Regulatory Updates

Proyecto de Reglamento Técnico Ecuatoriano RTE INEN 093, "Productos Cosméticos" (Draft Technical Regulation of the Ecuadorian Standardization Institute (RTE INEN) No. 093, "Cosmetics") (10 pages, in Spanish) ;

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Distribution date: 19 November 2013 | Final date for Comment: 18 January 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; Product requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00, and 3307.90.90.00. ;Perfumes and toilet waters (HS 330300); Lip make-up preparations (HS 330410); Eye make-up preparations (HS 330420); Manicure or pedicure preparations (HS 330430); Powders, whether or not compressed (HS 330491); Shampoos (HS 330510); Preparations for permanent waving or straightening (HS 330520); Hair lacquers (HS 330530); Other (HS 330590); Dentifrices (HS 330610); Other (HS 330690); Pre-shave, shaving or after-shave preparations (HS 330710); Personal deodorants and antiperspirants (HS 330720); Perfumed bath salts and other bath preparations (HS 330730); Other (HS 330790). ;

Regulation Type: Regular notification

Human health

Eurasian Economic Commission Council Decision on amendments of the Customs Union Commission Decision on Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010

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Distribution date: 15 November 2013

The Russian Federation notified draft of the Eurasian Economic Commission Council Decision on amendments of the Customs Union Commission Decision on Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010, in G/SPS/N/RUS/27 (8 July 2013). The Decision was adopted by the Collegium of the Eurasian Economic Commission on 29 October 2013 No. 244. The Decision will enter into on 5 December 2013. The publication was on 5 November 2013 at the Eurasian Economic Commission website: http://www.eurasiancommission.org/docs/Download.aspx?IsDlg=0&ID=4901&print=1 The relevant amendments were introduced to the CU legislation specifically to the Common veterinary (veterinary and sanitary) requirements for import and transfer between the CU Parties of live of Lumbricus for breeding. (Footnote: the Eurasian Economic Commission Council Decision on amendments of the Customs Union Commission Decision on Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010 should read as follows "the Eurasian Economic Commission Collegium Decision on amendments of the Customs Union Commission Decision on Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010")

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Eurasian Economic Commission Council Decision on amendments of the Customs Union Commission Decision on Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010

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Distribution date: 15 November 2013

The Russian Federation notified draft of the Eurasian Economic Commission Council Decision on amendments of the Customs Union Commission Decision on Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010, in G/SPS/N/RUS/27 (8 July 2013). The Decision was adopted by the Collegium of the Eurasian Economic Commission on 29 October 2013 No. 244. The Decision will enter into on 5 December 2013. The publication was on 5 November 2013 at the Eurasian Economic Commission website: http://www.eurasiancommission.org/docs/Download.aspx?IsDlg=0&ID=4901&print=1 The relevant amendments were introduced to the CU legislation specifically to the Common veterinary (veterinary and sanitary) requirements for import and transfer between the CU Parties of live of Lumbricus for breeding. (Footnote: the Eurasian Economic Commission Council Decision on amendments of the Customs Union Commission Decision on Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010 should read as follows "the Eurasian Economic Commission Collegium Decision on amendments of the Customs Union Commission Decision on Common veterinary (veterinary and sanitary) requirements No. 317 as of 18 June 2010")

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Kerosine (5 pages, in Hebrew).

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Distribution date: 15 November 2013 | Final date for Comment: 14 January 2014

<p>First&nbsp;amendment to the Mandatory Standard SI&nbsp;100. This amendment changes the following:</p><ul><li>Adds to paragraph 2 dealing with the normative references, a reference to several more international standards.</li><li>Replaces Table 1 of paragraph 3 dealing with the chemical and physical requirements and providing a reference to new test methods.</li></ul>

Products Covered: Kerosine

Regulation Type: Regular notification

Kerosine (5 pages, in Hebrew).

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Distribution date: 15 November 2013 | Final date for Comment: 14 January 2014

<p>First&nbsp;amendment to the Mandatory Standard SI&nbsp;100. This amendment changes the following:</p><ul><li>Adds to paragraph 2 dealing with the normative references, a reference to several more international standards.</li><li>Replaces Table 1 of paragraph 3 dealing with the chemical and physical requirements and providing a reference to new test methods.</li></ul>

Products Covered: Kerosine

Regulation Type: Regular notification

Proyecto de Reglamento Técnico Ecuatoriano PRTE INEN 088 "Agentes de Tensión Superficial" (Draft Technical Regulation of the Ecuadorian Standardization Institute (PRTE INEN) No. 088: "Surface tension agents") (6 pages, in Spanish) ;

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Distribution date: 14 November 2013 | Final date for Comment: 13 January 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; General conditions; Requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

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: Regular notification

Proyecto de Reglamento Técnico Ecuatoriano PRTE INEN 088 "Agentes de Tensión Superficial" (Draft Technical Regulation of the Ecuadorian Standardization Institute (PRTE INEN) No. 088: "Surface tension agents") (6 pages, in Spanish) ;

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Distribution date: 14 November 2013 | Final date for Comment: 13 January 2014

The notified draft Technical Regulation covers the following: Purpose; Scope; Definitions; General conditions; Requirements; Labelling requirements; Sampling; Conformity assessment tests; Reference documents; Conformity assessment procedure; Monitoring and inspection authority; Penalty regime; Liability of conformity assessment bodies; and Review and updating. ; ;

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: Regular notification

Ordinance Nº 53, 13 October 2013 (Instrução Normativa nº 53, de 23 de outubro de 2013) determines criteria for definitions, classification, establishment registration and importation of fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials. ; ; (34 pages, in Portuguese).

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Distribution date: 14 November 2013

<p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>T</span>echnical regulation and </span><span lang="EN-GB">assessment procedures </span></span><span lang="EN-GB">establishing </span><span lang="EN-GB">provisions, criteria, inspection and supervision for the production and trade of fertilizers, liming, inoculants, agricultural biofertilizers </span><span style="font-face:Verdana;">or secondary materials</span><span lang="EN-GB">.</span></p><span><span style="font-size:small;font-face:Verdana;"><span style="font-family:'Verdana', 'sans-serif';background:white;font-size:10pt;">It revokes Ordinance Nº. 10, 6 May 2004 and Ordinance Nº. 20, 2 June 2009</span></span></span><span style="color:blue;font-size:medium;font-face:Times New Roman;"><span style="font-family:'Times New Roman', 'serif';color:blue;font-size:12pt;"> </span></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span style="font-family:'Verdana', 'sans-serif';color:black;font-size:9pt;">(Instrução Normativa Nº 10, de 6 de maio de 2004 e a Instrução Normativa Nº 20, de 2 de junho de 2009).</span></span>

Products Covered: Fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials (HS 31)

Regulation Type: Regular notification

Ordinance Nº 53, 13 October 2013 (Instrução Normativa nº 53, de 23 de outubro de 2013) determines criteria for definitions, classification, establishment registration and importation of fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials. ; ; (34 pages, in Portuguese).

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Distribution date: 14 November 2013

<p style="margin:6pt 0cm;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;"><span>T</span>echnical regulation and </span><span lang="EN-GB">assessment procedures </span></span><span lang="EN-GB">establishing </span><span lang="EN-GB">provisions, criteria, inspection and supervision for the production and trade of fertilizers, liming, inoculants, agricultural biofertilizers </span><span style="font-face:Verdana;">or secondary materials</span><span lang="EN-GB">.</span></p><span><span style="font-size:small;font-face:Verdana;"><span style="font-family:'Verdana', 'sans-serif';background:white;font-size:10pt;">It revokes Ordinance Nº. 10, 6 May 2004 and Ordinance Nº. 20, 2 June 2009</span></span></span><span style="color:blue;font-size:medium;font-face:Times New Roman;"><span style="font-family:'Times New Roman', 'serif';color:blue;font-size:12pt;"> </span></span><span style="color:black;font-size:x-small;font-face:Verdana;"><span style="font-family:'Verdana', 'sans-serif';color:black;font-size:9pt;">(Instrução Normativa Nº 10, de 6 de maio de 2004 e a Instrução Normativa Nº 20, de 2 de junho de 2009).</span></span>

Products Covered: Fertilizers, liming, inoculants, agricultural biofertilizers or secondary materials (HS 31)

Regulation Type: Regular notification

Notice of Consultation - Prescription Drug List: Diclofenac (2 pages, in English; 2 pages, in French).

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Distribution date: 13 November 2013 | Final date for Comment: 12 January 2014

<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:Calibri;mso-bidi-font-family:'Times New Roman';mso-ansi-language:EN-GB;mso-fareast-language:EN-US;mso-bidi-language:AR-SA;mso-bidi-font-size:11.0pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to increase the non-prescription concentration of Diclofenac from 1% to 2% in topical preparations for human use.</span></span>

Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS 3004.90)

Regulation Type: Regular notification

Human health

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