Styrene Information and Research Center; Filing of Food Additive Petition; Notice of Petition

Distribution date: 16 June 2016 | Final date for Comment: 15 August 2016
The Food and Drug Administration has filed a petition, submitted by the Styrene Information and Research Center (SIRC), requesting that we amend our food additive regulations to no longer provide for the use of styrene as a synthetic flavoring substance and adjuvant in food because these uses of styrene have been abandoned.
Products Covered: HS Code(s): 29; ICS Code(s): 67; Synthetic flavoring food additives
Regulation Type: Regular notification
Specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption

Distribution date: 10 June 2016
The second proposal notified in G/SPS/N/EU/140 (7 July 2015) is now adopted as Commission Implementing Regulation (EU) 2016/759 of 28 April 2016 drawing up lists of third countries, parts of third countries and territories from which member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC (Text with EEA relevance) [OJ L 67, 14 May 2016, pp. 13-62]. The Regulation applies from 7 June 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption

Distribution date: 10 June 2016
The second proposal notified in G/SPS/N/EU/140 (7 July 2015) is now adopted as Commission Implementing Regulation (EU) 2016/759 of 28 April 2016 drawing up lists of third countries, parts of third countries and territories from which member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC (Text with EEA relevance) [OJ L 67, 14 May 2016, pp. 13-62]. The Regulation applies from 7 June 2016. http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_e.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_f.pdf http://members.wto.org/crnattachments/2016/SPS/EEC/16_2292_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Draft Law "On Plant Protection". Draft had been prepared based on the following EU legislation: - Council Directive 2000/29/EC "On protective measures against introduction into the Community of organisms harmful to plants or plants products and against their spread within the Community" - Regulation (EC) 1107/2009 of the European Parliament and of the Council "Concerning the placing of the plant protection products on the market ..."

Distribution date: 09 June 2016 | Final date for Comment: 08 August 2016
The purposes of this law are: To ban the entrance and spread of pests in the territory of Albania To protect plants and plant products from pests To protect the human and animal health and environment from the use of Plant Protection Products (PPP) To adapt plant protection legislation with EU This draft law has the following chapters: Chapter I: General Provisions Chapter II: Organization and performing of the plant protection Chapter III: Pest control (based on the Council Directive 2000/29/EC) Chapter IV: Phytosanitary service and quarantine inspection (based on the Council Directive 2000/29/EC) Chapter V: Plant protection products (based on the Regulation (EC) 1107/2009) Chapter VI: Administrative infringements Chapter VII: Final dispositions
Products Covered: Plant health, plant protection products, registration and marketing of plant protection products
Regulation Type: Regular notification
Draft Law "On Plant Protection". Draft had been prepared based on the following EU legislation: - Council Directive 2000/29/EC "On protective measures against introduction into the Community of organisms harmful to plants or plants products and against their spread within the Community" - Regulation (EC) 1107/2009 of the European Parliament and of the Council "Concerning the placing of the plant protection products on the market ..."

Distribution date: 09 June 2016 | Final date for Comment: 08 August 2016
The purposes of this law are: To ban the entrance and spread of pests in the territory of Albania To protect plants and plant products from pests To protect the human and animal health and environment from the use of Plant Protection Products (PPP) To adapt plant protection legislation with EU This draft law has the following chapters: Chapter I: General Provisions Chapter II: Organization and performing of the plant protection Chapter III: Pest control (based on the Council Directive 2000/29/EC) Chapter IV: Phytosanitary service and quarantine inspection (based on the Council Directive 2000/29/EC) Chapter V: Plant protection products (based on the Regulation (EC) 1107/2009) Chapter VI: Administrative infringements Chapter VII: Final dispositions
Products Covered: Plant health, plant protection products, registration and marketing of plant protection products
Regulation Type: Regular notification
; ; ;Mexican Official Standard NOM-073-SSA1-2015: Stability of drugs, medicaments and herbal remedies, published in the Mexican Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx/) on 7 June 2016. ;On 26 February 2015, the Ministry of Health published draft Mexican Official Standard PROY-NOM-073-SSA1-2014: Stability of drugs, medicaments and herbal remedies, in the Mexican Official Journal for public consultation. ;Any comments should be addressed to: ;Secretaría de Economía (Ministry of the Economy) ;Subsecretaría de Competitividad y Normatividad (Undersecretariat of Competitiveness and Standardization) ;Dirección General de Normas (General Directorate of Standards) ;Tel.: (+52) 55 5729-9100, Ext. 43244 ;Fax: (+52) 55 5520-9715 ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogomexicano-de-normas ;Email: [email protected] and/or [email protected] ;Text available at: http://dof.gob.mx/nota_detalle.php?codigo=5440183&fecha=07/06/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_2229_00_s.pdf ;

Distribution date: 09 June 2016
Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Essential oils, whether or not terpeneless, incl. concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, fixed oils, waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils (HS code(s): 3301)
Regulation Type: Addendum to Regular Notification
; ; ;Mexican Official Standard NOM-073-SSA1-2015: Stability of drugs, medicaments and herbal remedies, published in the Mexican Official Journal (Diario Oficial de la Federación) (http://www.dof.gob.mx/) on 7 June 2016. ;On 26 February 2015, the Ministry of Health published draft Mexican Official Standard PROY-NOM-073-SSA1-2014: Stability of drugs, medicaments and herbal remedies, in the Mexican Official Journal for public consultation. ;Any comments should be addressed to: ;Secretaría de Economía (Ministry of the Economy) ;Subsecretaría de Competitividad y Normatividad (Undersecretariat of Competitiveness and Standardization) ;Dirección General de Normas (General Directorate of Standards) ;Tel.: (+52) 55 5729-9100, Ext. 43244 ;Fax: (+52) 55 5520-9715 ;Website: http://www.economia.gob.mx/comunidad-negocios/normalizacion/catalogomexicano-de-normas ;Email: [email protected] and/or [email protected] ;Text available at: http://dof.gob.mx/nota_detalle.php?codigo=5440183&fecha=07/06/2016 ;https://members.wto.org/crnattachments/2016/TBT/MEX/16_2229_00_s.pdf ;

Distribution date: 09 June 2016
Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Essential oils, whether or not terpeneless, incl. concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, fixed oils, waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils (HS code(s): 3301)
Regulation Type: Addendum to Regular Notification
Amendment the Standards and Specifications for Foods and Food Additives

Distribution date: 07 June 2016
Revision of specifications for Asparaginase.
Products Covered: Food additive (Asparaginase)
Regulation Type: Regular notification
Amendment the Standards and Specifications for Foods and Food Additives

Distribution date: 07 June 2016
Revision of specifications for Asparaginase.
Products Covered: Food additive (Asparaginase)
Regulation Type: Regular notification
SI 562 part 2 - Safety of toys: Flammability (22 pages, in English; 5 pages, in Hebrew)

Distribution date: 02 June 2016 | Final date for Comment: 01 August 2016
<p style="margin-top:6pt;"><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"><span>Revision of the Mandatory Standard SI 562 part 2, dealing with the f</span></span></span>lammability<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;"> s</span></span><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;">afety aspects of toys</span></span><span lang="EN-GB"><span style="letter-spacing:-0.1pt;">. </span></span><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">This draft standard revision adopts the European Standard EN 71-2: July 2011 and A1: March 2014. The major changes included in this revision are due to the implementation of the first amendment to the adopted European Standard. In addition the standard's Hebrew section includes the following changes:</span></span></p><ul><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">Updates the normative references detailed in paragraph 2</span></span></li><li><span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">Adds to paragraph 4.3 a new </span></span>requirement that costumes shall be permanently marked also with a <span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="letter-spacing:-0.1pt;font-size:9pt;">Hebrew warning</span></span></li></ul><p><span lang="EN-GB">Both the old standard and this new revised standard will apply </span>for a period of 1 year <span lang="EN-GB">from publication in Israel Official Gazette. During this time product may be tested according to the old or the new revised standard.</span></p>
Products Covered: Toys (HS: 3213, 3305, 3407, 3604.90, 3926, Chapters 61 and 62, and 9501-9503; ICS: 13.220.40 and 97.200.50)
Regulation Type: Regular notification
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