+--------------------------------------------------+-------------------+
| **[World Trade]{.smallcaps}**                    |                   |
|                                                  |                   |
| **[Organization]{.smallcaps}**                   |                   |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
|                                                  | *                 |
|                                                  | *G/TBT/N/USA/84** |
|                                                  |                   |
|                                                  | 8 October 2004    |
+--------------------------------------------------+-------------------+
|                                                  | (04-4223)         |
+--------------------------------------------------+-------------------+
|                                                  |                   |
+--------------------------------------------------+-------------------+
| **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 (87)       |   |                                 |
|    |                           |   |                                 |
|    | **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):**      |   |                                 |
|    |                           |   |                                 |
|    | Cosmetics (HS Chapter     |   |                                 |
|    | 3304) (ICS 71.100)        |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Title, number of pages  |   |                                 |
| 5. | and language(s) of the    |   |                                 |
| ** | notified document:**      |   |                                 |
|    | Listing of Color          |   |                                 |
|    | Additives Subject to      |   |                                 |
|    | Certification; D&C Black  |   |                                 |
|    | No. 2; (4 pages, in       |   |                                 |
|    | English)                  |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Description of          |   |                                 |
| 6. | content:** FDA announces  |   |                                 |
| ** | a Final Rule adding       |   |                                 |
|    | Section 74.2052 to part   |   |                                 |
|    | 74 of Title 21 of the     |   |                                 |
|    | Code of Federal           |   |                                 |
|    | Regulations to provide    |   |                                 |
|    | for the safe use of D&C   |   |                                 |
|    | Black No. 2, a high       |   |                                 |
|    | purity furnace black,     |   |                                 |
|    | subject to FDA batch      |   |                                 |
|    | certification, as a color |   |                                 |
|    | additive in the following |   |                                 |
|    | cosmetics: Eyeliner,      |   |                                 |
|    | brush-on-brow, eye        |   |                                 |
|    | shadow, mascara,          |   |                                 |
|    | lipstick, blushers and    |   |                                 |
|    | rouge, makeup and         |   |                                 |
|    | foundation, and nail      |   |                                 |
|    | enamel. The regulation    |   |                                 |
|    | describes the identity,   |   |                                 |
|    | specifications, uses and  |   |                                 |
|    | restrictions, labelling,  |   |                                 |
|    | and certification         |   |                                 |
|    | requirements for the safe |   |                                 |
|    | use of the color additive |   |                                 |
|    | in cosmetics in the       |   |                                 |
|    | United States.            |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Objective and           |   |                                 |
| 7. | rationale, including the  |   |                                 |
| ** | nature of urgent problems |   |                                 |
|    | where applicable:** FDA   |   |                                 |
|    | concludes that there is a |   |                                 |
|    | reasonable certainty that |   |                                 |
|    | no harm will result from  |   |                                 |
|    | the petitioned use of D&C |   |                                 |
|    | Black No. 2 as a color    |   |                                 |
|    | additive in the following |   |                                 |
|    | cosmetics: Eyeliner,      |   |                                 |
|    | brush-on-brow, eye        |   |                                 |
|    | shadow, mascara,          |   |                                 |
|    | lipstick, blushers and    |   |                                 |
|    | rouge, makeup and         |   |                                 |
|    | foundation, and nail      |   |                                 |
|    | enamel. The agency also   |   |                                 |
|    | concludes that the color  |   |                                 |
|    | additive will achieve its |   |                                 |
|    | intended technical        |   |                                 |
|    | effect, and thus, is      |   |                                 |
|    | suitable for this use.    |   |                                 |
|    | Because the color         |   |                                 |
|    | additive may contain low  |   |                                 |
|    | levels of potentially     |   |                                 |
|    | carcinogenic polynuclear  |   |                                 |
|    | aromatic hydrocarbon      |   |                                 |
|    | (PAH) contaminants, the   |   |                                 |
|    | FDA set PAH               |   |                                 |
|    | specifications for D&C    |   |                                 |
|    | Black No. 2 and is        |   |                                 |
|    | requiring that the color  |   |                                 |
|    | additive be from a batch  |   |                                 |
|    | that has been certified   |   |                                 |
|    | by FDA. In addition, to   |   |                                 |
|    | limit the amounts of      |   |                                 |
|    | heavy metals present in   |   |                                 |
|    | the color additive,       |   |                                 |
|    | specifications have been  |   |                                 |
|    | set for arsenic, lead,    |   |                                 |
|    | and mercury.              |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Relevant documents:**   |   |                                 |
| 8. | 69 Federal Register (FR)  |   |                                 |
| ** | 44927 28 July 2004; Title |   |                                 |
|    | 21 Code of Federal        |   |                                 |
|    | Regulations (CFR) Part    |   |                                 |
|    | 74. Will appear in the    |   |                                 |
|    | Federal Register when     |   |                                 |
|    | adopted.                  |   |                                 |
+----+---------------------------+---+---------------------------------+
| ** | **Proposed date of        |   | 30 August 2004                  |
| 9. | adoption:**               |   |                                 |
| ** |                           |   |                                 |
|    | **Proposed date of entry  |   |                                 |
|    | into force:**             |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **Final date for          |   |                                 |
| *1 | comments:** Comments on   |   |                                 |
| 0. | the rule can be submitted |   |                                 |
| ** | anytime; however, the     |   |                                 |
|    | final date for filing     |   |                                 |
|    | objections to the rule    |   |                                 |
|    | was 27 August 2004. No    |   |                                 |
|    | objections were received. |   |                                 |
+----+---------------------------+---+---------------------------------+
| *  | **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:      **             |   |                                 |
|    |                           |   |                                 |
|    | **Available on the        |   |                                 |
|    | Internet at URLs:**       |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akamai     |   |                                 |
|    | tech.net/7/257/2422/06jun |   |                                 |
|    | 20041800/edocket.access.g |   |                                 |
|    | po.gov/2004/04-17153.htm> |   |                                 |
|    |                           |   |                                 |
|    | <http://a257.g.akamaitech |   |                                 |
|    | .net/7/257/2422/06jun2004 |   |                                 |
|    | 1800/edocket.access.gpo.g |   |                                 |
|    | ov/2004/pdf/04-17153.pdf> |   |                                 |
+----+---------------------------+---+---------------------------------+