Regulatory Updates

Proyecto de Segunda Revisión del Reglamento Técnico Ecuatoriano PRTE INEN 061 (2R) "Pinturas" (Draft second revision (2R) of Ecuadorian Technical Regulation PRTE INEN No. 061 "Paints") (23 pages, in Spanish)

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Distribution date: 28 October 2019 | Final date for Comment: 27 November 2019

The notified Ecuadorian Technical Regulation establishes the requirements to be met by paints, prior to the marketing of domestic and imported products, with the aim of protecting human health and safety and preventing deceptive practices. It applies to the following products: 1. Anti-corrosion paint. Alkyd gloss enamel; 2. Architectural paints. Water-based emulsion paints (latex); 3. Paints. Synthetic alkyd enamel for household use; 4. Paints. Synthetic alkyd enamel for vehicles; 5. Paints. Nitrocellulose base coats for repainting in the motor vehicle industry; 6. Paints. Anti-corrosion alkyd vehicle primers; 7. Paints. Anti-corrosion epoxy vehicle primers; 8. Paints. Acrylic lacquers for repainting vehicles; 9. Paints. Acid-catalysed clear or matt lacquers for wood finishing; 10. Paints. Nitrocellulose lacquers for wood finishing; 11. Paints. Nitrocellulose lacquers for repainting vehicles; 12. Paints. Nitrocellulose and polyester fillers; 13. Paints. Anti-corrosion coatings for high temperatures; 14. Paints. Sandable nitrocellulose sealant for wood; 15. Paints for traffic signs; 16. Paints for use by children and in schools.

Products Covered: Paints and varnishes, incl. enamels and lacquers, based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous medium; solutions of products of subheading 3901 to 3913 in volatile organic solvents, containing > 50% solvent by weight (excl. solutions of collodion) (HS code(s): 3208); Paints and varnishes, incl. enamels and lacquers, based on polyesters, dispersed or dissolved in a non-aqueous medium; solutions based on polyesters in volatile organic solvents, containing > 50% solvent by weight (HS code(s): 320810); Paints and varnishes, incl. enamels and lacquers, based on acrylic or vinyl polymers, dispersed or dissolved in a non-aqueous medium; solutions based on acrylic or vinyl polymers in volatile organic solvents, containing > 50% solvent by weight (HS code(s): 320820); Paints and varnishes based, incl. enamels and lacquers, on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in a non-aqueous medium, and solutions of products of subheading 3901 to 3913 in volatile organic solvents, containing > 50% solvent by weight (excl. those based on polyesters and acrylic or vinyl polymers and solutions of collodion) (HS code(s): 320890); Paints and varnishes, incl. enamels and lacquers, based on synthetic polymers or chemically modified natural polymers, dispersed or dissolved in an aqueous medium (HS code(s): 3209); Paints and varnishes, incl. enamels and lacquers, based on acrylic or vinyl polymers, dispersed or dissolved in an aqueous medium (HS code(s): 320910); Paints and varnishes, incl. enamels and lacquers, based on synthetic or chemically modified natural polymers, dispersed or dissolved in an aqueous medium (excl. those based on acrylic or vinyl polymers) (HS code(s): 320990); Paints and varnishes, incl. enamels, lacquers and distempers (excl. those based on synthetic polymers or chemically modified natural polymers); prepared water pigments of a kind used for finishing leather (HS code(s): 3210); Paints and varnishes, incl. enamels, lacquers and distempers (excl. those based on synthetic polymers or chemically modified natural polymers); prepared water pigments of a kind used for finishing leather (HS code(s): 321000); Pigments, incl. metallic powders and flakes, dispersed in non-aqueous media, in liquid or paste form, of a kind used in the manufacture of paints; colorants and other colouring matter, n.e.s. put up for retail sale (HS code(s): 321290); Sets of artist's, student's or signboard painter's colours, modifying tints, amusement colours and the like, in tablets, tubes, jars, bottles, pans or similar packages (HS code(s): 321310); Glaziers' putty, grafting putty, resin cements, caulking compounds and other mastics; painters' fillings (HS code(s): 321410); Saturated polyesters in primary forms (excl. polycarbonates, alkyd resins and poly"ethylene terephthalate") (HS code(s): 390799); Paints and varnishes (ICS code(s): 87.040)

Regulation Type: Revision to Regular Notification

Proyecto de Tercera Revisión del RTE INEN 033 (3R) "Baldosas Cerámicas" (Draft third revision (3R) of RTE INEN No. 033 "Ceramic tiles") (14 pages, in Spanish)

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Distribution date: 28 October 2019 | Final date for Comment: 27 November 2019

The notified Ecuadorian Technical Regulation establishes the requirements to be met by ceramic tiles, prior to the marketing of domestic and imported products, with the aim of preventing deceptive practices. It applies to the following products: Ceramic tiles listed in annexes A to M of ISO 13006: Annex: Type of tile Annex A Extruded ceramic tiles - Group AIb, 0.5% < Ev ≤ 3% Annex B Extruded ceramic tiles - Group AIIa-1, 3% < Ev ≤ 6% Annex C Extruded ceramic tiles - Group AIIa-2, 3% < Ev ≤ 6% Annex D Extruded ceramic tiles - Group AIIb-1, 6% < Ev ≤ 10% Annex E Extruded ceramic tiles - Group AIIb-2, 6% < Ev ≤ 10% Annex F Extruded ceramic tiles - Group AIII, Ev > 10% Annex G Dry-pressed ceramic tiles - Group BIa, Ev ≤ 0.5% Annex H Dry-pressed ceramic tiles - Group BIb, 0.5% < Ev ≤ 3% Annex J Dry-pressed ceramic tiles - Group BIIa, 3% < Ev ≤ 6% Annex K Dry-pressed ceramic tiles - Group BIIb, 6% < Ev ≤ 10% Annex L Dry-pressed ceramic tiles - Group BIII, Ev > 10% Annex M Extruded ceramic tiles - Group AIa, Ev ≤ 0.5% It does not apply to: Ceramic tiles manufactured using a process other than the normal extrusion or dry-pressing process. It does not apply to decorative accessories or trims such as borders, corners, skirting boards, cornices, ceramic beads, stairs, curved tiles and other accessory pieces or mosaics (that is, any piece that can fit into an area of 49 cm2).

Products Covered: 6907.21.00 -- Of a water absorption coefficient by weight not exceeding 0.5%; 6907.22.00 -- Of a water absorption coefficient by weight exceeding 0.5% but not exceeding 10%; 6907.23.00 -- Of a water absorption coefficient by weight exceeding 10%; Refractory bricks, blocks, tiles and similar refractory ceramic constructional goods, other than those of siliceous fossil meals or similar siliceous earths (HS 6902); Ceramic tiles (ICS 91.100.23)

Regulation Type: Revision to Regular Notification

Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-KS-7/25511 as of 26 September 2019

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Distribution date: 28 October 2019

This letter introduces a temporary restriction on import of live swine, meat of swine and products containing pork, embryos of swine and boar semen from the Republic of Korea due to the registration of outbreaks of ASF.

Products Covered: Live swine, meat of swine, meat and edible meat offal, swine embryos and boar' semen (HS Codes: 0103; 0203; 0511; 020630000; 020910; 4103300000; 0210; 0502; 0511, 9601; 9705 00 000 0; 3101; 2309*; 160100*; 1602*)* with exception of prepared heat-treated goods of pork, prepared goods containing pork or raw materials of animal origin (from pork) for the production of feeds for non-productive and fur-producing animals with the use of technologies providing destruction of ASF in accordance with the provision of Chapter 15.1 of the OIE Terrestrial Animal Health Code.

Regulation Type: Emergency notifications (SPS)

Animal diseases Food safety African swine fever (ASF) Zoonoses Animal health Human health

Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-KS-7/28112 as of 24 October 2019

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Distribution date: 28 October 2019

This letter introduces a temporary restriction on import of live swine, meat of swine and products containing pork, embryos of swine and boar semen from Côte d'Ivoire due to the registration of outbreaks of ASF.

Products Covered: Live swine, meat of swine, meat and edible meat offal, swine embryos and boar' semen (HS Codes: 0103; 0203; 0511; 020630000; 020910; 4103300000; 0210; 0502; 0511, 9601; 9705 00 000 0; 3101; 2309*; 160100*; 1602*)* with exception of prepared heat-treated goods of pork, prepared goods containing pork or raw materials of animal origin (from pork) for the production of feeds for non-productive and fur-producing animals with the use of technologies providing destruction of ASF in accordance with the provision of Chapter 15.1 of the OIE Terrestrial Animal Health Code.

Regulation Type: Emergency notifications (SPS)

Animal diseases Food safety Animal health Human health Zoonoses African swine fever (ASF)

Letter of the Federal Service for the Veterinary and Phytosanitary No. FS-KS-7/28193 as of 24 October 2019

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Distribution date: 28 October 2019

This letter introduces a temporary restriction on import of live swine, meat of swine and products containing pork, embryos of swine and boar semen from the Lao People's Democratic Republic due to the registration of outbreaks of ASF.

Products Covered: Live swine, meat of swine, meat and edible meat offal, swine embryos and boar' semen (HS Codes: 0103; 0203; 0511; 020630000; 020910; 4103300000; 0210; 0502; 0511, 9601; 9705 00 000 0; 3101; 2309*; 160100*; 1602*)* with exception of prepared heat-treated goods of pork, prepared goods containing pork or raw materials of animal origin (from pork) for the production of feeds for non-productive and fur-producing animals with the use of technologies providing destruction of ASF in accordance with the provision of Chapter 15.1 of the OIE Terrestrial Animal Health Code.

Regulation Type: Emergency notifications (SPS)

Zoonoses African swine fever (ASF) Animal diseases Food safety Animal health Human health

The final date for comments (20 November 2019) of the Draft Resolution number 682, 12 August 2019 – previously notified through G/TBT/N/BRA/905 - which proposes the establishment of the Dossier for Active Pharmaceutical Ingredient (API) and of the Adequacy Charter of the Dossier for Active Pharmaceutical Ingredient, was extended for 30 days. The full text is available only in Portuguese and can be downloaded at:

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Distribution date: 28 October 2019

Products Covered: HS CODE: 29; 30. (active pharmaceutical ingredients)

Regulation Type: Addendum to Regular Notification

The final date for comments (20 November 2019) of Draft Resolution number 683, 12 August 2019 – previously notified through G/TBT/N/BRA/904 - which proposes the changing of the Resolution – RDC number 200, 26 December 2017, and of the RDC number 73, 7 April 2016, for the submission of the Dossier for Active Pharmaceutical Ingredient (API) in the market authorization and post-market authorization of medicines, respectively, was extended for 30 days. The full text is available only in Portuguese and can be downloaded at:

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Distribution date: 28 October 2019

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Regulation Type: Addendum to Regular Notification

The final date for comments (20 November 2019) of Draft Resolution number 688, 12 August 2019 – previously notified through G/TBT/N/BRA/900 - which establishes criteria for certification of Good Manufacturing Practice for international companies that manufacture Active Pharmaceutical Ingredients (API), was extended for 30 days. The full text is available only in Portuguese and can be downloaded at:

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Distribution date: 28 October 2019

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Regulation Type: Addendum to Regular Notification

The final date for comments (20 November 2019) of Draft Resolution number 689, 12 August 2019 – previously notified through G/TBT/N/BRA/899 - which establishes guidelines for authorization of suppliers related to the Technical Regulation for Good Practice of Distribution and Fractioning of Active Pharmaceutical Ingredients (API), was extended for 30 days. The full text is available only in Portuguese and can be downloaded at:

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Distribution date: 25 October 2019

Products Covered:

Regulation Type: Addendum to Regular Notification

Bathing bars – Specification This addendum aims to inform WTO Members that the draft Uganda standard; Bathing bars – Specification; notified in G/TBT/N/UGA/540 entered into force on 20 September 2019. The standard, US EAS 877:2017, Bathing bars – Specification, can be obtained online through the link https://webstore.unbs.go.ug/

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Distribution date: 24 October 2019

Products Covered: Bathing bars

Regulation Type: Addendum to Regular Notification

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