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
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
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
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

Distribution date: 09 December 2015 | Final date for Comment: 07 February 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Etofenprox.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.05 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

Distribution date: 09 December 2015 | Final date for Comment: 07 February 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Etofenprox.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Fish and crustaceans, molluscs and other aquatic invertebrates (HS Codes: 03.02, 03.03 and 03.04) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 07.04, 07.05, 07.06, 07.07, 07.08, 07.09, 07.10, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.02, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Codes: 10.01, 10.02, 10.03, 10.04, 10.05, 10.06, 10.07 and 10.08) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01, 12.02, 12.05 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

Distribution date: 09 December 2015 | Final date for Comment: 07 February 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Benzofenap.
Products Covered: Cereals (HS Code: 10.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (revision of agricultural chemical residue standards)

Distribution date: 09 December 2015 | Final date for Comment: 07 February 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Benzofenap.
Products Covered: Cereals (HS Code: 10.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

Distribution date: 09 December 2015 | Final date for Comment: 07 February 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Isoxaflutole.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.09, 07.10 and 07.13) - Cereals (HS Code: 10.05) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
Revision of the Standards and Specifications for Foods and Food Additives under the Food Sanitation Act (Revision of agricultural chemical residue standards)

Distribution date: 09 December 2015 | Final date for Comment: 07 February 2016
Proposed maximum residue limits (MRLs) for the following agricultural chemical: Pesticide: Isoxaflutole.
Products Covered: - Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.07, 02.08 and 02.09) - Dairy produce, birds' eggs and natural honey (HS Codes: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Codes: 07.09, 07.10 and 07.13) - Cereals (HS Code: 10.05) - Oleaginous fruits, miscellaneous grains, seeds and fruits (HS Codes: 12.01 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01, 15.02 and 15.06)
Regulation Type: Regular notification
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