Draft Commission Decision on the identification of bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP) as substances of very high concern according to Article 57(f) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4 pages, in English)

Distribution date: 11 December 2015 | Final date for Comment: 09 February 2016
<span style="font-size:x-small;font-face:Verdana;"><span style="font-family:'Verdana','sans-serif';font-size:9pt;">This draft Commission Decision aims at identifying DEHP, DBP, DDP and DIBP as substances having endocrine disrupting properties whose effects to human health give rise to an equivalent level of concern according to Article 57(f) of Regulation (EC) No 1907/2006 (REACH). </span></span>
Products Covered: Four chemical substances: ; bis(2-ethylhexyl) phthalate (DEHP), (EC No. 204-211-0, CAS No. 117-81-7, HS code 2917.32), ; dibutyl phthalate (DBP) (EC No. 201-557-4, CAS No. 84-74-2, HS code 2917.34), ; benzyl butyl phthalate (BBP) (EC No. 201-622-7, CAS No. 85-68-7, HS code 2917.34) and ; diisobutyl phthalate (DIBP) (EC No. 201-553-2, CAS No. 84-69-5, HS code 2917.34)
Regulation Type: Regular notification
Proyecto de Reglamento que regula la intercambiabilidad de medicamentos (Draft Regulation on the interchangeability of medicines) (16 pages, in Spanish) ;

Distribution date: 14 December 2015 | Final date for Comment: 12 February 2016
The notified draft Regulation contains 4 titles, 26 articles, 12 final supplementary provisions and 1 annex, and establishes the regulatory provisions of Law No. 29459 - Law on pharmaceutical products, medical devices and sanitary products, in order to regulate the interchangeability of medicines. ; ;
Products Covered: Pharmaceutical products: Medicines, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;
Regulation Type: Regular notification
Proyecto de Reglamento que regula la intercambiabilidad de medicamentos (Draft Regulation on the interchangeability of medicines) (16 pages, in Spanish) ;

Distribution date: 14 December 2015 | Final date for Comment: 12 February 2016
The notified draft Regulation contains 4 titles, 26 articles, 12 final supplementary provisions and 1 annex, and establishes the regulatory provisions of Law No. 29459 - Law on pharmaceutical products, medical devices and sanitary products, in order to regulate the interchangeability of medicines. ; ;
Products Covered: Pharmaceutical products: Medicines, classified under Chapter 30 of the Harmonized System or Customs Tariff. ;
Regulation Type: Regular notification
Amendment to the Enforcement Order of Industrial Safety and Health Act and related ordinances about the 27 substances (1 page, in English)

Distribution date: 15 December 2015 | Final date for Comment: 13 February 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;">The Enforcement Order of Industrial Safety and Health </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">Act </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">and related ordinances are to be partially amended to place obligations on the business operators relating to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">the 27 substances</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">.</span></span></span></span></span></span>
Products Covered: Acetylacetone, Aluminum metal (HS 76), Aluminiumtrifluoride (HS 2826.12), 1-Bromopropane, 3-Bromo-1-propene, Butene (HS 2901.23), Chloroacetic acid (HS 2915.40), Dichloroacetic acid (HS 2915.40), Diethylene glycol monobutyl ether (HS 2909.43), Dimethy=2,2,2-trichloro-1-hydroxyethylphosphonate, Ethylene (HS 2901.21), Ethylene glycol monobutyl ether acetate, hexafluoro-1-Propene, Isobutyl nitrite, Iodides, Methyl naphthalene, 2-Methyl-5-nitroaniline, 1-Methyl-2-pyrrolidone, N,N-Diethylhydroxylamine, N-Vinyl-2-pyrrolidone, O-3-Chloro-4-methylcoumarin-7-ylO,O-diethylphosphorothioate, Perfluorooctanoic acid, 1-Propene (HS 2901.22), Propionaldehyde, Sodiumdihydridobis(2-methoxyethanolato)aluminate(1-), Tetrahydromethylphtalicanhydride, Trisodiumhexafluoroaluminate and preparations containing them (hereinafter referred to as the 27 substances )
Regulation Type: Regular notification
Amendment to the Enforcement Order of Industrial Safety and Health Act and related ordinances about the 27 substances (1 page, in English)

Distribution date: 15 December 2015 | Final date for Comment: 13 February 2016
<span style="font-size:x-small;font-face:Verdana;"><span lang="EN-GB" style="font-family:'Verdana','sans-serif';font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;">The Enforcement Order of Industrial Safety and Health </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">Act </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">and related ordinances are to be partially amended to place obligations on the business operators relating to </span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:JA;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">the 27 substances</span><span style="font-size:x-small;"><span lang="EN-GB" style="font-size:9pt;mso-fareast-font-family:'?? ??';mso-ansi-language:EN-GB;mso-fareast-language:EN-GB;mso-bidi-language:AR-SA;mso-bidi-font-family:'Times New Roman';mso-bidi-font-size:11.0pt;mso-ascii-font-family:Verdana;mso-hansi-font-family:Verdana;">.</span></span></span></span></span></span>
Products Covered: Acetylacetone, Aluminum metal (HS 76), Aluminiumtrifluoride (HS 2826.12), 1-Bromopropane, 3-Bromo-1-propene, Butene (HS 2901.23), Chloroacetic acid (HS 2915.40), Dichloroacetic acid (HS 2915.40), Diethylene glycol monobutyl ether (HS 2909.43), Dimethy=2,2,2-trichloro-1-hydroxyethylphosphonate, Ethylene (HS 2901.21), Ethylene glycol monobutyl ether acetate, hexafluoro-1-Propene, Isobutyl nitrite, Iodides, Methyl naphthalene, 2-Methyl-5-nitroaniline, 1-Methyl-2-pyrrolidone, N,N-Diethylhydroxylamine, N-Vinyl-2-pyrrolidone, O-3-Chloro-4-methylcoumarin-7-ylO,O-diethylphosphorothioate, Perfluorooctanoic acid, 1-Propene (HS 2901.22), Propionaldehyde, Sodiumdihydridobis(2-methoxyethanolato)aluminate(1-), Tetrahydromethylphtalicanhydride, Trisodiumhexafluoroaluminate and preparations containing them (hereinafter referred to as the 27 substances )
Regulation Type: Regular notification
<p>In the notification G/TBT/N/EU/329 , Item 4 should read:</p><p>Four chemical substances:</p><ul><li>bis(2-ethylhexyl) phthalate (DEHP), (EC No. 204-211-0, CAS No. 117-81-7, HS code 2917.32)</li><li>dibutyl phthalate (DBP) (EC No. 201-557-4, CAS No. 84-74-2, HS code 2917.34)</li><li>benzyl butyl phthalate (BBP) (EC No. 201-622-7, CAS No. 85-68-7, HS code 2917.34) and</li><li>diisobutyl phthalate (DIBP) (EC No. 201-553-2, CAS No. 84-69-5, HS code 2917.34) </li></ul>

Distribution date: 16 December 2015 | Final date for Comment: 04 May 2025
Products Covered: Four chemical substances: ; bis(2-ethylhexyl) phthalate (DEHP), (EC No. 204-211-0, CAS No. 117-81-7, HS code 2917.32), ; dibutyl phthalate (DBP) (EC No. 201-557-4, CAS No. 84-74-2, HS code 2917.34), ; benzyl butyl phthalate (BBP) (EC No. 201-622-7, CAS No. 85-68-7, HS code 2917.34) and ; diisobutyl phthalate (DIBP) (EC No. 201-553-2, CAS No. 84-69-5, HS code 2917.34)
Regulation Type: Corrigendum to Regular Notification
<p>In the notification G/TBT/N/EU/329 , Item 4 should read:</p><p>Four chemical substances:</p><ul><li>bis(2-ethylhexyl) phthalate (DEHP), (EC No. 204-211-0, CAS No. 117-81-7, HS code 2917.32)</li><li>dibutyl phthalate (DBP) (EC No. 201-557-4, CAS No. 84-74-2, HS code 2917.34)</li><li>benzyl butyl phthalate (BBP) (EC No. 201-622-7, CAS No. 85-68-7, HS code 2917.34) and</li><li>diisobutyl phthalate (DIBP) (EC No. 201-553-2, CAS No. 84-69-5, HS code 2917.34) </li></ul>

Distribution date: 16 December 2015 | Final date for Comment: 04 May 2025
Products Covered: Four chemical substances: ; bis(2-ethylhexyl) phthalate (DEHP), (EC No. 204-211-0, CAS No. 117-81-7, HS code 2917.32), ; dibutyl phthalate (DBP) (EC No. 201-557-4, CAS No. 84-74-2, HS code 2917.34), ; benzyl butyl phthalate (BBP) (EC No. 201-622-7, CAS No. 85-68-7, HS code 2917.34) and ; diisobutyl phthalate (DIBP) (EC No. 201-553-2, CAS No. 84-69-5, HS code 2917.34)
Regulation Type: Corrigendum to Regular Notification
Draft Regulation of the Minister of Agriculture concerning Animal Quarantine Actions for the Importation of Carcass, Meat, and/or Offal Into the Territory of the Republic of Indonesia

Distribution date: 04 January 2016 | Final date for Comment: 04 March 2016
This draft regulation is implementation of Article 41B paragraph (2) of Law No. 41/2014 concerning Amendment of Law No. 18/2009 on Livestock and Animal Health, and Article 7 paragraph (3) of Government Regulation No. 82/2000 concerning Animal Quarantine. The scope of this regulation includes: 1. Quarantine requirements for importation of carcass, meat and/or offal into the territory of Indonesia; 2. Quarantine actions; 3. Other provisions. I. Quarantine Requirements The Importation of carcasses, meat and/or offal into the territory of Indonesia shall meet the quarantine requirements as follows: a. Accompanied by a sanitary certificate issued by an competent authority in the country of origin or transit country; b. Shall be imported through the designated point of entry; c. Shall meet the technical requirements of the animal health; and d. Shall be notified and presented to the quarantine officer at the point of entry for quarantine actions. Sanitary Certificate Sanitary certificate shall contain at least the following information: 1. Product identity a. Kind and quantity; b. Country of origin; c. Registration number of production place from origin country; d. Recommendation number and import permit; e. Date of production; and f. Halal label. 2. Name and address of sender and receiver 3. Transportation/shipment information a. Type and identity of the means of conveyance; b. Country/Region of origin; c. Country/Region of destination; d. Estimated time of arrival/departure; e. Entry/Exit point; and f. Transit Point. 4. Declaration a. Carcass, meat and/or offal are free from animal quarantine pests and diseases (HPHK); b. Safe and suitable for human consumption; c. Laboratory result of biological and chemical hazard from appointed laboratory. 5. Technical requirement of the animal health a. Kind of carcass, meat and/or offal with HS code must be compatible to import permit; b. From country and establishment unit approved by Minister; c. Meet the shipment, transit and/or transshipment requirement; d. Meet the packing, labeling and temperature requirement. II. Quarantine Action 1. General a. Carcass, meat and/or offal imported into Indonesia shall be subject to quarantine action; b. Quarantine action carried out in form of examination, isolation, observation, treatment, detention, rejection, destruction and release; c. Quarantine action for carcass, meat and/or offal which hazardous to people shall be coordinated with institution in charge of veterinary and zoological public health service; d. Quarantine action shall be performed at entry point but if not possible, quarantine action can be performed at quarantine installation; e. Examination shall be performed in order to recognize completeness and validity of the sanitary certificate, halal certificate, temperature recording, and physical examination; f. If imported carcass, meat and/or offal has not accompanied by sanitation certificate, the carrier shall be rejected. 2. Importation of carcass, meat and/or offal from country or zone within a country a. In the case of importation of carcasses and meat from a country or zone within a country, must be carried out quarantine measures in the country of origin prior to importation into Indonesia; b. Quarantine measures in the country of origin carried out in the form of an examination of compliance of health requirements set by Indonesia. 3. Quarantine action of carcass, meat and/or offal for feed a. Carcass, meat and/or offal for feed shall be subject to quarantine action; b. Carcass, meat and/or offal for feed shall be: coloured with colour that safe for animal, marked unfit for human consumption on the packaging, transported in separated containers with the carcass, meat and/or offal for human consumption. 4. Other Provision This Law shall come into effect on the date of enactment.
Products Covered: Carcasses, meat and/or offal
Regulation Type: Regular notification
Draft Regulation of the Minister of Agriculture concerning Animal Quarantine Actions for the Importation of Carcass, Meat, and/or Offal Into the Territory of the Republic of Indonesia

Distribution date: 04 January 2016 | Final date for Comment: 04 March 2016
This draft regulation is implementation of Article 41B paragraph (2) of Law No. 41/2014 concerning Amendment of Law No. 18/2009 on Livestock and Animal Health, and Article 7 paragraph (3) of Government Regulation No. 82/2000 concerning Animal Quarantine. The scope of this regulation includes: 1. Quarantine requirements for importation of carcass, meat and/or offal into the territory of Indonesia; 2. Quarantine actions; 3. Other provisions. I. Quarantine Requirements The Importation of carcasses, meat and/or offal into the territory of Indonesia shall meet the quarantine requirements as follows: a. Accompanied by a sanitary certificate issued by an competent authority in the country of origin or transit country; b. Shall be imported through the designated point of entry; c. Shall meet the technical requirements of the animal health; and d. Shall be notified and presented to the quarantine officer at the point of entry for quarantine actions. Sanitary Certificate Sanitary certificate shall contain at least the following information: 1. Product identity a. Kind and quantity; b. Country of origin; c. Registration number of production place from origin country; d. Recommendation number and import permit; e. Date of production; and f. Halal label. 2. Name and address of sender and receiver 3. Transportation/shipment information a. Type and identity of the means of conveyance; b. Country/Region of origin; c. Country/Region of destination; d. Estimated time of arrival/departure; e. Entry/Exit point; and f. Transit Point. 4. Declaration a. Carcass, meat and/or offal are free from animal quarantine pests and diseases (HPHK); b. Safe and suitable for human consumption; c. Laboratory result of biological and chemical hazard from appointed laboratory. 5. Technical requirement of the animal health a. Kind of carcass, meat and/or offal with HS code must be compatible to import permit; b. From country and establishment unit approved by Minister; c. Meet the shipment, transit and/or transshipment requirement; d. Meet the packing, labeling and temperature requirement. II. Quarantine Action 1. General a. Carcass, meat and/or offal imported into Indonesia shall be subject to quarantine action; b. Quarantine action carried out in form of examination, isolation, observation, treatment, detention, rejection, destruction and release; c. Quarantine action for carcass, meat and/or offal which hazardous to people shall be coordinated with institution in charge of veterinary and zoological public health service; d. Quarantine action shall be performed at entry point but if not possible, quarantine action can be performed at quarantine installation; e. Examination shall be performed in order to recognize completeness and validity of the sanitary certificate, halal certificate, temperature recording, and physical examination; f. If imported carcass, meat and/or offal has not accompanied by sanitation certificate, the carrier shall be rejected. 2. Importation of carcass, meat and/or offal from country or zone within a country a. In the case of importation of carcasses and meat from a country or zone within a country, must be carried out quarantine measures in the country of origin prior to importation into Indonesia; b. Quarantine measures in the country of origin carried out in the form of an examination of compliance of health requirements set by Indonesia. 3. Quarantine action of carcass, meat and/or offal for feed a. Carcass, meat and/or offal for feed shall be subject to quarantine action; b. Carcass, meat and/or offal for feed shall be: coloured with colour that safe for animal, marked unfit for human consumption on the packaging, transported in separated containers with the carcass, meat and/or offal for human consumption. 4. Other Provision This Law shall come into effect on the date of enactment.
Products Covered: Carcasses, meat and/or offal
Regulation Type: Regular notification
Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff; Filing of Food Additive Petition; Notice of Petition

Distribution date: 06 January 2016 | Final date for Comment: 04 March 2016
The Food and Drug Administration has filed a petition, submitted by the Center for Science in the Public Interest, Natural Resources Defense Council, Center for Food Safety, Consumers Union, Improving Kids' Environment, Center for Environmental Health, Environmental Working Group, Environmental Defense Fund, and James Huff, proposing that the food additive regulations be amended to no longer authorize the use of seven listed synthetic flavoring food additives and to establish zero tolerances for the additives. The food additive petition was filed on 17 August 2015.
Products Covered: HS Code(s): 29; ICS Code(s): 67 Synthetic flavoring food additives
Regulation Type: Regular notification
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