Regulatory Updates
Draft Amendment of the Official Specifications for Ordinary Fertilizers, etc. (2 pages, in English)
Distribution date: 09 November 2015 | Final date for Comment: 08 January 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana', sans-serif;font-size:9pt;">Official <span style="letter-spacing:-0.1pt;">Specifications</span> to be amend</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">ed </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">mixed sludge compound </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">fertilizer.</span></span></span></span></span>
Products Covered: Fertilizer (HS: 3101, 3103, 3105) or vegetable fertilizers, whether or not mixed together or chemically treated; fertilizers produced by the mixing or chemical treatment of animal or vegetable products. (HS 3101), Mineral or chemical fertilizers, phosphatic - HS 3103, Mineral or chemical fertilizers containing two or three of the fertilizing elements nitrogen, phosphorus and potassium; other fertilizers; goods of this Chapter in tablets or similar forms or in packages of a gross weight not exceeding 10 kg HS 3105.
Regulation Type: Regular notification
Draft Amendment of the Official Specifications for Ordinary Fertilizers, etc. (2 pages, in English)
Distribution date: 09 November 2015 | Final date for Comment: 08 January 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana', sans-serif;font-size:9pt;">Official <span style="letter-spacing:-0.1pt;">Specifications</span> to be amend</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">ed </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">mixed sludge compound </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;">fertilizer.</span></span></span></span></span>
Products Covered: Fertilizer (HS: 3101, 3103, 3105) or vegetable fertilizers, whether or not mixed together or chemically treated; fertilizers produced by the mixing or chemical treatment of animal or vegetable products. (HS 3101), Mineral or chemical fertilizers, phosphatic - HS 3103, Mineral or chemical fertilizers containing two or three of the fertilizing elements nitrogen, phosphorus and potassium; other fertilizers; goods of this Chapter in tablets or similar forms or in packages of a gross weight not exceeding 10 kg HS 3105.
Regulation Type: Regular notification
Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date; Final Rule
Distribution date: 30 October 2015
The Food and Drug Administration is confirming the effective date of 22 September 2015, for the final rule that appeared in the Federal Register of 21 August 2015, and that amended the color additive regulations to expand the permitted use of spirulina extract as a color additive to include use in coating formulations applied to dietary supplement and drug tablets and capsules. The effective date of final rule published in the Federal Register of 21 August 2015 (80 FR 50762), confirmed: 22 September 2015. http://members.wto.org/crnattachments/2015/SPS/USA/15_4410_00_e.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date; Final Rule
Distribution date: 30 October 2015
The Food and Drug Administration is confirming the effective date of 22 September 2015, for the final rule that appeared in the Federal Register of 21 August 2015, and that amended the color additive regulations to expand the permitted use of spirulina extract as a color additive to include use in coating formulations applied to dietary supplement and drug tablets and capsules. The effective date of final rule published in the Federal Register of 21 August 2015 (80 FR 50762), confirmed: 22 September 2015. http://members.wto.org/crnattachments/2015/SPS/USA/15_4410_00_e.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
National Standard of the P.R.C., General Requirements on Raw Materials of Oral Care Products (142 pages, in Chinese)
Distribution date: 29 October 2015 | Final date for Comment: 28 December 2015
<p>This standard specifies requirements for raw materials of oral care products.</p>
Products Covered: Raw materials of oral care products
Regulation Type: Revision to Regular Notification
National Standard of the P.R.C., General Requirements on Raw Materials of Oral Care Products (142 pages, in Chinese)
Distribution date: 29 October 2015 | Final date for Comment: 28 December 2015
<p>This standard specifies requirements for raw materials of oral care products.</p>
Products Covered: Raw materials of oral care products
Regulation Type: Revision to Regular Notification
Notice of Consultation - Prescription Drug List (PDL): Hyoscine Butylbromide (2 pages, in English and French)
Distribution date: 29 October 2015 | Final date for Comment: 28 December 2015
<p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to switch injectable Hyoscine butylbromide to prescription status from ethical status for human use by adding it to the Human Prescription Drug List (PDL). </span></span></p>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)
Regulation Type: Regular notification
Notice of Consultation - Prescription Drug List (PDL): Hyoscine Butylbromide (2 pages, in English and French)
Distribution date: 29 October 2015 | Final date for Comment: 28 December 2015
<p><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-size:9pt;">The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to switch injectable Hyoscine butylbromide to prescription status from ethical status for human use by adding it to the Human Prescription Drug List (PDL). </span></span></p>
Products Covered: Prescription status of medicinal ingredients for human use (ICS: 11.120; HS: 3004.90)
Regulation Type: Regular notification
Resolución Directoral establece cinco categorías de riesgo en función a la capacidad de vehiculizar agentes patógenos de enfermedades que representen riesgo para la salud pública y sanidad animal, a su nivel de procesamiento y uso (Directorial Resolution establishing five risk categories in accordance with capacity to transmit pathogens of diseases that pose a risk to human or animal health, degree of processing and use)
Distribution date: 26 October 2015
The notified Directorial Resolution establishes five risk categories in accordance with a product's capacity to transmit pathogens of diseases that pose a risk to human or animal health.
Products Covered: Multiple products
Regulation Type: Regular notification
Resolución Directoral establece cinco categorías de riesgo en función a la capacidad de vehiculizar agentes patógenos de enfermedades que representen riesgo para la salud pública y sanidad animal, a su nivel de procesamiento y uso (Directorial Resolution establishing five risk categories in accordance with capacity to transmit pathogens of diseases that pose a risk to human or animal health, degree of processing and use)
Distribution date: 26 October 2015
The notified Directorial Resolution establishes five risk categories in accordance with a product's capacity to transmit pathogens of diseases that pose a risk to human or animal health.
Products Covered: Multiple products
Regulation Type: Regular notification
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