Partial amendment to the Minimum Requirements for Biological Products (1 pages in English).
Distribution date: 23 August 2013 | Final date for Comment: 20 September 2013
The Minimum Requirements for Biological Products is to be partially amended to add the standard for a blood product to be newly approved.
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
Testing and Inspection of Food and Drugs Act
Distribution date: 27 August 2013 | Final date for Comment: 09 May 2025
Testing laboratory management regulations under 6 different laws (including Food sanitation Act, Pharmaceutical Affairs Act, etc.) have been consolidated into a single Act. The key features of the new law are: - Establishment of 5-year master plan for food and drug testing performance improvement; - Designation and management of testing laboratories; - Establishment and operation of a laboratory data management system.
Products Covered: Testing laboratories (food, livestock product, drug, herbal medicine, medical device, cosmetics)
Regulation Type: Regular notification
Testing and Inspection of Food and Drugs Act
Distribution date: 27 August 2013 | Final date for Comment: 09 May 2025
Testing laboratory management regulations under 6 different laws (including Food sanitation Act, Pharmaceutical Affairs Act, etc.) have been consolidated into a single Act. The key features of the new law are: - Establishment of 5-year master plan for food and drug testing performance improvement; - Designation and management of testing laboratories; - Establishment and operation of a laboratory data management system.
Products Covered: Testing laboratories (food, livestock product, drug, herbal medicine, medical device, cosmetics)
Regulation Type: Regular notification
Draft of the Eurasian Economic Commission Collegium Decision on amendments to the Customs Union Commission Decision on application of international standards, recommendations and guidelines No. 721 as of 22 June 2011
Distribution date: 29 August 2013 | Final date for Comment: 09 May 2025
The document introduces amendments to adjust CU legislation to the WTO SPS Agreement. Point 2 of the CU Commission Decision No. 721 will be amended in accordance with Article 3.3 of the WTO SPS Agreement.
Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU No. 317 as of 18 June 2010; Common list of regulated products subject to quarantine control, adopted by the Customs Union Commission Decision on plant quarantine in the CU No. 318 as of 18 June 2010; Common list of goods subject to sanitary and epidemiological control, adopted by the Customs Union Commission Decision on application of sanitary measures in the CU No. 299 as of 28 May 2010.
Regulation Type: Regular notification
Draft of the Eurasian Economic Commission Collegium Decision on amendments to the Customs Union Commission Decision on application of international standards, recommendations and guidelines No. 721 as of 22 June 2011
Distribution date: 29 August 2013 | Final date for Comment: 09 May 2025
The document introduces amendments to adjust CU legislation to the WTO SPS Agreement. Point 2 of the CU Commission Decision No. 721 will be amended in accordance with Article 3.3 of the WTO SPS Agreement.
Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU No. 317 as of 18 June 2010; Common list of regulated products subject to quarantine control, adopted by the Customs Union Commission Decision on plant quarantine in the CU No. 318 as of 18 June 2010; Common list of goods subject to sanitary and epidemiological control, adopted by the Customs Union Commission Decision on application of sanitary measures in the CU No. 299 as of 28 May 2010.
Regulation Type: Regular notification
Feed additives
Distribution date: 30 August 2013 | Final date for Comment: 09 May 2025
Regulation (EC) No 1831/2003, notified in G/SPS/N/EEC/165/Add.1 (19 November 2003), provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or denying such authorisations. After the European Food Safety Authority evaluation of new information on 3-acetyl-2,5-dimethylthiophene, its authorisation as a feed additive is denied. This denial is enacted by "Commission Implementing Regulation (EU) No 796/2013 of 21 August 2013 concerning the denial of authorisation of the substance 3-acetyl-2,5-dimethylthiophene as a feed additive" [OJ L 224, 21 August 2013, pp. 4-5]. This substance 3-acetyl-2,5-dimethylthiophene was also withdrawn from the list of authorised flavouring substances used in food by "Commission Regulation (EU) No 545/2013 of 14 June 2013 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the flavouring substance 3-acetyl-2,5-dimethylthiophene" [OJ L 163, 15 June 2013, pp.15-16], notified in G/SPS/N/EU/13/Add.2. http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_e.pdf http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_f.pdf http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Feed additives
Distribution date: 30 August 2013 | Final date for Comment: 09 May 2025
Regulation (EC) No 1831/2003, notified in G/SPS/N/EEC/165/Add.1 (19 November 2003), provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or denying such authorisations. After the European Food Safety Authority evaluation of new information on 3-acetyl-2,5-dimethylthiophene, its authorisation as a feed additive is denied. This denial is enacted by "Commission Implementing Regulation (EU) No 796/2013 of 21 August 2013 concerning the denial of authorisation of the substance 3-acetyl-2,5-dimethylthiophene as a feed additive" [OJ L 224, 21 August 2013, pp. 4-5]. This substance 3-acetyl-2,5-dimethylthiophene was also withdrawn from the list of authorised flavouring substances used in food by "Commission Regulation (EU) No 545/2013 of 14 June 2013 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the flavouring substance 3-acetyl-2,5-dimethylthiophene" [OJ L 163, 15 June 2013, pp.15-16], notified in G/SPS/N/EU/13/Add.2. http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_e.pdf http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_f.pdf http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
<p>Pursuant to Government Code section 11346.8(c), notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the text of the proposed regulations which establish the process for identifying and prioritizing consumer products and their chemicals of concern, evaluating their alternatives, and imposing regulatory responses, by adding chapter 55 of division 4.5 of Title 22, California Code of Regulations, and amending the Table of Contents. A written comment period for these LATEST REVISIONS to the proposed regulations text has been established to commence on 23 August 2013, and close at 5:00 p.m. on 9 September 2013.</p><p>DTSC mailed the original text and made it available for public review and comment on 27 July 2012. A public hearing was held on 10 September 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days, and ended 11 October 2012. DTSC made post-hearing changes to the proposed regulations, which were mailed and made available for public review and comment on 29 January 2013. Written comments were accepted on these post-hearing changes through 28 February 2013. DTSC made additional post-hearing changes to the proposed regulations, which were mailed and made available for public review and comment on 10 April 2013. Written comments were accepted on these subsequent post-hearing changes through 25 April 2013.</p><p>DTSC submitted the final rulemaking package for these regulations to the Office ofAdministrative Law in July 2013. Based on feedback received from the Office of Administrative Law, DTSC has determined that the attached revisions to the proposed regulations are necessary as explained below:</p><p>(1) Section 69501.3(b) is added to require that documents submitted to DTSC under the regulations be in English and be provided in an electronic format accessible to DTSC.</p><p>This provision is necessary to ensure that the information provided to DTSC (on either a mandatory or a voluntary basis) can be reviewed, evaluated, and processed by DTSC as effectively and efficiently as possible. This provision is also necessary to provide each person submitting information to DTSC flexibility as to how the information is submitted as long as it is accessible to DTSC. This flexibility is provided in recognition of the fact that different persons will have different information-generating capabilities and formats.</p><p>(2) Section 69509.1(a) is added to require that DTSC review a trade secret claim for information submitted under the regulations, along with the information provided in support of the trade secret claim, before disclosing the information that is the subject of the trade secrecy claim.</p><p>This provision is necessary to ensure that DTSC does not release to the public information for which a valid trade secrecy claim has been filed; and, on the other hand, to ensure that information is not withheld from the public based upon an invalid trade secrecy claim. This is necessary to maximize transparency and public access to information submitted to DTSC under these regulations, while protecting validly claimed trade secrets.</p><p>(3) Section 69509.1(c) is added to specify that, if DTSC determines that the information submitted in support of a trade secrecy claim does not establish that the information claimed to be trade secret meets the definition of "trade secret", DTSC will notify the submitting party of its determination by certified mail. The notice will also inform the submitting party that thirty (30) days from the date of the notice of DTSC's determination, the information will be regarded as a public record subject to disclosure. This provision also provides that during the 30-day period the submitting party may seek judicial intervention by bringing an action for a preliminary injunction and/or declaratory relief to prevent d</p>
Distribution date: 11 September 2013 | Final date for Comment: 09 May 2025
Products Covered: Chemicals (HS Chapter 38; ICS 71.100)
Regulation Type: Addendum to Regular Notification
<p>Pursuant to Government Code section 11346.8(c), notice is hereby given that the Department of Toxic Substances Control (DTSC) has revised the text of the proposed regulations which establish the process for identifying and prioritizing consumer products and their chemicals of concern, evaluating their alternatives, and imposing regulatory responses, by adding chapter 55 of division 4.5 of Title 22, California Code of Regulations, and amending the Table of Contents. A written comment period for these LATEST REVISIONS to the proposed regulations text has been established to commence on 23 August 2013, and close at 5:00 p.m. on 9 September 2013.</p><p>DTSC mailed the original text and made it available for public review and comment on 27 July 2012. A public hearing was held on 10 September 2012, during which DTSC accepted written and oral testimony. In addition, written comments were accepted during the 45-day public comment period, which was extended by 30 days, and ended 11 October 2012. DTSC made post-hearing changes to the proposed regulations, which were mailed and made available for public review and comment on 29 January 2013. Written comments were accepted on these post-hearing changes through 28 February 2013. DTSC made additional post-hearing changes to the proposed regulations, which were mailed and made available for public review and comment on 10 April 2013. Written comments were accepted on these subsequent post-hearing changes through 25 April 2013.</p><p>DTSC submitted the final rulemaking package for these regulations to the Office ofAdministrative Law in July 2013. Based on feedback received from the Office of Administrative Law, DTSC has determined that the attached revisions to the proposed regulations are necessary as explained below:</p><p>(1) Section 69501.3(b) is added to require that documents submitted to DTSC under the regulations be in English and be provided in an electronic format accessible to DTSC.</p><p>This provision is necessary to ensure that the information provided to DTSC (on either a mandatory or a voluntary basis) can be reviewed, evaluated, and processed by DTSC as effectively and efficiently as possible. This provision is also necessary to provide each person submitting information to DTSC flexibility as to how the information is submitted as long as it is accessible to DTSC. This flexibility is provided in recognition of the fact that different persons will have different information-generating capabilities and formats.</p><p>(2) Section 69509.1(a) is added to require that DTSC review a trade secret claim for information submitted under the regulations, along with the information provided in support of the trade secret claim, before disclosing the information that is the subject of the trade secrecy claim.</p><p>This provision is necessary to ensure that DTSC does not release to the public information for which a valid trade secrecy claim has been filed; and, on the other hand, to ensure that information is not withheld from the public based upon an invalid trade secrecy claim. This is necessary to maximize transparency and public access to information submitted to DTSC under these regulations, while protecting validly claimed trade secrets.</p><p>(3) Section 69509.1(c) is added to specify that, if DTSC determines that the information submitted in support of a trade secrecy claim does not establish that the information claimed to be trade secret meets the definition of "trade secret", DTSC will notify the submitting party of its determination by certified mail. The notice will also inform the submitting party that thirty (30) days from the date of the notice of DTSC's determination, the information will be regarded as a public record subject to disclosure. This provision also provides that during the 30-day period the submitting party may seek judicial intervention by bringing an action for a preliminary injunction and/or declaratory relief to prevent d</p>
Distribution date: 11 September 2013 | Final date for Comment: 09 May 2025
Products Covered: Chemicals (HS Chapter 38; ICS 71.100)
Regulation Type: Addendum to Regular Notification
<p style="margin-left:0.5in;text-align:left;"><span style="font-size:13.5pt;font-family:'Times New Roman','serif';"></span></p><p style="margin-left:0.5in;text-align:left;"><span style="font-size:13.5pt;font-family:'Times New Roman','serif';"></span></p><p align="left" style="text-align:left;"><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>TITLE: Safer Consumer Product Alternatives</span></span></span></p><p align="left" style="text-align:left;"><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>AGENCY: Department of Toxic Substances Control (DTSC), State of California</span></span></span></p><p><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;font-family:'Verdana','sans-serif';">SUMMARY:</span></span><span style="font-size:13.5pt;font-family:'Times New Roman','serif';"><span style="font-size:x-small;"><span style="font-face:Verdana;"></span></span>Safer Consumer Products Regulations Effective 1 October 2013 (Approved by the Office of Administrative Law on 28 August 2013)</span></p><p style="text-align:left;"><span style="font-size:10.0pt;font-family:'Times New Roman','serif';">The Safer Consumer Products regulations were approved by the Office of Administrative Law (OAL) on 28 August 2013 (OAL File No. 2013-0718-03 S) and have been filed with the Secretary of State. The regulations will take effect on 1 October 2013. They require manufacturers or other responsible entities to seek safer alternatives to harmful chemical ingredients in widely used products, offering California the opportunity to lead the way in producing safer versions of goods already in demand around the world.</span></p><p align="left" style="text-align:left;"><span style="font-face:Verdana;font-size:x-small;"><span lang="EN-GB" style="font-size:9.0pt;"><span>For more information: <a href="http://www.dtsc.ca.gov/SCPRegulations.cfm">http://www.dtsc.ca.gov/SCPRegulations.cfm</a></span></span></span></p><p style="text-align:left;"><span style="font-size:10.0pt;font-family:'Times New Roman','serif';"></span></p> ; ;http://www.dtsc.ca.gov/LawsRegsPolicies/Regs/upload/Text-of-Final-Safer-Consumer-Products-Regulations-2.pdf
Distribution date: 11 September 2013 | Final date for Comment: 09 May 2025
Products Covered: Chemicals (HS Chapter 38; ICS 71.100)
Regulation Type: Addendum to Regular Notification
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