Regulatory Updates

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

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Distribution date: 28 November 2014 | Final date for Comment: 27 January 2015

Proposed maximum residue limits (MRLs) for the following agricultural chemical - Pesticide: Etofenprox

Products Covered: - Meat and edible meat offal (HS Code: 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 Code: 03.02, 03.03 and 03.04) - Dairy produce, birds' eggs and natural honey (HS Code: 04.01, 04.07 and 04.08) - Products of animal origin (HS Code: 05.04) - Edible vegetables and certain roots and tubers (HS Code: 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 Code: 08.01, 08.02, 08.03, 08.04, 08.05, 08.06, 08.07, 08.08, 08.09, 08.10 and 08.14) - Coffee, tea, mate and spices (HS Code: 09.02, 09.03, 09.04, 09.05, 09.06, 09.07, 09.08, 09.09 and 09.10) - Cereals (HS Code: 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 Code: 12.01, 12.02, 12.05 and 12.12) - Animal or vegetable fats and oils (HS Code: 15.01, 15.02 and 15.06)

Regulation Type: Regular notification

Human health Pesticides Maximum residue limits (MRLs) Food safety

; ; ;By means of this Addendum No. 3, the Republic of Ecuador advises that Emergency Technical Regulation (RTE) No. 093 "Cosmetic products" of the Ecuadorian Standardization Institute (INEN), notified in document G/TBT/N/ECU/116 of 22 November 2013, has been issued pursuant to Resolution No. 14 476 of 18 November 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 381 of Monday 24 November 2014. ; ;Text available from: ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: (+593-2) 394-8760, Ext. 2358 / 2255 ;Email: [email protected] / [email protected] ; ;

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Distribution date: 27 November 2014

Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00 and 3307.90.90.00 ;

Regulation Type: Addendum to Regular Notification

; ; ;By means of this Addendum No. 3, the Republic of Ecuador advises that Emergency Technical Regulation (RTE) No. 093 "Cosmetic products" of the Ecuadorian Standardization Institute (INEN), notified in document G/TBT/N/ECU/116 of 22 November 2013, has been issued pursuant to Resolution No. 14 476 of 18 November 2014 of the Under-Secretariat for Quality of the Ministry of Industry and Productivity, published in Official Journal No. 381 of Monday 24 November 2014. ; ;Text available from: ;Ministerio de Industrias y Productividad (Ministry of Industry and Productivity) ;Subsecretaría de la Calidad (Under-Secretariat for Quality) ;Organismo Nacional encargado de la Notificación (National Notification Authority) ; ;Contact person: Marlon Martínez B. ;Yánez Pinzón No. 26-12 y Av. Colón, Edf. Rigel ;Quito, Ecuador ;Tel.: (+593-2) 394-8760, Ext. 2358 / 2255 ;Email: [email protected] / [email protected] ; ;

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Distribution date: 27 November 2014

Products Covered: 3303.00.00.00, 3304.10.00.00, 3304.20.00.00, 3304.30.00.00, 3304.91.00.00, 3305.10.00.00, 3305.20.00.00, 3305.30.00.00, 3305.90.00.00, 3306.10.00.00, 3306.90.00.00, 3307.10.00.00, 3307.20.00.00, 3307.30.00.00 and 3307.90.90.00 ;

Regulation Type: Addendum to Regular Notification

Draft of Sanitation Standard for Food Cleansers

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Distribution date: 24 November 2014 | Final date for Comment: 23 January 2015

The draft re-amends the standard for the substances which are used to disinfect or clean food and food-contact surfaces in food utensils, food containers and food packaging.

Products Covered: Food cleansers

Regulation Type: Revision to Regular Notification

Human health Food safety Contaminants

Draft of Sanitation Standard for Food Cleansers

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Distribution date: 24 November 2014 | Final date for Comment: 23 January 2015

The draft re-amends the standard for the substances which are used to disinfect or clean food and food-contact surfaces in food utensils, food containers and food packaging.

Products Covered: Food cleansers

Regulation Type: Revision to Regular Notification

Human health Food safety Contaminants

Proyecto de Directiva Sanitaria que regula las condiciones para la presentación de los resultados de control de calidad del primer lote y subsiguientes lotes de los productos farmacéuticos y dispositivos médicos (Draft Health Directive laying down requirements for the submission of quality control results for the first and subsequent batches of pharmaceutical products and medical devices) (7 pages, in Spanish) ;

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Distribution date: 19 November 2014 | Final date for Comment: 09 February 2015

The draft Health Directive contains nine titles and two annexes, and establishes quality control verification and phasing-in requirements for the first and subsequent batches of pharmaceutical products and medical devices prior to marketing or distribution in the Peruvian market. ; ;

Products Covered: ;- Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products. ;- Medical devices ;These products are classified under Chapter 30 of the Harmonized System or Customs Tariff. ;

Regulation Type: Regular notification

Human health

Proyecto de Directiva Sanitaria que regula las condiciones para la presentación de los resultados de control de calidad del primer lote y subsiguientes lotes de los productos farmacéuticos y dispositivos médicos (Draft Health Directive laying down requirements for the submission of quality control results for the first and subsequent batches of pharmaceutical products and medical devices) (7 pages, in Spanish) ;

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Distribution date: 19 November 2014 | Final date for Comment: 09 February 2015

The draft Health Directive contains nine titles and two annexes, and establishes quality control verification and phasing-in requirements for the first and subsequent batches of pharmaceutical products and medical devices prior to marketing or distribution in the Peruvian market. ; ;

Products Covered: ;- Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products. ;- Medical devices ;These products are classified under Chapter 30 of the Harmonized System or Customs Tariff. ;

Regulation Type: Regular notification

Human health

DKS 2583 2014 - Denatonium Benzoate in Alcohol - Test Method (6 pages, in English)

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Distribution date: 17 November 2014 | Final date for Comment: 28 November 2014

<span ><span >Gives test method for Denatonium Benzoate in alcohol</span></span>

Products Covered: Cyclic amides, incl. cyclic carbamates, and their derivatives; salts thereof (excl. ureines and their derivatives, salts thereof, 2-acetamidobenzoic acid "N-acetylanthranilic acid" and its salts and ethinamate "INN") (HS code(s): 292429); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Human health

DKS 2583 2014 - Denatonium Benzoate in Alcohol - Test Method (6 pages, in English)

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Distribution date: 17 November 2014 | Final date for Comment: 28 November 2014

<span ><span >Gives test method for Denatonium Benzoate in alcohol</span></span>

Products Covered: Cyclic amides, incl. cyclic carbamates, and their derivatives; salts thereof (excl. ureines and their derivatives, salts thereof, 2-acetamidobenzoic acid "N-acetylanthranilic acid" and its salts and ethinamate "INN") (HS code(s): 292429); Products of the chemical industry (ICS code(s): 71.100)

Regulation Type: Regular notification

Human health

Draft Decree of Minister of Industry on Mandatory Implementation of Indonesian National Standard for Glass in Building – Glass Blocks – Specification and Test Methods (SNI and Technical Specification: SNI ISO 21690:2013) (14 pages, in Indonesian)

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Distribution date: 14 November 2014 | Final date for Comment: 13 January 2015

<p >&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; This draft of decree states that all of <span lang="IN" >Glass in Building</span><span lang="IN"> </span>produced within the country or imported, distributed and marketed in the country shall fulfill the SNI<span> </span>requirements. <span ><ins cite="mailto:Esti" dateTime="2010-09-22T14:21">The producers which produced these products therefore shall comply with th</ins></span><span lang="IN" >ose<ins cite="mailto:Esti" dateTime="2010-09-22T14:21"> requirements proven by having Product Certificate for Using SNI Mark</ins>.</span><span lang="IN" ><span></span></span></p><p >&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The product certificate on SNI marking shall be issued by a Product Certification Body which has been <ins cite="mailto:Esti" dateTime="2011-01-26T16:24">accredited by KAN and </ins>appointed by the Minister of Industry th<ins cite="mailto:Esti" dateTime="2011-01-26T16:26">r</ins>ough testing of the conformity of the products quality against SNI requirements. </p><p >&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Directorate General of Manufacturing Based Industries, Ministry of Industry is the institution that is responsible for the implementation of this decree and shall provide a <span><del cite="mailto:Esti" dateTime="2010-08-20T13:59"></del></span><span><ins cite="mailto:Esti" dateTime="2010-08-20T13:59"></ins></span>technical guidance of the decree, which cover procedure of Product Certification and SNI Marking. Products which are distributed in domestic market that originated domestically and imported shall meet the requirements <span><del cite="mailto:Esti" dateTime="2010-08-20T14:05"></del></span>consist<ins cite="mailto:Esti" dateTime="2010-08-20T14:05"><span >ed</span></ins> in <span lang="IN"></span><span lang="FI" >SNI ISO 21690:2013 which specifies </span>term and definition, quality requirements, sampling, testing method, testing acceptance, marking requirement<span>&nbsp; </span>and packaging.<span lang="IN" ><br /></span></p><p ><span><ins cite="mailto:Esti" dateTime="2010-08-20T14:00"><br type="_moz" /></ins></span><span></span></p>

Products Covered: Product: Glass in Building – Glass Blocks – Specification and Test Methods (HS Number : 7016.10.00.00 and 7016.90.00.00) ;

Regulation Type: Regular notification

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