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

Product Image

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).

Product Image

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.&nbsp; 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.&nbsp;</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

Animal welfare Animal health

<p>The Separate Customs Territory of Taiwan, Penghu,&nbsp; 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&nbsp; 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:[email protected]">[email protected]</a></p>

Product Image

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)

Product Image

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

Human health

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: [email protected] / [email protected]

Product Image

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)

Product Image

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

Human health

Amendments to Fireworks Regulations (23 pages, in English).

Product Image

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)

Product Image

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

Food safety Human health Pesticides Maximum residue limits (MRLs)

Trichloroethylene (TCE); Regulation of Use in Vapor Degreasing Under TSCA Section 6(a) (30 pages, in English).

Product Image

Distribution date: 01 February 2017 | Final date for Comment: 20 March 2017

<pre>Trichloroethylene (TCE) is a volatile organic compound widely used in industrial and commercial processes and has some limited uses in consumer and commercial products. EPA identified significant health risks associated with TCE use in vapour degreasing and EPA's proposed determination is that these risks are unreasonable risks. To address these unreasonable risks, EPA is proposing under section 6 of the Toxic Substances Control Act (TSCA) to prohibit the manufacture (including import), processing, and distribution in commerce of TCE for use in vapour degreasing; to prohibit commercial use of TCE in vapour degreasing; to require manufacturers, 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. </pre>

Products Covered: Trichloroethylene (TCE)

Regulation Type: Regular notification

Methylene Chloride and N-Methylpyrrolidone; Regulation of Certain Uses Under TSCA Section 6(a) (70 pages, in English).

Product Image

Distribution date: 01 February 2017 | Final date for Comment: 02 April 2017

<pre>Methylene chloride, also called dichloromethane, is a volatile chemical that has a variety of uses, including paint and coating removal. N-methylpyrrolidone (NMP) is a solvent used in a variety of applications, including paint and coating removal. For each of these chemicals, EPA has identified risks of concern associated with their use in paint and coating removal. EPA proposes a determination that these are unreasonable risks. EPA is proposing to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride for consumer and most types of commercial paint and coating removal under section 6 of the Toxic Substances Control Act (TSCA). EPA is also proposing to prohibit the use of methylene chloride in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping. EPA is proposing an initial ten-year time-limited exemption from these proposed regulations on methylene chloride for coating removal uses critical for national security. First, EPA is proposing to prohibit the manufacture (including import), processing, and distribution in commerce of NMP for all consumer and commercial paint and coating removal; to prohibit the use of NMP for all commercial paint and coating removal; to require, consistent with methylene chloride restrictions, downstream notification of these prohibitions throughout the supply chain; to require recordkeeping; and to provide a time-limited exemption from these proposed regulations on NMP for coating removal uses critical for national security. For NMP, as an alternate proposal, EPA is proposing that (1) commercial users of NMP for paint and coating removal establish a worker protection program for dermal and respiratory protection and not use paint and coating removal products that contain greater than 35% NMP by weight (except for product formulations destined to be used by DoD or its contractors performing work only for DOD projects); and (2) processors of products containing NMP for paint and coating removal reformulate products such that these products do not exceed a maximum of 35% NMP by weight, identify gloves that provide effective protection for the formulation, and provide warning and instruction labels on the products. </pre>

Products Covered: Methylene chloride and N-Methylpyrrolidone

Regulation Type: Regular notification

Submit your email ID to receive notifications about upcoming courses and events