Regulatory Updates
TITLE: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Final rule; delay of compliance dates; request for comments ; ; SUMMARY: The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of 17 June 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products. ; ; DATES: ; Effective Date: This final rule is effective 18 June 2012. The final rule published at 76 FR 35620 on 17 June 2011, remains effective 18 June 2012. ; ; Comment date: Submit written or electronic comments on the delay of compliance dates by 21 May 2012. ; ; Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on 17 June 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, 3 September 2004, are delayed until 17 December 2013, for products with annual sales of less than $25,000, and until 17 December 2012 for all other products subject to the rule. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/html/2012-11390.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/pdf/2012-11390.pdf ;
Distribution date: 23 May 2012
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
TITLE: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates ; ; AGENCY: Food and Drug Administration, Department of Health and Human Services ; ; ACTION: Final rule; delay of compliance dates; request for comments ; ; SUMMARY: The Food and Drug Administration (FDA) is delaying the compliance dates for the final rule for over-the-counter (OTC) sunscreen drug products that published in the Federal Register of 17 June 2011 (76 FR 35620). The final rule establishes labeling and effectiveness testing for certain OTC sunscreen products containing specified active ingredients and marketed without approved applications. It also amends labeling claims that are not currently supported by data and lifts the previously-published delay of implementation of the Drug Facts labeling requirements for OTC sunscreens. The 2011 final rule's compliance dates are being delayed because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule's requirements for all affected products will require an additional 6 months. This final rule is part of FDA's ongoing review of OTC drug products. ; ; DATES: ; Effective Date: This final rule is effective 18 June 2012. The final rule published at 76 FR 35620 on 17 June 2011, remains effective 18 June 2012. ; ; Comment date: Submit written or electronic comments on the delay of compliance dates by 21 May 2012. ; ; Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on 17 June 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, 3 September 2004, are delayed until 17 December 2013, for products with annual sales of less than $25,000, and until 17 December 2012 for all other products subject to the rule. ; ; URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/html/2012-11390.htm ; http://www.gpo.gov/fdsys/pkg/FR-2012-05-11/pdf/2012-11390.pdf ;
Distribution date: 23 May 2012
Products Covered: Sunscreen Drug Products (HS: 3304.10-99; ICS: 13, 71.100)
Regulation Type: Addendum to Regular Notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (revision of agricultural chemical residue standards).
Distribution date: 23 May 2012 | Final date for Comment: 22 July 2012
Proposed maximum residue limits (MRLs) for the following agricultural chemicals; - Pesticides: 2,6-Difluorobenzoic acid, N-(2-Ethylhexyl)-8,9,10-trinorborn-5-ene-2,3- dicarboximide, XMC, Allidochlor, Azafenidin, Bromochloromethane, Chlorefenson (CPCBS), Cinosulfuron, Cloprop, Copper terephthalate, Dichlone, Dimepiperate, Dimethametryn, Ethiofencarb, Etrimfos, Furametpyr, Halfenprox, Hexaflumuron, Isazofos, Naproanilide, Piperophos, Propaphos, Pyrifenox and Trichlamide - Veterinary drugs: Nalidixic acid, Parbendazole and Thiamphenicol
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: 03.01, 03,02, 03.03, 03.04, 03.05, 03.06 and 03.07) - 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, 07.12, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11, 08.13 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 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, 12.04, 12.05, 12.06, 12.07 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (revision of agricultural chemical residue standards).
Distribution date: 23 May 2012 | Final date for Comment: 22 July 2012
Proposed maximum residue limits (MRLs) for the following agricultural chemicals; - Pesticides: 2,6-Difluorobenzoic acid, N-(2-Ethylhexyl)-8,9,10-trinorborn-5-ene-2,3- dicarboximide, XMC, Allidochlor, Azafenidin, Bromochloromethane, Chlorefenson (CPCBS), Cinosulfuron, Cloprop, Copper terephthalate, Dichlone, Dimepiperate, Dimethametryn, Ethiofencarb, Etrimfos, Furametpyr, Halfenprox, Hexaflumuron, Isazofos, Naproanilide, Piperophos, Propaphos, Pyrifenox and Trichlamide - Veterinary drugs: Nalidixic acid, Parbendazole and Thiamphenicol
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: 03.01, 03,02, 03.03, 03.04, 03.05, 03.06 and 03.07) - 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, 07.12, 07.13 and 07.14) - Edible fruits and nuts, peel of citrus/melons (HS Codes: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10, 08.11, 08.13 and 08.14) - Coffee, tea, mate and spices (HS Codes: 09.01, 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, 12.04, 12.05, 12.06, 12.07 12.10 and 12.12) - Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02) - Cacao and cacao preparations (HS Code: 18.01)
Regulation Type: Regular notification
La República de Ecuador comunica con relación al Proyecto de Reglamento Técnico RTE INEN 066 Diluyentes (Thinner), notificado mediante el documento identificado con la signatura G/TBT/N/ECU/82 del 22 de noviembre de 2011, que éste ha sido expedido mediante la Resolución N° 13 083 del 29 de marzo de 2012, de la Subsecretaría de la Calidad del Ministerio de Industrias y Productividad, publicada en el Registro Oficial Nº 689 de 24 de abril de 2012. ; ; Texto disponible en el Ministerio de Industrias y Productividad, Subsecretaría de Comercio e Inversiones, Organismo Nacional encargado de la Notificación: ; ; Responsable: Arturo Barbosa G. ; Avda. Eloy Alfaro y Amazonas, 2º Piso, Edif. MAGAP ; Quito - Ecuador ; Tel: (+593-2) 2546690, Ext.284 ; Fax: (+593-2) 2504922 ; Punto de Contacto: abarbosa@mipro.gob.ec ; ;
Distribution date: 21 May 2012
Products Covered: 3814.00.90.00
Regulation Type: Addendum to Regular Notification
La República de Ecuador comunica con relación al Proyecto de Reglamento Técnico RTE INEN 066 Diluyentes (Thinner), notificado mediante el documento identificado con la signatura G/TBT/N/ECU/82 del 22 de noviembre de 2011, que éste ha sido expedido mediante la Resolución N° 13 083 del 29 de marzo de 2012, de la Subsecretaría de la Calidad del Ministerio de Industrias y Productividad, publicada en el Registro Oficial Nº 689 de 24 de abril de 2012. ; ; Texto disponible en el Ministerio de Industrias y Productividad, Subsecretaría de Comercio e Inversiones, Organismo Nacional encargado de la Notificación: ; ; Responsable: Arturo Barbosa G. ; Avda. Eloy Alfaro y Amazonas, 2º Piso, Edif. MAGAP ; Quito - Ecuador ; Tel: (+593-2) 2546690, Ext.284 ; Fax: (+593-2) 2504922 ; Punto de Contacto: abarbosa@mipro.gob.ec ; ;
Distribution date: 21 May 2012
Products Covered: 3814.00.90.00
Regulation Type: Addendum to Regular Notification
Resolución Directoral Nº 007-2012-AG-SENASA-DSV (Directorial Resolution No. 007-2012-AG-SENASA-DSV)
Distribution date: 09 May 2012
The notified Directorial Resolution establishes the mandatory phytosanitary requirements governing the importation of cultures of microorganisms (Rhizophagus irregularis, Rhizophagus clarus, Bacillus subtilis, and Bacillus amyloliquefaciens) from Belgium for research purposes.
Products Covered: Microorganisms (3002.90.10.00)
Regulation Type: Regular notification
Resolución Directoral Nº 007-2012-AG-SENASA-DSV (Directorial Resolution No. 007-2012-AG-SENASA-DSV)
Distribution date: 09 May 2012
The notified Directorial Resolution establishes the mandatory phytosanitary requirements governing the importation of cultures of microorganisms (Rhizophagus irregularis, Rhizophagus clarus, Bacillus subtilis, and Bacillus amyloliquefaciens) from Belgium for research purposes.
Products Covered: Microorganisms (3002.90.10.00)
Regulation Type: Regular notification
The European Union would like to inform the WTO Members that Commission Regulation (EU) No 223/2012 amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I and IV thereto to technical progress was adopted on 14 March 2012 and published in the Official Journal of the EU L 75 on 15 March 2012. ; ; The text of the Regulation is available on the EU-TBT website in English, French and Spanish: http://ec.europa.eu/enterprise/tbt/, and at ; ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:075:0012:0023:EN:PDF ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:075:0012:0023:FR:PDF ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:075:0012:0023:ES:PDF ; and in all the official languages of the EU at ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32012R0223:EN:NOT ;
Distribution date: 08 May 2012
Products Covered: Fertilisers (HS:31)
Regulation Type: Addendum to Regular Notification
The European Union would like to inform the WTO Members that Commission Regulation (EU) No 223/2012 amending Regulation (EC) No 2003/2003 of the European Parliament and of the Council relating to fertilisers for the purposes of adapting Annexes I and IV thereto to technical progress was adopted on 14 March 2012 and published in the Official Journal of the EU L 75 on 15 March 2012. ; ; The text of the Regulation is available on the EU-TBT website in English, French and Spanish: http://ec.europa.eu/enterprise/tbt/, and at ; ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:075:0012:0023:EN:PDF ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:075:0012:0023:FR:PDF ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:075:0012:0023:ES:PDF ; and in all the official languages of the EU at ; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32012R0223:EN:NOT ;
Distribution date: 08 May 2012
Products Covered: Fertilisers (HS:31)
Regulation Type: Addendum to Regular Notification
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