Regulatory Updates
<p>TITLE: Trichloroethylene (TCE); Regulation of Certain Uses Under Toxic Substances Control Act; Extension of Comment Periods</p><p>AGENCY: Environmental Protection Agency (EPA)</p><p>ACTION: Proposed rule; extension of comment periods</p><p>SUMMARY: EPA issued two proposed rules under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the manufacture (including importers), processing, and distribution in commerce of trichloroethylene (TCE) for use in aerosol degreasing, for use in spot cleaning in dry cleaning facilities, and for use in vapor degreasing; to prohibit commercial use of TCE for aerosol degreasing, for spot cleaning in dry cleaning facilities, and for use in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping. This document extends the comment periods for both proposed rules by an additional 30 calendar days each. A commenter requested additional time to submit written comments for the proposed rules. EPA is therefore extending the comment period in order to give all interested persons the opportunity to comment fully.</p><p>DATES: The comment period of the proposed rule published in the Federal Register of 16 December 2016 (81 FR 91592) is extended to 16 March 2017, and the comment date of the proposed rule published in the Federal Register of 19 January 2017 (82 FR 7432) is delayed to 19 April 2017. </p><p></p>
Distribution date: 20 February 2017
Products Covered: Trichloroethylene (TCE)
Regulation Type: Addendum to Regular Notification
The Republic of Peru hereby advises that the Regulation on the presentation and content of the documents required for the registration and re-registration of similar biological products, the draft version of which was notified on 15 April 2015 in document G/TBT/N/PER/70, was issued pursuant to Supreme Decree No. 013 2016 SA, published in the Official Journal El Peruano on 1 March 2016, and entered into force 180 days after publication. Text available at: http://www.digemid.minsa.gob.pe/Main.asp?Seccion=475
Distribution date: 17 February 2017
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Addendum to Regular Notification
The Republic of Peru hereby advises that the "Supreme Decree amending Article 103 of the Regulations on the registration, control and sanitary surveillance of pharmaceutical products, medical devices and sanitary products" and the "Regulations on the presentation and content of the documents required for the registration and re-registration of biological products: biotech products", the draft versions of which were notified on 15 April 2015 in document G/TBT/N/PER/69, were issued pursuant to Supreme Decree No. 011-2016-SA, published in the Official Journal El Peruano on 20 February 2016, and entered into force 180 days after publication. Text available at: http://www.digemid.minsa.gob.pe/Main.asp?Seccion=475
Distribution date: 17 February 2017
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Addendum to Regular Notification
Ban on the testing of cosmetics on animals in Australia - Background Paper (8 pages, in English).
Distribution date: 16 February 2017 | Final date for Comment: 17 April 2017
<div><table align="center" cellpadding="0" cellspacing="0" hspace="0" vspace="0"><tbody><tr><td align="left" style="padding:0cm 9pt;" valign="top"><p><span style="line-height:1.5;letter-spacing:-0.1pt;font-size:12pt;">The Australian Government has committed to a ban on testing cosmetics on animals, and is investigating changes to existing requirements as part of developing options for implementation. This involves a process of broad consultation and policy design.</span></p><p><span style="letter-spacing:-0.1pt;font-size:12pt;">Information about the consultation process can be found on the Department of Health website: </span><span style="font-size:12pt;"><a href="http://www.health.gov.au/internet/main/publishing.nsf/Content/ban-cosmetic-testing-animals">http://www.health.gov.au/internet/main/publishing.nsf/Content/ban-cosmetic-testing-animals</a></span></p><p><span style="letter-spacing:-0.1pt;font-size:12pt;">The package contains a paper which sets out background and contextual information and provides an overview of the regulation of cosmetics in Australia. The background paper does not provide a comprehensive analysis of the issue or put forward policy options.</span></p><p><span style="letter-spacing:-0.1pt;font-size:12pt;">Australia welcomes views and contributions from trading partners in the consultation process. </span></p></td></tr></tbody></table></div>
Products Covered: Cosmetics and cosmetic ingredients, including (but not limited to) those contained in HS Chapters 28, 29 and 33.
Regulation Type: Regular notification
<p>The Separate Customs Territory of Taiwan, Penghu, Kinmen and Matsu would like to notified that the "Amendment to Legal Inspection Requirements of Gas Cylinders and the Fuel thereof for Portable Gas Stoves, Blowtorches and Refillable Lighters", as per G/TBT/N/TPKM/254 on 4 November 2016, was promulgated on 23 January 2017 and will come into effect on 1 July 2017.</p><p>For further information, please contact:</p><p>TPKM-WTO/TBT Enquiry Point<br />Bureau of Standards, Metrology and Inspection<br />Ministry of Economic Affairs<br />No. 4, Sec. 1, Jinan Rd. <br />Zhongzheng Dist., Taipei City 100, Taiwan <br />Tel: +(886 2) 2343-1813<br />Fax: +(886 2) 2343-1804 <br />E-mail: <a href="mailto:tbtenq@bsmi.gov.tw">tbtenq@bsmi.gov.tw</a></p>
Distribution date: 13 February 2017
Products Covered: Gas cylinders and the fuel thereof for portable gas stoves, blowtorches and refillable lighters (refer to attachment)
Regulation Type: Addendum to Regular Notification
Partial amendment to the Minimum Requirements for Biological Products (1 page, in English)
Distribution date: 13 February 2017 | Final date for Comment: 11 March 2017
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';mso-bidi-language:AR-SA;mso-fareast-theme-font:minor-fareast;"></span></span>The Minimum Requirements for Biological Products shall be partially amended to add the standard and the reagents for the blood product to be newly approved.
Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)
Regulation Type: Regular notification
By means of this Addendum No. 5, the Republic of Ecuador advises that Amendment No. 4 to Ecuadorian Standardization Institute Technical Regulation (RTE INEN) No. 088 "Surface tension agents", notified on 24 October 2014 in document G/TBT/N/ECU/106/Add.1, was issued pursuant to Resolution No. 16 518 of 20 December 2016 of the Under-Secretariat for the Quality System of the Ministry of Industry and Productivity, published in Official Journal No. 940 of 8 February 2017. Text available from: Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) Subsecretaría de la Calidad (Under-Secretariat for Quality) Organismo Nacional encargado de la Notificación (National Notification Authority) Contact person: Marlon Martínez B. Yánez Pinzón N26-12, entre Av. Colón y La Niña Quito, Ecuador Tel.: (+593-2) 394-8760, Ext. 2358 / 2255 Email: PuntocontactoOTCECU@mipro.gob.ec / mmartinez@mipro.gob.ec
Distribution date: 10 February 2017
Products Covered: 34.01.11.00, 34.01.19.00, 34.01.19.10, 34.01.19.90, 34.01.20.00, 34.01.30.00, 34.02.11.10, 34.02.11.90, 34.02.12.10, 34.02.12.90 and 34.02.13.10. ;
Regulation Type: Addendum to Regular Notification
Notice of Consultation - Prescription Drug List (PDL): Hydroquinone (2 pages, in English and French)
Distribution date: 07 February 2017 | Final date for Comment: 08 April 2017
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:Verdana, sans-serif;font-size:9pt;">This Notice of Consultation provides an opportunity to comment on the proposal to add hydroquinone to the Prescription Drug List (PDL) when sold in a concentration greater than 2% in topical products.</span></span>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)
Regulation Type: Regular notification
Amendments to Fireworks Regulations (23 pages, in English).
Distribution date: 06 February 2017 | Final date for Comment: 07 April 2017
<pre>The Consumer Product Safety Commission (Commission or CPSC) proposes to amend its regulations regarding fireworks devices under the Federal Hazardous Substances Act. The proposed amendments are based on the Commission's review of its existing fireworks regulations, the current fireworks market, changes in technology, existing fireworks standards, and safety issues associated with fireworks devices. The proposed amendments would create new requirements and modify or clarify existing requirements. Some of the proposed revisions would align with existing fireworks standards or codify the Commission's existing testing practices. The Commission believes that the proposed requirements would improve consumer safety by codifying limits, test procedures, and requirements that would reduce the risk of injury to consumers and clarifying existing requirements to promote compliance. </pre>
Products Covered: Fireworks
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Law (Revision of agricultural chemical residue standards)
Distribution date: 02 February 2017
This notice is issued to correct the Description of Content in Item 6 of notification G/SPS/N/JPN/500, dated 27 January 2017, as follows: "Dazomet, Metam and Methyl isothiocyanate are used as pesticide respectively. Dazomet and Methyl isothiocyanate can be readily metabolized to Methyl isothiocyanate in plants. Therefore, Japan is considering the MRL as a group of these substances." should be replaced with "Dazomet, Metam and Methyl isothiocyanate are used as pesticide respectively. Dazomet and Metam can be readily metabolized to Methyl isothiocyanate in plants. Therefore, Japan is considering the MRL as a group of these substances."
Products Covered:
Regulation Type: Corrigendum to Regular Notification
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