Regulatory Updates
TTS/CRS 54:2015, Specification for Cement (15 pages, in English)
Distribution date: 02 April 2015 | Final date for Comment: 15 May 2015
<p>This standard specifies requirements for hydraulic cements used primarily in the construction industry. It includes requirements for compressive strength, physical properties, chemical properties, packaging, labelling and the means of determining compliance to these requirements. </p><p>This standard applies to Portland and blended cement. </p>
Products Covered: Portland cement and similar hydraulic cements (ICS: 91.100.10, HS: 2523)
Regulation Type: Regular notification
Prohíbe registro, importación, exportación, fabricación, formulación, almacenamiento, distribución, transporte, reempaque, reenvase, manipulación, venta, mezcla y uso de ingredientes y plaguicidas sintéticos formulados que contengan aldicarb. Decreto Ejecutivo 38678-MAG-S-MINAE-MTSS (Ban on the registration, importation, exportation, manufacture, formulation, storage, distribution, transportation, repacking, repackaging, handling, sale, blending and use of ingredients and formulated synthetic pesticides containing aldicarb. Executive Decree No. 38678-MAG-S-MINAE-MTSS), published in Official Journal La Gaceta No. 223 of 19 November 2014
Distribution date: 27 March 2015
The purpose of the notified Decree is to prohibit the registration, importation, exportation, manufacture, formulation, storage, distribution, transportation, repacking, repackaging, handling, sale, blending and use of technical grade active ingredients and formulated synthetic pesticides containing the active ingredient aldicarb and to repeal Executive Decree No. 34147-S-MAG-TSS-MINAE.
Products Covered: Ingredients and formulated synthetic pesticides containing aldicarb.
Regulation Type: Regular notification
Prohibición del registro, importación, exportación, fabricación, formulación, almacenamiento, distribución, transporte, reempaque, reenvase, manipulación, venta, mezcla y uso de ingredientes activos grado técnico y plaguicidas sintéticos formulados que contengan el ingrediente activo carbofurán y derogatoria del Decreto Ejecutivo N° 34149-S-MAG-MTSS-MINAE (Ban on the registration, importation, exportation, manufacture, formulation, storage, distribution, transportation, repacking, repackaging, handling, sale, blending and use of technical grade active ingredients and formulated synthetic pesticides containing the active ingredient carbofuran and repeal of Executive Decree No. 34149-S-MAG-MTSS-MINAE)
Distribution date: 27 March 2015
The purpose of the notified Decree is to prohibit the registration, importation, exportation, manufacture, formulation, storage, distribution, transportation, repacking, repackaging, handling, sale, blending and use of technical grade active ingredients or formulated synthetic pesticides containing the active ingredient carbofuran.The use of carbofuran is prohibited for all crops and formulation types, except for registered products that are authorized for use in granular formulations for pineapple and banana crops, which may be used for a 24-month period, after which they will be completely banned.
Products Covered: HS Chapter 38: Miscellaneous chemical products. Technical grade active ingredients or formulated synthetic pesticides containing the active ingredient carbofuran.
Regulation Type: Regular notification
Fireworks - Batteries and Combinations (13 pages, in Chinese)
Distribution date: 24 March 2015
<span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">This </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">S</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">tandard specifies the terms and definitions, classification and categorization, safety and quality requirements, testing methods, inspection rule</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">s</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">, labelling, packing, transport</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">ation </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">and storage of the combinations and batteries of fireworks. This </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">S</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;mso-bidi-font-family:'Times New Roman';">tandard is applicable to the production and inspection of the combinations and batteries of fireworks. </span>
Products Covered: Fireworks and firecrackers (HS Code: 36041000)
Regulation Type: Regular notification
Labelling of Fireworks (16 pages, in Chinese)
Distribution date: 24 March 2015
<span style="font-family:'Verdana','sans-serif';font-size:9pt;">This </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;">S</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;">tandard specifies the labelling requirements of<span> </span>fireworks and firecracker products, sales </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;">package</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;"> and transportation packing. This </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;">S</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;">tandard is applicable to the labelling and inspection of fireworks</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;"> and firecracker</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;"> products</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;">,</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;"> sales </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;">package</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;"> and transportation packing.</span>
Products Covered: Fireworks and firecrackers (HS Code: 36041000)
Regulation Type: Regular notification
Fireworks - Display Shell (11 pages, in Chinese)
Distribution date: 24 March 2015
<span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">This standard specifies the terms and definitions, </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;">product </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">classification, </span><span class="longtext1"><span style="background:white;font-family:'Arial','sans-serif';font-size:10pt;mso-fareast-font-family:SimSun;mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">technical </span></span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">requirement</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;">s</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">, test method</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;">s</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">, inspection rule</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;">s</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">, </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;">and </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">storage and transportation requirements of </span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:10.5pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">display shell</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:10.5pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:ZH-CN;mso-bidi-language:AR-SA;">s</span><span style="font-family:'Verdana','sans-serif';font-size:9pt;mso-bidi-font-size:11.0pt;mso-fareast-font-family:SimSun;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;">. </span>
Products Covered: Fireworks and firecrackers (HS Code: 36041000)
Regulation Type: Regular notification
Packing for Fireworks (9 pages, in Chinese) ;
Distribution date: 24 March 2015 | Final date for Comment: 23 May 2015
<p>This standard applies to the packing of fireworks products other than black powder, pyrotechnic composition as well as the ignition fuse.</p>
Products Covered: Fireworks and firecrackers (HS Code: 36041000)
Regulation Type: Regular notification
<pre><p>TITLE: Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Notice</p><p>SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Current Good Manufacturing Practice Requirements for Combination Products." The guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products, including presenting general considerations for CGMP compliance as well as analysis of hypothetical scenarios.</p><p>DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by 30 March 2015.</p><p>URLs:</p></pre><p>http://www.gpo.gov/fdsys/pkg/FR-2015-01-27/html/2015-01410.htm </p><p>http://www.gpo.gov/fdsys/pkg/FR-2015-01-27/pdf/2015-01410.pdf</p>
Distribution date: 17 March 2015
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Addendum to Regular Notification
<pre><p>TITLE: Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period</p><p>AGENCY: Food and Drug Administration, HHS</p><p>ACTION: Notice; extension of comment period</p><p>SUMMARY: The Food and Drug Administration (FDA) is extending the comment period by 30 days to 29 April 2015, for the notice entitled "Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability," that appeared in the Federal Register of 27 January 2015 (80 FR 4280). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.</p><p>DATES: FDA is extending the comment period on the draft guidance. Submit either electronic or written comments by 29 April 2015.</p><p>URLs:</p></pre><p>http://www.gpo.gov/fdsys/pkg/FR-2015-03-13/html/2015-05674.htm </p><p>http://www.gpo.gov/fdsys/pkg/FR-2015-03-13/pdf/2015-05674.pdf</p>
Distribution date: 17 March 2015
Products Covered: Combination products (HS: 3004, 9018.11-90) (ICS: 71.100, 13.020)
Regulation Type: Addendum to Regular Notification
New Regulation 27B, Food Regulations 1985: Plastic Materials and Articles
Distribution date: 17 March 2015 | Final date for Comment: 16 May 2015
The regulation provides the maximum proportion of release of chemical substances and specific migration limit or total specific migration limit to ensure that plastic materials and articles that are intended to come into contact with food, already in contact with food or which can reasonably be expected to come into contact with food meet with the minimum safety requirements.
Products Covered: All food
Regulation Type: Regular notification
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