Projet de décret pris pour l'application de la loi n°28-07 relative à la sécurité sanitaire des produits alimentaires (Draft decree implementing Law No. 28-07 on food safety)

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Distribution date: 25 July 2011 | Final date for Comment: 10 August 2011

The notified text establishes:-Modalities for issuing, suspending and withdrawing sanitary authorization and approval and for controlling the conformity of food products, in accordance with Article 7 of Law No. 28-07;-health and hygiene requirements for establishments and companies and their staff, and for primary products, food products and means of transport covered by Article 8 of Law No. 28-07; requirements concerning cleaning and disinfectant products and physical, chemical and biological contamination levels;-rules for the implementation, by operators of establishments and companies in the food and animal food sectors, of self-control programmes and guidelines on good health practices, as provided for in Article 9 of Law No. 28-07;-requirements for the implementation of the provisions of Article 10 of Law No. 28-07 concerning the mandatory information to be provided by operators of establishments and companies in the food and animal food sectors;-modalities for the implementation of the traceability requirements set forth in Article 12 of Law No. 28-07.The notified Decree also establishes:-Modalities for the registration of the livestock farms concerned and technical requirements and modalities for the identification and monitoring of animals, as provided for in Articles 13 and 14 of Law No. 28-07;-establishment modalities and requirements for keeping maintenance and management registers for primary products of plant origin, as provided for in Article 15 of Law No. 28-07.

Products Covered: HS codes 01, 02, 03, 04, 05, 06, 07, 08, 09, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22 and 23.

Regulation Type: Regular notification

Food safety Traceability Human health

Draft Ecuadorian Technical Regulation of the Ecuadorian Standardization Institute (PRTEINEN) No. 061: "Paint" (13 pages, in Spanish)

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Distribution date: 25 July 2011 | Final date for Comment: 18 September 2011

Este Proyecto de Reglamento Técnico establece el objeto, campo de aplicación, definiciones, condiciones generales, requisitos, ensayos para evaluar la conformidad, rotulado, muestreo, documentos normativos consultados o de referencia, demostración del cumplimiento con el reglamento técnico ecuatoriano, organismos encargados de la evaluación y la certificación de la conformidad, autoridad de fiscalización y/o supervisión, tipo de fiscalización y/o supervisión, régimen de sanciones, responsabilidad de los organismos de evaluación de la conformidad y revisión y actualización del reglamento técnico, sobre "Pinturas".

Products Covered: 3208100000, 3208200000, 3208900000, 3209100000, 3209900000, 3210001000, 3210002000, 3210009000

Regulation Type: Regular notification

Human health

Draft Ecuadorian Technical Regulation of the Ecuadorian Standardization Institute (PRTEINEN) No. 061: "Paint" (13 pages, in Spanish)

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Distribution date: 25 July 2011 | Final date for Comment: 18 September 2011

Este Proyecto de Reglamento Técnico establece el objeto, campo de aplicación, definiciones, condiciones generales, requisitos, ensayos para evaluar la conformidad, rotulado, muestreo, documentos normativos consultados o de referencia, demostración del cumplimiento con el reglamento técnico ecuatoriano, organismos encargados de la evaluación y la certificación de la conformidad, autoridad de fiscalización y/o supervisión, tipo de fiscalización y/o supervisión, régimen de sanciones, responsabilidad de los organismos de evaluación de la conformidad y revisión y actualización del reglamento técnico, sobre "Pinturas".

Products Covered: 3208100000, 3208200000, 3208900000, 3209100000, 3209900000, 3210001000, 3210002000, 3210009000

Regulation Type: Regular notification

Human health

Draft Commission Regulation 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

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Distribution date: 25 July 2011 | Final date for Comment: 23 September 2011

The purposes of the legislative proposal are: ; o To allow the use of calcium borate, copper oxide and manganese oxide as ingredients for the manufacture of fertiliser suspensions. One chelating agent, one complexing agent, two nitrification inhibitors and one urease inhibitor are also proposed for inclusion in the respective lists of authorised substances. ; o To revise the rules for mixture of micro-nutrient fertilisers. ; o To introduce type designations to allow the use of authorised complexing agents listed in Section E.3.2. ; o To modify the rules for micronutrient solutions to allow the use of one complexing agent in such fertilisers. ; o To introduce reference to EN Standards to simplify legislation. ;

Products Covered: Fertilisers (HS:31)

Regulation Type: Regular notification

Draft Commission Regulation 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

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Distribution date: 25 July 2011 | Final date for Comment: 23 September 2011

The purposes of the legislative proposal are: ; o To allow the use of calcium borate, copper oxide and manganese oxide as ingredients for the manufacture of fertiliser suspensions. One chelating agent, one complexing agent, two nitrification inhibitors and one urease inhibitor are also proposed for inclusion in the respective lists of authorised substances. ; o To revise the rules for mixture of micro-nutrient fertilisers. ; o To introduce type designations to allow the use of authorised complexing agents listed in Section E.3.2. ; o To modify the rules for micronutrient solutions to allow the use of one complexing agent in such fertilisers. ; o To introduce reference to EN Standards to simplify legislation. ;

Products Covered: Fertilisers (HS:31)

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)

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Distribution date: 26 July 2011 | Final date for Comment: 24 September 2011

: Proposed maximum residue limits (MRLs) for agricultural chemicals pesticides: Ethychlozate, Oxyfluorfen, and Pymetrozine; veterinary drugs: Clavulanic acid and Prifinium.

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, bird's eggs and natural honey (HS Codes: 04.01,04.07, 04.08) 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 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, 12.04, 12.05, 12.06, 12.07, 12.08 and 12.12 Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02)

Regulation Type: Regular notification

Food safety Human health Pesticides Veterinary drugs Maximum residue limits (MRLs)

Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (revision of agricultural chemical residue standards)

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Distribution date: 26 July 2011 | Final date for Comment: 24 September 2011

: Proposed maximum residue limits (MRLs) for agricultural chemicals pesticides: Ethychlozate, Oxyfluorfen, and Pymetrozine; veterinary drugs: Clavulanic acid and Prifinium.

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, bird's eggs and natural honey (HS Codes: 04.01,04.07, 04.08) 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 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, 12.04, 12.05, 12.06, 12.07, 12.08 and 12.12 Animal or vegetable fats and oils (HS Codes: 15.01 and 15.02)

Regulation Type: Regular notification

Food safety Human health Pesticides Veterinary drugs Maximum residue limits (MRLs)

Nisso America, Inc.; Food Additive Permitted for Direct Addition to Food for Human Consumption; Hydroxypropyl Cellulose; FAP 0A4780

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Distribution date: 26 July 2011 | Final date for Comment: 15 August 2011

The Food and Drug Administration (FDA) is amending the food additive regulations for hydroxypropyl cellulose by lowering the minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements. This action is in response to a petition filed by Nisso America, Inc. This addendum concerns a notification of adoption, publication or entry into force of regulation. This final rule can be found in the Federal Register of 15 July 2011 at Federal Register: 15 July 2011 (Volume 76, Number 136) Rules and Regulations; Page 41687-41689 or online at http://www.gpo.gov/fdsys/pkg/FR-2011-07-15/pdf/2011-17928.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

Nisso America, Inc.; Food Additive Permitted for Direct Addition to Food for Human Consumption; Hydroxypropyl Cellulose; FAP 0A4780

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Distribution date: 26 July 2011 | Final date for Comment: 15 August 2011

The Food and Drug Administration (FDA) is amending the food additive regulations for hydroxypropyl cellulose by lowering the minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements. This action is in response to a petition filed by Nisso America, Inc. This addendum concerns a notification of adoption, publication or entry into force of regulation. This final rule can be found in the Federal Register of 15 July 2011 at Federal Register: 15 July 2011 (Volume 76, Number 136) Rules and Regulations; Page 41687-41689 or online at http://www.gpo.gov/fdsys/pkg/FR-2011-07-15/pdf/2011-17928.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Adoption/publication/entry into force of reg.

TITLE: Labeling for Bronchodilators To Treat Asthma; Cold, Cough, ; Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the- ; Counter Human Use ; ; AGENCY: Food and Drug Administration, HHS. ; ; ACTION: Final rule. ; ; SUMMARY: The Food and Drug Administration (FDA) is amending the final ; monograph (FM) for over-the-counter (OTC) bronchodilator drug products ; to add additional warnings (e.g., an ``Asthma alert'') and to revise ; the indications, warnings, and directions in the labeling of products ; containing the ingredients ephedrine, ephedrine hydrochloride, ; ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine ; hydrochloride, and racepinephrine hydrochloride. FDA is issuing this ; final rule after considering data and information submitted in response ; to the Agency's proposed labeling revisions for these products. This ; final rule is part of FDA's ongoing review of OTC drug products. ; ; DATES: ; ; Effective Date: This regulation is effective 23 January 2012. ; ; Compliance Date: The compliance date for all products, regardless ; of annual sales, is 23 January 2012. ; ; FULL TEXT URLs: ; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/html/2011-18347.htm ; http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18347.pdf ;

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Distribution date: 04 August 2011 | Final date for Comment: 14 May 2025

Products Covered: Human Drug Products  (HS Chapter 30; ICS 11.120)

Regulation Type: Addendum to Regular Notification

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