Chemical Regulatory Updates – Latest Global Changes

SI 1296 part 4 - Domestic gas burning water heaters: Central heating boilers - Type C, B2, B3 and B5 boilers of nominal heat input not exceeding 70 kW (85 pages, in English; 6 pages, in Hebrew)

Distribution date: 01 June 2016 | Final date for Comment: 31 July 2016

Revision of the Mandatory Standard SI 1296 part 4, dealing with central heating boilers (Type C, B2, B3 and B5 boilers of nominal heat input not exceeding 70 kW). This draft standard revision adopts the European Standard EN 15502-2-1: October 2012, with a few changes that appear in the standard's Hebrew section as follow:<ul><li>Limits the standard's scope to boilers of nominal heat input not exceeding 70 kW</li><li>Adds references to Mandatory standards and regulations applies in Israel</li><li>Adds requirement for marking and instructions in Hebrew</li></ul>

Products Covered: Domestic gas burning water heaters

Regulation Type: Regular notification

SI 1296 part 4 - Domestic gas burning water heaters: Central heating boilers - Type C, B2, B3 and B5 boilers of nominal heat input not exceeding 70 kW (85 pages, in English; 6 pages, in Hebrew)

Distribution date: 01 June 2016 | Final date for Comment: 31 July 2016

Revision of the Mandatory Standard SI 1296 part 4, dealing with central heating boilers (Type C, B2, B3 and B5 boilers of nominal heat input not exceeding 70 kW). This draft standard revision adopts the European Standard EN 15502-2-1: October 2012, with a few changes that appear in the standard's Hebrew section as follow:<ul><li>Limits the standard's scope to boilers of nominal heat input not exceeding 70 kW</li><li>Adds references to Mandatory standards and regulations applies in Israel</li><li>Adds requirement for marking and instructions in Hebrew</li></ul>

Products Covered: Domestic gas burning water heaters

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

Revision of the Mandatory Standard SI 562 part 2, dealing with the flammability s<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. 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:<ul><li>Updates the normative references detailed in paragraph 2</li><li>Adds to paragraph 4.3 a new requirement that costumes shall be permanently marked also with a Hebrew warning</li></ul>Both the old standard and this new revised standard will apply for a period of 1 year from publication in Israel Official Gazette. During this time product may be tested according to the old or the new revised standard.

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

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

Revision of the Mandatory Standard SI 562 part 2, dealing with the flammability s<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. 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:<ul><li>Updates the normative references detailed in paragraph 2</li><li>Adds to paragraph 4.3 a new requirement that costumes shall be permanently marked also with a Hebrew warning</li></ul>Both the old standard and this new revised standard will apply for a period of 1 year from publication in Israel Official Gazette. During this time product may be tested according to the old or the new revised standard.

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

Amendment the Standards and Specifications for Foods and Food Additives

Distribution date: 07 June 2016 | Final date for Comment: 02 May 2025

Revision of specifications for Asparaginase.

Products Covered: Food additive (Asparaginase)

Regulation Type: Regular notification

Food safety Human health Food additives

Amendment the Standards and Specifications for Foods and Food Additives

Distribution date: 07 June 2016 | Final date for Comment: 02 May 2025

Revision of specifications for Asparaginase.

Products Covered: Food additive (Asparaginase)

Regulation Type: Regular notification

Food safety Human health Food additives

; ; ;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 | Final date for Comment: 02 May 2025

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 | Final date for Comment: 02 May 2025

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

Food safety Human health Pesticides Plant health Territory protection

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

Products Covered: Plant health, plant protection products, registration and marketing of plant protection products

Regulation Type: Regular notification

Food safety Human health Pesticides Plant health Territory protection

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SI 1296 part 4 - Domestic gas burning water heaters: Central heating boilers - Type C, B2, B3 and B5 boilers of nominal heat input not exceeding 70 kW (85 pages, in English; 6 pages, in Hebrew)

SI 1296 part 4 - Domestic gas burning water heaters: Central heating boilers - Type C, B2, B3 and B5 boilers of nominal heat input not exceeding 70 kW (85 pages, in English; 6 pages, in Hebrew)

SI 562 part 2 - Safety of toys: Flammability (22 pages, in English; 5 pages, in Hebrew)

SI 562 part 2 - Safety of toys: Flammability (22 pages, in English; 5 pages, in Hebrew)

Amendment the Standards and Specifications for Foods and Food Additives

Amendment the Standards and Specifications for Foods and Food Additives