |                        |                                   |
| > form  |                        |                                   |
| ulation |                        |                                   |
| > may   |                        |                                   |
| > be    |                        |                                   |
| > l     |                        |                                   |
| egally\ |                        |                                   |
| > ma    |                        |                                   |
| rketed. |                        |                                   |
| > For   |                        |                                   |
| > e     |                        |                                   |
| xample, |                        |                                   |
| > add   |                        |                                   |
| itional |                        |                                   |
| > info  |                        |                                   |
| rmation |                        |                                   |
| > ne    |                        |                                   |
| cessary |                        |                                   |
| > to    |                        |                                   |
| > est   |                        |                                   |
| ablish\ |                        |                                   |
| > that  |                        |                                   |
| > each  |                        |                                   |
| > co    |                        |                                   |
| mponent |                        |                                   |
| > of    |                        |                                   |
| > the   |                        |                                   |
| > form  |                        |                                   |
| ulation |                        |                                   |
| > may   |                        |                                   |
| > be    |                        |                                   |
| >       |                        |                                   |
| legally |                        |                                   |
| > m     |                        |                                   |
| arketed |                        |                                   |
| > for\  |                        |                                   |
| > the   |                        |                                   |
| > i     |                        |                                   |
| ntended |                        |                                   |
| > use   |                        |                                   |
| > in    |                        |                                   |
| >       |                        |                                   |
| contact |                        |                                   |
| > with  |                        |                                   |
| > food  |                        |                                   |
| >       |                        |                                   |
|  should |                        |                                   |
| > be    |                        |                                   |
| > at    |                        |                                   |
| tached. |                        |                                   |
| > Any\  |                        |                                   |
| > info  |                        |                                   |
| rmation |                        |                                   |
| > ref   |                        |                                   |
| erenced |                        |                                   |
| > in a  |                        |                                   |
| > notif |                        |                                   |
| ication |                        |                                   |
| > must  |                        |                                   |
| > be    |                        |                                   |
| > su    |                        |                                   |
| bmitted |                        |                                   |
| > to    |                        |                                   |
| > FDA\  |                        |                                   |
| > prior |                        |                                   |
| > to    |                        |                                   |
| > your  |                        |                                   |
| >       |                        |                                   |
|  notifi |                        |                                   |
| cation. |                        |                                   |
| > If    |                        |                                   |
| > you   |                        |                                   |
| > re    |                        |                                   |
| ference |                        |                                   |
| > info  |                        |                                   |
| rmation |                        |                                   |
| > from  |                        |                                   |
| > a     |                        |                                   |
| >       |                        |                                   |
|  third\ |                        |                                   |
| > party |                        |                                   |
| > that  |                        |                                   |
| > is    |                        |                                   |
| >       |                        |                                   |
| located |                        |                                   |
| > in    |                        |                                   |
| > other |                        |                                   |
| > FDA   |                        |                                   |
| >       |                        |                                   |
|  files, |                        |                                   |
| >       |                        |                                   |
| provide |                        |                                   |
| > a     |                        |                                   |
| >       |                        |                                   |
|  letter |                        |                                   |
| > of\   |                        |                                   |
| >       |                        |                                   |
|  author |                        |                                   |
| ization |                        |                                   |
| > for   |                        |                                   |
| > such  |                        |                                   |
| > use,  |                        |                                   |
| > if    |                        |                                   |
| > nec   |                        |                                   |
| essary. |                        |                                   |
| > For   |                        |                                   |
| > e     |                        |                                   |
| xample, |                        |                                   |
| >       |                        |                                   |
|  author |                        |                                   |
| ization |                        |                                   |
| > is\   |                        |                                   |
| > not   |                        |                                   |
| > ne    |                        |                                   |
| cessary |                        |                                   |
| > to    |                        |                                   |
| > re    |                        |                                   |
| ference |                        |                                   |
| > p     |                        |                                   |
| ublicly |                        |                                   |
| > av    |                        |                                   |
| ailable |                        |                                   |
| > info  |                        |                                   |
| rmation |                        |                                   |
| > in    |                        |                                   |
| >       |                        |                                   |
|  FDA's\ |                        |                                   |
| >       |                        |                                   |
|  files. |                        |                                   |
| > If    |                        |                                   |
| > third |                        |                                   |
| > party |                        |                                   |
| >       |                        |                                   |
|  author |                        |                                   |
| ization |                        |                                   |
| > is    |                        |                                   |
| > re    |                        |                                   |
| quired, |                        |                                   |
| >       |                        |                                   |
| provide |                        |                                   |
| > the   |                        |                                   |
| > name  |                        |                                   |
| > of    |                        |                                   |
| > the\  |                        |                                   |
| > auth  |                        |                                   |
| orizing |                        |                                   |
| > o     |                        |                                   |
| fficial |                        |                                   |
| > for   |                        |                                   |
| > the   |                        |                                   |
| > third |                        |                                   |
| > party |                        |                                   |
| > and a |                        |                                   |
| >       |                        |                                   |
| mailing |                        |                                   |
| > a     |                        |                                   |
| ddress. |                        |                                   |
| >       |                        |                                   |
| > Two   |                        |                                   |
| >       |                        |                                   |
|  copies |                        |                                   |
| > of    |                        |                                   |
| > your  |                        |                                   |
| > c     |                        |                                   |
| omplete |                        |                                   |
| > notif |                        |                                   |
| ication |                        |                                   |
| > must  |                        |                                   |
| > be    |                        |                                   |
| > sub   |                        |                                   |
| mitted, |                        |                                   |
| > each\ |                        |                                   |
| > with  |                        |                                   |
| > a     |                        |                                   |
| > co    |                        |                                   |
| mpleted |                        |                                   |
| > and   |                        |                                   |
| >       |                        |                                   |
|  signed |                        |                                   |
| > o     |                        |                                   |
| riginal |                        |                                   |
| > copy. |                        |                                   |
| >       |                        |                                   |
| >       |                        |                                   |
|  **Part |                        |                                   |
| > II -  |                        |                                   |
| > IDE   |                        |                                   |
| NTITY** |                        |                                   |
| >       |                        |                                   |
| >       |                        |                                   |
| Provide |                        |                                   |
| > c     |                        |                                   |
| omplete |                        |                                   |
| > i     |                        |                                   |
| dentity |                        |                                   |
| > info  |                        |                                   |
| rmation |                        |                                   |
| > for   |                        |                                   |
| > all   |                        |                                   |
| > com   |                        |                                   |
| ponents |                        |                                   |
| > used  |                        |                                   |
| > to\   |                        |                                   |
| >       |                        |                                   |
| produce |                        |                                   |
| > the   |                        |                                   |
| > food  |                        |                                   |
| >       |                        |                                   |
| contact |                        |                                   |
| > su    |                        |                                   |
| bstance |                        |                                   |
| > formu |                        |                                   |
| lation. |                        |                                   |
| > If a  |                        |                                   |
| > co    |                        |                                   |
| mponent |                        |                                   |
| >       |                        |                                   |
|  (e.g.\ |                        |                                   |
| > a     |                        |                                   |
| >       |                        |                                   |
| reagent |                        |                                   |
| > or    |                        |                                   |
| > s     |                        |                                   |
| olvent) |                        |                                   |
| > is    |                        |                                   |
| > com   |                        |                                   |
| pletely |                        |                                   |
| >       |                        |                                   |
| removed |                        |                                   |
| > from  |                        |                                   |
| > the   |                        |                                   |
| > form  |                        |                                   |
| ulation |                        |                                   |
| > as\   |                        |                                   |
| > ma    |                        |                                   |
| rketed, |                        |                                   |
| > i     |                        |                                   |
| ndicate |                        |                                   |
| > so.   |                        |                                   |
| >       |                        |                                   |
| Provide |                        |                                   |
| > any   |                        |                                   |
| > r     |                        |                                   |
| elevant |                        |                                   |
| >       |                        |                                   |
| specifi |                        |                                   |
| cations |                        |                                   |
| > in    |                        |                                   |
| > order |                        |                                   |
| > to\   |                        |                                   |
| > es    |                        |                                   |
| tablish |                        |                                   |
| > that  |                        |                                   |
| > all   |                        |                                   |
| > com   |                        |                                   |
| ponents |                        |                                   |
| > of    |                        |                                   |
| > the   |                        |                                   |
| > form  |                        |                                   |
| ulation |                        |                                   |
| > may   |                        |                                   |
| > be    |                        |                                   |
| > la    |                        |                                   |
| wfully\ |                        |                                   |
| > ma    |                        |                                   |
| rketed. |                        |                                   |
|         |                        |                                   |
| #### Pa |                        |                                   |
| rt III  |                        |                                   |
| - INTEN |                        |                                   |
| DED USE |                        |                                   |
|         |                        |                                   |
| > If    |                        |                                   |
| > po    |                        |                                   |
| ssible, |                        |                                   |
| > use   |                        |                                   |
| > the   |                        |                                   |
| > food  |                        |                                   |
| > types |                        |                                   |
| >       |                        |                                   |
|  listed |                        |                                   |
| > in    |                        |                                   |
| > Table |                        |                                   |
| > 1 of  |                        |                                   |
| > 21    |                        |                                   |
| > CFR   |                        |                                   |
| > 176.  |                        |                                   |
| 170(c)\ |                        |                                   |
| > to    |                        |                                   |
| > d     |                        |                                   |
| escribe |                        |                                   |
| > the   |                        |                                   |
| > types |                        |                                   |
| > of    |                        |                                   |
| > food  |                        |                                   |
| > the   |                        |                                   |
| > food  |                        |                                   |
| >       |                        |                                   |
| contact |                        |                                   |
+---------+------------------------+-----------------------------------+
| ##      |                        |                                   |
| #### 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. |                        |                                   |
+---------+------------------------+-----------------------------------+

+----------+------------------+--------+---+--------+---+---------------+
| **PART   |                  |        |   |        |   |               |
| I -      |                  |        |   |        |   |               |
| GENERAL  |                  |        |   |        |   |               |
| INFOR    |                  |        |   |        |   |               |
| MATION** |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
| > **1a.  | NAME OF          |        |   | PO     |   |               |
| >        | AUTHORIZED       |        |   | SITION |   |               |
|  PERSON\ | OFFICIAL         |        |   |        |   |               |
| > SUB    |                  |        |   |        |   |               |
| MITTING\ |                  |        |   |        |   |               |
| >        |                  |        |   |        |   |               |
| NOTICE** |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
|          | COMPANY          |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
|          | MAILING ADDRESS  |        |   |        |   |               |
|          | *(number and     |        |   |        |   |               |
|          | street)*         |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
|          | CITY             | STATE  | Z |        |   | COUNTRY       |
|          |                  |        | I |        |   |               |
|          |                  |        | P |        |   |               |
|          |                  |        | C |        |   |               |
|          |                  |        | O |        |   |               |
|          |                  |        | D |        |   |               |
|          |                  |        | E |        |   |               |
|          |                  |        | / |        |   |               |
|          |                  |        | P |        |   |               |
|          |                  |        | O |        |   |               |
|          |                  |        | S |        |   |               |
|          |                  |        | T |        |   |               |
|          |                  |        | A |        |   |               |
|          |                  |        | L |        |   |               |
|          |                  |        | C |        |   |               |
|          |                  |        | O |        |   |               |
|          |                  |        | D |        |   |               |
|          |                  |        | E |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
|          | TELEPHONE NUMBER | FAX    |   |        | E |               |
|          |                  | NUMBER |   |        | - |               |
|          |                  |        |   |        | M |               |
|          |                  |        |   |        | A |               |
|          |                  |        |   |        | I |               |
|          |                  |        |   |        | L |               |
|          |                  |        |   |        | A |               |
|          |                  |        |   |        | D |               |
|          |                  |        |   |        | D |               |
|          |                  |        |   |        | R |               |
|          |                  |        |   |        | E |               |
|          |                  |        |   |        | S |               |
|          |                  |        |   |        | S |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
| > Please |                  |        |   |        |   |               |
| > check  |                  |        |   |        |   |               |
| > here   |                  |        |   |        |   |               |
| > if     |                  |        |   |        |   |               |
| > E-Mail |                  |        |   |        |   |               |
| > is     |                  |        |   |        |   |               |
| > your   |                  |        |   |        |   |               |
| > p      |                  |        |   |        |   |               |
| referred |                  |        |   |        |   |               |
| > method |                  |        |   |        |   |               |
| > of     |                  |        |   |        |   |               |
| > commun |                  |        |   |        |   |               |
| ication. |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
| > **1b.  | NAME OF          |        |   | PO     |   |               |
| > AGENT\ | AUTHORIZED       |        |   | SITION |   |               |
| > ***(If | OFFICIAL         |        |   |        |   |               |
| > appl   |                  |        |   |        |   |               |
| icable)* |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
|          | COMPANY          |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
|          | MAILING ADDRESS  |        |   |        |   |               |
|          | *(number and     |        |   |        |   |               |
|          | street)*         |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
|          | CITY             | STATE  | Z |        |   | COUNTRY       |
|          |                  |        | I |        |   |               |
|          |                  |        | P |        |   |               |
|          |                  |        | C |        |   |               |
|          |                  |        | O |        |   |               |
|          |                  |        | D |        |   |               |
|          |                  |        | E |        |   |               |
|          |                  |        | / |        |   |               |
|          |                  |        | P |        |   |               |
|          |                  |        | O |        |   |               |
|          |                  |        | S |        |   |               |
|          |                  |        | T |        |   |               |
|          |                  |        | A |        |   |               |
|          |                  |        | L |        |   |               |
|          |                  |        | C |        |   |               |
|          |                  |        | O |        |   |               |
|          |                  |        | D |        |   |               |
|          |                  |        | E |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
|          | TELEPHONE NUMBER | FAX    |   |        | E |               |
|          |                  | NUMBER |   |        | - |               |
|          |                  |        |   |        | M |               |
|          |                  |        |   |        | A |               |
|          |                  |        |   |        | I |               |
|          |                  |        |   |        | L |               |
|          |                  |        |   |        | A |               |
|          |                  |        |   |        | D |               |
|          |                  |        |   |        | D |               |
|          |                  |        |   |        | R |               |
|          |                  |        |   |        | E |               |
|          |                  |        |   |        | S |               |
|          |                  |        |   |        | S |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
|          |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+
| > Please |                  |        |   |        |   |               |
| > check  |                  |        |   |        |   |               |
| > here   |                  |        |   |        |   |               |
| > if     |                  |        |   |        |   |               |
| > E-Mail |                  |        |   |        |   |               |
| > is     |                  |        |   |        |   |               |
| > your   |                  |        |   |        |   |               |
| > p      |                  |        |   |        |   |               |
| referred |                  |        |   |        |   |               |
| > method |                  |        |   |        |   |               |
| > of     |                  |        |   |        |   |               |
| > commun |                  |        |   |        |   |               |
| ication. |                  |        |   |        |   |               |
+----------+------------------+--------+---+--------+---+---------------+

+-----------+-----------+-------+------+-------+-------+-------------+
| **PART    |           |       |      |       |       |             |
| II -      |           |       |      |       |       |             |
| I         |           |       |      |       |       |             |
| DENTITY** |           |       |      |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
| ###### SE |           |       |      |       |       |             |
| CTION A - |           |       |      |       |       |             |
|  IDENTIFI |           |       |      |       |       |             |
| CATION OF |           |       |      |       |       |             |
|  THE FOOD |           |       |      |       |       |             |
|  CONTACT  |           |       |      |       |       |             |
| SUBSTANCE |           |       |      |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
| 1\.       |           |       |      |       |       |             |
| CHEMICAL  |           |       |      |       |       |             |
| IDENTITY  |           |       |      |       |       |             |
|           |           |       |      |       |       |             |
| >         |           |       |      |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
| > TRADE   |           |       |      |       |       |             |
| > OR      |           |       |      |       |       |             |
| > COMMON  |           |       |      |       |       |             |
| > NAMES   |           |       |      |       |       |             |
| >         |           |       |      |       |       |             |
| >         |           |       |      |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
| 2\.       |           |       |      |       |       |             |
| FO        |           |       |      |       |       |             |
| RMULATION |           |       |      |       |       |             |
| CO        |           |       |      |       |       |             |
| MPOSITION |           |       |      |       |       |             |
|           |           |       |      |       |       |             |
| >         |           |       |      |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
| *         |           | *     | **M  | **    | **    | **TECHNICAL |
| *CHEMICAL |           | *TYPI | AXIM | CAS** | BASIS | EFFECT**    |
| NAME AND  |           | CAL** | UM** |       | FOR** |             |
| MANUF     |           |       |      | *     |       | **(7)**     |
| ACTURER** |           | **COM | **RE | *REG. | **CO  |             |
|           |           | POSIT | SIDU | NO.** | MPLIA |             |
|           |           | ION** | AL** |       | NCE** |             |
|           |           |       |      | **    |       |             |
|           |           | **    | **(  | (5)** | **    |             |
|           |           | (3)** | 4)** |       | (6)** |             |
+-----------+-----------+-------+------+-------+-------+-------------+
| *         | **MAN     |       |      |       |       |             |
| *CHEMICAL | UFACTURER |       |      |       |       |             |
| NAME      | (2)**     |       |      |       |       |             |
| (1)**     |           |       |      |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+
|           |           |       |      |       |       |             |
|           |           | %     |      |       |       |             |
|           |           |       | %    |       |       |             |
+-----------+-----------+-------+------+-------+-------+-------------+

+-----------------------------------+-----------------------------------+
| **PART II - INFORMATION ON        |                                   |
| IDENTITY, USE AND EXPOSURE**      |                                   |
| *(continued)*                     |                                   |
+-----------------------------------+-----------------------------------+
| **SECTION A - IDENTIFICATION**    |                                   |
| *(continued)*                     |                                   |
+-----------------------------------+-----------------------------------+
| b\. CHARACTERIZATION              |                                   |
|                                   |                                   |
| List those characteristics of the |                                   |
| formulation necessary to verify   |                                   |
| that the formulation may be       |                                   |
| lawfully marketed.                |                                   |
+-----------------------------------+-----------------------------------+
| ###### POLYMER PROPERTIES         | ###### VALUES                     |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
|                                   |                                   |
+-----------------------------------+-----------------------------------+
| c\. Describe the manufacturing    |                                   |
| process, including times and      |                                   |
| temperatures, and include         |                                   |
| chemical equations 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 IV of this form.          |                                   |
+-----------------------------------+-----------------------------------+

+-----------------------------------------------------------------------+
| **PART III - INTENDED USE**                                           |
+-----------------------------------------------------------------------+
| 1\. Describe the intended use of the food contact substance           |
| formulation, including maximum use levels (or thickness) in food      |
| contact materials, and\                                               |
| types of food contact articles in which it is expected to be used     |
| (e.g., films, coatings, molded articles). State whether single or     |
| repeated use is\                                                      |
| intended. Provide maximum temperatures and times of food contact,     |
| refer to classifications in 21 CFR 176.170(c) Table 2 when possible.  |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section IV of this form.                |
+-----------------------------------------------------------------------+
| 2\. List types of food expected to contact the formulation, with      |
| examples if known. Refer to classifications in 21 CFR 176.170(c)      |
| Table 1 when\                                                         |
| possible.                                                             |
|                                                                       |
| >                                                                     |
+-----------------------------------------------------------------------+
| Mark (X) this box if you attach a continuation sheet. Enter the       |
| attachment name and number in Section IV of this form.                |
+-----------------------------------------------------------------------+

+--------------------------------+------+-------+---+----------+--------+
| **PHYSICAL AND CHEMICAL        |      |       |   |          |        |
| PROPERTIES WORKSHEET**         |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| To assist FDA's review of      |      |       |   |          |        |
| physical and chemical          |      |       |   |          |        |
| properties data, please        |      |       |   |          |        |
| complete the following         |      |       |   |          |        |
| worksheet for data you provide |      |       |   |          |        |
| and\                           |      |       |   |          |        |
| include it in the              |      |       |   |          |        |
| notification. Identify the     |      |       |   |          |        |
| property measured, the page of |      |       |   |          |        |
| the notification on which the  |      |       |   |          |        |
| property appears, the value    |      |       |   |          |        |
| of\                            |      |       |   |          |        |
| the property, and the units in |      |       |   |          |        |
| which the property is measured |      |       |   |          |        |
| (as necessary). The measured   |      |       |   |          |        |
| properties should be for the   |      |       |   |          |        |
| food\                          |      |       |   |          |        |
| contact substance formulation. |      |       |   |          |        |
| You are not required to submit |      |       |   |          |        |
| this worksheet.                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| **PROPERTY**                   | **   | **P   | * |          | **ME   |
|                                | MARK | AGE** | * |          | ASURED |
| **(a)**                        | (    |       | V |          | OR**   |
|                                | X)** | **NUM | A |          |        |
|                                |      | BER** | L |          | **ESTI |
|                                | **   |       | U |          | MATE** |
|                                | IF** | **    | E |          |        |
|                                |      | (b)** | * |          | **(M   |
|                                | **PR |       | * |          | or     |
|                                | OVID |       |   |          | E)**   |
|                                | ED** |       | * |          |        |
|                                |      |       | * |          |        |
|                                |      |       | ( |          |        |
|                                |      |       | c |          |        |
|                                |      |       | ) |          |        |
|                                |      |       | * |          |        |
|                                |      |       | * |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Physical state of the          |      |       |   |          | M E    |
| substance                      |      |       | ( |          |        |
|                                |      |       | s |          |        |
|                                |      |       | ) |          |        |
|                                |      |       | ( |          |        |
|                                |      |       | l |          |        |
|                                |      |       | ) |          |        |
|                                |      |       | ( |          |        |
|                                |      |       | g |          |        |
|                                |      |       | ) |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Vapor pressure                 |      |       |   |          | M E    |
|                                |      |       |   |          |        |
| \@Temperature                  |      |       |   |          |        |
| [     ]{.underline} °C         |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       | T |          |        |
|                                |      |       | o |          |        |
|                                |      |       | r |          |        |
|                                |      |       | r |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Density/relative density       |      |       |   |          | M E    |
| *(specify temperature)*        |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       | g |          |        |
|                                |      |       | / |          |        |
|                                |      |       | c |          |        |
|                                |      |       | m |          |        |
|                                |      |       | ^ |          |        |
|                                |      |       | 3 |          |        |
|                                |      |       | ^ |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Solubility                     |      |       |   |          | M E    |
|                                |      |       |   |          |        |
| \@Temperature                  |      |       |   |          |        |
| [     ]{.underline} °C         |      |       |   |          |        |
| [     ]{.underline} Solvent    |      |       |   |          |        |
|                                |      |       | g |          |        |
|                                |      |       | / |          |        |
|                                |      |       | L |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Solubility in water            |      |       |   |          | M E    |
| \@Temperature                  |      |       |   |          |        |
| [     ]{.underline} °C         |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       | g |          |        |
|                                |      |       | / |          |        |
|                                |      |       | L |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Melting Temperature            |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       | ° |          |        |
|                                |      |       | C |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Boiling/sublimation            |      |       |   |          | M E    |
| temperature @                  |      |       |   |          |        |
| [     ]{.underline} torr       |      |       |   |          |        |
| pressure                       |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       | ° |          |        |
|                                |      |       | C |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Spectra                        |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Dissociation constant          |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Particle size distribution     |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Octanol/water partition        |      |       |   |          | M E    |
| coefficient                    |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Henry's Law constant           |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| pH [     ]{.underline} @       |      |       |   |          | M E    |
| concentration                  |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Adsorption/coefficient         |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Other -- Specify               |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Polymer specific               |      |       |   |          | M E    |
|                                |      |       |   |          |        |
| *(If a range is applicable,    |      |       |   |          |        |
| indicate so)*                  |      |       |   |          |        |
|                                |      |       |   |          |        |
| \% crystallinity of polymer    |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Degree of orientation          |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Thermal transitions of polymer |      |       |   |          | M E    |
| *(i.e., Tg, Tm)*               |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| Density of polymer *(specify   |      |       |   |          | M E    |
| temperature)*                  |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          | M E    |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| **PART IV - LIST OF            |      |       |   |          |        |
| ATTACHMENTS**                  |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| 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, if           |      |       |   |          |        |
| appropriate. Number            |      |       |   |          |        |
| consecutively the pages of the |      |       |   |          |        |
| attachments. In the column     |      |       |   |          |        |
| below, enter the inclusive     |      |       |   |          |        |
| page\                          |      |       |   |          |        |
| numbers of each attachment.    |      |       |   |          |        |
| Notifiers need not list other  |      |       |   |          |        |
| components of their            |      |       |   |          |        |
| notification not specifically  |      |       |   |          |        |
| referenced to this form.       |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
| **ATTACHMENT NAME**            |      |       |   | **ATTA   |        |
|                                |      |       |   | CHMENT** |        |
|                                |      |       |   |          |        |
|                                |      |       |   | **PAGE   |        |
|                                |      |       |   | NUM      |        |
|                                |      |       |   | BER(S)** |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+
|                                |      |       |   |          |        |
+--------------------------------+------+-------+---+----------+--------+