+--------------------------------------------------+-------------------+
| **[World Trade]{.smallcaps}**                    |                   |
|                                                  |                   |
| **[Organization]{.smallcaps}**                   |                   |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
|                                                  | **                |
|                                                  | G/TBT/N/USA/113** |
|                                                  |                   |
|                                                  | 18 May 2005       |
+--------------------------------------------------+-------------------+
|                                                  | (05-2024)         |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
| **Committee on Technical Barriers to Trade**     | Original: English |
+--------------------------------------------------+-------------------+

NOTIFICATION

The following notification is being circulated in accordance with
Article 10.6.

+----+---------------------------+---+---------------------------------+
| ** | **Member to Agreement     |   |                                 |
| 1. | notifying:** [United      |   |                                 |
| ** | States]{.underline}       |   |                                 |
|    |                           |   |                                 |
|    | **If applicable, name of  |   |                                 |
|    | local government involved |   |                                 |
|    | (Articles 3.2 and 7.2):** |   |                                 |
|    |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Agency responsible:**   |   |                                 |
| 2. | Food and Drug             |   |                                 |
| ** | Administration (118)      |   |                                 |
|    |                           |   |                                 |
|    | **Name and address        |   |                                 |
|    | (including telephone and  |   |                                 |
|    | fax numbers, e-mail and   |   |                                 |
|    | web-site addresses, if    |   |                                 |
|    | available) of** **agency  |   |                                 |
|    | or authority designated   |   |                                 |
|    | to handle comments        |   |                                 |
|    | regarding the             |   |                                 |
|    | notification shall be     |   |                                 |
|    | indicated if different    |   |                                 |
|    | from above:**             |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Notified under Article  |   |                                 |
| 3. | 2.9.2 \[** X **\], 2.10.1 |   |                                 |
| ** | \[ **  **\], 5.6.2        |   |                                 |
|    | \[ **  **\], 5.7.1        |   |                                 |
|    | \[ **  **\], other:**     |   |                                 |
|    |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Products covered (HS or |   |                                 |
| 4. | CCCN where applicable,    |   |                                 |
| ** | otherwise national tariff |   |                                 |
|    | heading.\                 |   |                                 |
|    | ICS numbers may be        |   |                                 |
|    | provided in addition,     |   |                                 |
|    | where applicable):**      |   |                                 |
|    | Sucralose\                |   |                                 |
|    | (HS Chapter: 2106; ICS:   |   |                                 |
|    | 67)                       |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Title, number of pages  |   |                                 |
| 5. | and language(s) of the    |   |                                 |
| ** | notified document:** Food |   |                                 |
|    | Labeling; Health Claims;  |   |                                 |
|    | Dietary Noncariogenic     |   |                                 |
|    | Carbohydrate Sweeteners   |   |                                 |
|    | and Dental Caries         |   |                                 |
|    | (7 pages, in English)     |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Description of          |   |                                 |
| 6. | content:** The Food and   |   |                                 |
| ** | Drug Administration (FDA) |   |                                 |
|    | is proposing to amend the |   |                                 |
|    | regulation authorizing a  |   |                                 |
|    | health claim on           |   |                                 |
|    | noncariogenic             |   |                                 |
|    | carbohydrate sweeteners   |   |                                 |
|    | and dental caries, i.e.,  |   |                                 |
|    | tooth decay, to include   |   |                                 |
|    | sucralose, a nonnutritive |   |                                 |
|    | sweetener. Similar to the |   |                                 |
|    | sweeteners currently      |   |                                 |
|    | authorized to make a      |   |                                 |
|    | health claim, sucralose   |   |                                 |
|    | is used as a sugar        |   |                                 |
|    | substitute that is        |   |                                 |
|    | minimally fermented,      |   |                                 |
|    | relative to sugar, by     |   |                                 |
|    | oral microorganisms and   |   |                                 |
|    | thus does not contribute  |   |                                 |
|    | to production of organic  |   |                                 |
|    | acids by plaque bacteria  |   |                                 |
|    | as do the fermentable     |   |                                 |
|    | sugars for which it is a  |   |                                 |
|    | substitute. FDA is taking |   |                                 |
|    | this action in response   |   |                                 |
|    | to a health claim         |   |                                 |
|    | petition filed by McNeil  |   |                                 |
|    | Nutritionals. The agency  |   |                                 |
|    | previously concluded that |   |                                 |
|    | there was significant     |   |                                 |
|    | scientific agreement for  |   |                                 |
|    | the relationship between  |   |                                 |
|    | slowly fermented          |   |                                 |
|    | carbohydrate sugar        |   |                                 |
|    | substitutes, specifically |   |                                 |
|    | certain sugar alcohols,   |   |                                 |
|    | and the nonpromotion of   |   |                                 |
|    | dental caries. Based on   |   |                                 |
|    | the totality of publicly  |   |                                 |
|    | available scientific      |   |                                 |
|    | evidence, FDA now has     |   |                                 |
|    | determined that the       |   |                                 |
|    | nonnutritive sweetener    |   |                                 |
|    | sucralose, like the sugar |   |                                 |
|    | alcohols, is not          |   |                                 |
|    | fermented by oral         |   |                                 |
|    | bacteria to an extent     |   |                                 |
|    | sufficient to lower       |   |                                 |
|    | dental plaque pH to       |   |                                 |
|    | levels that would         |   |                                 |
|    | contribute to the erosion |   |                                 |
|    | of dental enamel.         |   |                                 |
|    | Therefore, FDA has        |   |                                 |
|    | concluded that sucralose  |   |                                 |
|    | does not promote dental   |   |                                 |
|    | caries, and it is         |   |                                 |
|    | proposing to amend the    |   |                                 |
|    | regulation authorizing a  |   |                                 |
|    | health claim relating     |   |                                 |
|    | certain noncariogenic     |   |                                 |
|    | sweeteners and            |   |                                 |
|    | nonpromotion of dental    |   |                                 |
|    | caries to include         |   |                                 |
|    | sucralose as a substance  |   |                                 |
|    | eligible for the claim.   |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Objective and           |   |                                 |
| 7. | rationale, including the  |   |                                 |
| ** | nature of urgent problems |   |                                 |
|    | where applicable:**       |   |                                 |
|    | Protection of human       |   |                                 |
|    | health                    |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Relevant documents:**   |   |                                 |
| 8. | 70 Federal Register (FR)  |   |                                 |
| ** | 25496 13 May 2005; Title  |   |                                 |
|    | 21 Code of Federal        |   |                                 |
|    | Regulations (CFR) Part    |   |                                 |
|    | 101. Will appear in the   |   |                                 |
|    | Federal Register when     |   |                                 |
|    | adopted.                  |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Proposed date of        | } | To be determined                |
| 9. | adoption:**               |   |                                 |
| ** |                           |   |                                 |
|    | **Proposed date of entry  |   |                                 |
|    | into force:**             |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **Final date for          |   |                                 |
| *1 | comments:** 27 July 2005  |   |                                 |
| 0. |                           |   |                                 |
| ** |                           |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **Texts available from:   |   |                                 |
| *1 | National enquiry point    |   |                                 |
| 1. | \[** X **\] or address,   |   |                                 |
| ** | telephone and fax         |   |                                 |
|    | numbers, e-mail and       |   |                                 |
|    | web-site addresses, if    |   |                                 |
|    | available of the other    |   |                                 |
|    | body:**                   |   |                                 |
|    |                           |   |                                 |
|    | Full Text of this         |   |                                 |
|    | Notification is Now       |   |                                 |
|    | Available on the Internet |   |                                 |
|    | at URLs:                  |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akama      |   |                                 |
|    | itech.net/7/257/2422/01ja |   |                                 |
|    | n20051800/edocket.access. |   |                                 |
|    | gpo.gov/2005/05-9608.htm> |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akamaitec  |   |                                 |
|    | h.net/7/257/2422/01jan200 |   |                                 |
|    | 51800/edocket.access.gpo. |   |                                 |
|    | gov/2005/pdf/05-9608.pdf> |   |                                 |
+----+---------------------------+---+---------------------------------+