Chemical Regulatory Updates – Latest Global Changes

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.For further information, please contact:TPKM-WTO/TBT Enquiry Point Bureau of Standards, Metrology and Inspection Ministry of Economic Affairs No. 4, Sec. 1, Jinan Rd. Zhongzheng Dist., Taipei City 100, Taiwan Tel: +(886 2) 2343-1813 Fax: +(886 2) 2343-1804 E-mail: <a href="mailto:[email protected]">[email protected]</a>

Distribution date: 13 February 2017 | Final date for Comment: 30 April 2025

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

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">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.Information about the consultation process can be found on the Department of Health website: <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>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.Australia welcomes views and contributions from trading partners in the consultation process. </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

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 | Final date for Comment: 30 April 2025

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

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. 0132016SA, 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 | Final date for Comment: 30 April 2025

Products Covered: PHARMACEUTICAL PRODUCTS (HS code(s): 30)

Regulation Type: Addendum to Regular Notification

TITLE: Trichloroethylene (TCE); Regulation of Certain Uses Under Toxic Substances Control Act; Extension of Comment PeriodsAGENCY: Environmental Protection Agency (EPA)ACTION: Proposed rule; extension of comment periodsSUMMARY: 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.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.

Distribution date: 20 February 2017 | Final date for Comment: 30 April 2025

Products Covered: Trichloroethylene (TCE)

Regulation Type: Addendum to Regular Notification

Draft Resolution No. 311, 15 February 2017 (7 pages, in Portuguese)

Distribution date: 22 February 2017 | Final date for Comment: 17 March 2017

This Draft Resolution proposes the implantation of the National Medicine Control System (NMCS) and the mechanisms and procedures for medicine track and tracing, besides other measures. These mechanisms and procedures for medicine track and tracing is applicable throughout the national territory. The provisions of this proposal apply to all medicines registered at the Brazilian Health Regulatory Agency (ANVISA). It is not applicable to serum and vaccines that are part of the National Immunization Program; radiopharmaceuticals; non-prescription medicaments; medicines included on the Programs of medicines for free distribution and individualized delivery control of the Ministry of Health; specific medicines and phytomedicines; free samples.Medicine track and tracing system establishes mechanisms and procedures that allow to recovery the medicine history, identify its current location and the last known destination.The bidimensional bar code is the technology used to capture, store and comunicate events related to medicine track and tracing on the NMCS and the DATAMIX is the adopted standard as established  on ISO/IEC 16022:2006. The owner of the medicine marketing authorization is responsible for the generation and inclusion of the Datamix on the comercial package, including data of  the Unique Medicine Identificiation (UMI) and other provisions established at RDC Nº 71 from 22 December 2009 (available at <a href="http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/res0071_22_12_2009.html">http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2009/res0071_22_12_2009.html</a>) and modified by the RDC Nº 26 from 16 June 2011 (available at http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2011/rdc0026_16_06_2011.pdf).Every transport package, from expedition at the marketing authorization owner, should have a unique identification code that allows identify the UMI inside it.Imported medicines may have the Datamix and serial code printed by the manufacture on the country of origin or by the owner of the authorization in Brazil. The option adopted should be informed to Anvisa at the process for the Import Licence. Each member at the medicine supply chain should store and transmit electronically the data regarding the events of the medicine under its responsibility.The technological specifications related to the NMCS procedures will be published as Normative Instruction before the end of the fourth month after the date of publishing of this technical regulation.This proposal revokes the Resolution RDC Nº 54 from 10 December 2013 (available at <a href="http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2013/rdc0054_10_12_2013.pdf">http://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2013/rdc0054_10_12_2013.pdf</a>) and the RDC Nº 114 from 29 September 2016 (available at <a href="http://portal.anvisa.gov.br/documents/10181/2718376/RDC_114_2016.pdf/823dbdb9-c11f-45fa-b313-220426e75fb0">http://portal.anvisa.gov.br/documents/10181/2718376/RDC_114_2016.pdf/823dbdb9-c11f-45fa-b313-220426e75fb0</a>)

Products Covered: Medicines

Regulation Type: Regular notification

Human health

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

Distribution date: 27 February 2017 | Final date for Comment: 28 April 2017

Proposed maximum residue limits (MRLs) for the following agricultural chemical: Veterinary drug: Melengestrol Acetate.

Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce and birds' eggs (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Food safety Veterinary drugs Maximum residue limits (MRLs)

DUS 1584:2017, Organic fertilizer - Specification. (16 pages, in English)

Distribution date: 27 February 2017 | Final date for Comment: 28 April 2017

Products Covered: Organic fertilizer.

Regulation Type: Regular notification

Proyecto de la Normativa Técnica Sanitaria Ecuatoriana para productos cosméticos, productos de higiene doméstica, productos absorbentes de higiene personal (Draft Ecuadorian Sanitary Technical Regulation on cosmetics, domestic hygiene products and absorbent personal hygiene products) (23 pages, in Spanish)

Distribution date: 27 February 2017 | Final date for Comment: 25 March 2017

The notified draft Ecuadorian Sanitary Technical Regulation covers the following: Purpose; Scope; Definitions; General considerations; Mandatory sanitary notification (NSO), procedure and amendments, recognition (mandatory sanitary notification procedure, amendments to mandatory sanitary notification, recognition of mandatory sanitary notification code); Circulation of samples of no commercial value; Certificate of free sale and export certificate; Operating permit; Donation of cosmetics, domestic hygiene products or absorbent personal hygiene products in the event of a health emergency; Good manufacturing practices (GMP); GMP certification procedure; Inspection service and GMP certification fees; Notification of changes to GMP certificate; GMP certificate; and Monitoring and inspection.

Products Covered: 3305.10.00.00

Regulation Type: Regular notification

Human health

DUS 1660:2017, Inorganic foliar fertilizer - Specification. (12 pages, in English)

Distribution date: 27 February 2017 | Final date for Comment: 28 April 2017

This Draft Uganda Standard specifies requirements and methods of sampling and test for inorganic foliarfertilizers.

Products Covered: Inorganic foliar fertilizer.

Regulation Type: Regular notification

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Ban on the testing of cosmetics on animals in Australia - Background Paper (8 pages, in English).

Draft Resolution No. 311, 15 February 2017 (7 pages, in Portuguese)

Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

DUS 1584:2017, Organic fertilizer - Specification. (16 pages, in English)

DUS 1660:2017, Inorganic foliar fertilizer - Specification. (12 pages, in English)