Regulatory Updates

Distribution date: 16 December 2019 | Final date for Comment: 14 February 2020

  Este reglamento técnico ecuatoriano establece los requisitos que deben cumplir los envases metálicos, previamente a la comercialización de productos nacionales e importados, con el propósito de proteger la seguridad y la salud de las personas; así como prevenir prácticas que puedan inducir a error. Este reglamento técnico se aplica a los productos: Envases metálicos (latas) de calibre ligero, de sellado hermético, para productos alimenticios procesados y bebidas no carbonatadas, con un máximo de espesor nominal del material de 0,49 mm, Envases metálicos. Tubos colapsibles de aluminio para productos farmacéuticos y cosméticos no alcalinos. Este reglamento técnico no aplica a: Envases metálicos industriales destinados a productos químicos u orgánicos con base agua o solvente tales como pinturas, disolventes y productos químicos en general.

Products Covered: - Of a capacity of less than 50 litres: (HS code(s): 73102); Cans of iron or steel, of a capacity of < 50 l, which are to be closed by soldering or crimping (excl. containers for compressed or liquefied gas) (HS code(s): 731021); Tanks, casks, drums, cans, boxes and similar containers, of iron or steel, for any material, of a capacity of < 50 l, n.e.s. (excl. containers for compressed or liquefied gas, or containers fitted with mechanical or thermal equipment, and cans which are to be closed by soldering or crimping) (HS code(s): 731029); Casks, drums, cans, boxes and similar containers, incl. rigid or collapsible tubular containers, of aluminium, for any material (other than compressed or liquefied gas), of a capacity of

Regulation Type: Revision to Regular Notification

Distribution date: 16 December 2019

Products Covered: Pharmaceutical products (HS 30); perfumes and toilet waters (HS 3303); beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or suntan preparations; manicure or pedicure preparations (HS 3304); preparations for use on the hair (HS 3305); soap; organic surface-active products and preparations for use as soap, in the form of bars, cakes, moulded pieces or shapes, whether or not containing soap; organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not containing soap; paper, wadding, felt and nonwovens, impregnated, coated or covered with soap or detergent (HS 3401); organic surface-active agents (other than soap); surface-active preparations, washing preparations (including auxiliary washing preparations) and cleaning preparations, whether or not containing soap, other than those of heading 34.01 (HS 3402); -- of a kind used in the textile or like industries (HS 380991); toilet paper and similar paper, cellulose wadding or webs of cellulose fibres, of a kind used for household or sanitary purposes, in rolls of a width not exceeding 36 cm, or cut to size or shape; handkerchiefs, cleansing tissues, towels, tablecloths, serviettes, napkins and napkin liners for babies, sanitary towels (pads) and tampons, bed sheets and similar household, sanitary or hospital articles, articles of apparel and clothing accessories (HS 4818); wadding of textile materials and articles thereof; textile fibres, not exceeding 5 mm in length (flock), textile dust and mill neps (HS 5601); instruments and appliances used in medical, surgical, dental or veterinary sciences, including scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments (HS 9018); mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus (HS 9019); orthopaedic appliances, including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of the body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate for a defect or disability (HS 9021); apparatus based on the use of X-rays or of alpha, beta or gamma radiations, whether or not for medical, surgical, dental or veterinary uses, including radiography or radiotherapy apparatus, X-ray tubes and other X-ray generators, high tension generators, control panels and desks, screens, examination or treatment tables, chairs and the like (HS 9022); medical, surgical, dental or veterinary furniture (for example, operating tables, examination tables, hospital beds with mechanical fittings, dentists' chairs); barbers' chairs and similar chairs, having rotating as well as both reclining and elevating movements; parts of the foregoing articles (HS 9402). ;Pharmaceutical products: medicine, herbal medicine, dietary products and sweeteners, and biological and galenic products classified under Chapter 30 of the Harmonized System or Customs Tariff. ;Medical devices classified under headings 9018, 9019, 9021, 9022 and 9402 of the Harmonized System or Customs Tariff. ;Sanitary products: cosmetics, domestic hygiene products and absorbent personal hygiene products classified under the following headings of the Harmonized System or Customs Tariff: 3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601. ;

Regulation Type: Addendum to Regular Notification

Distribution date: 16 December 2019 | Final date for Comment: 11 January 2020

This draft resolution incorporates the following changes for the active ingredient M02 - MANCOZEBE (mancozeb) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modalites of plantation furrows use (application):-includes the cane sugar culture with MRL of 0,07 mg/kg and safety security period "Not-determined due to the modality of use".

Products Covered: HS Code(s): 170111; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 13 December 2019 | Final date for Comment: 21 December 2019

This Draft resolution incorporates the following changes for the active ingredient M02 - MANCOZEBE (mancozeb) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:-includes the cane sugar culture with MRL of 0,07 mg/kg and safety security period "not determined due to the modality of furrows use (application)";-includes the sorghum culture with MRL of 0,4 mg/kg and safety security period of 30 days in the modality of foliar use (application);-includes the oat culture with MRL of 1,0 mg/kg and safety security period of 32 days in the modality of foliar use (application);-changes the MRL of the rice culture from 0,5 to 0,8 mg/kg in the modality of foliar use (application);-changes the MRL of the corn and sorghum cultures from 0,3 to 0,4 mg/kg in the modality of foliar use (application).

Products Covered: HS Code(s): 170111, 1007, 1004, 1006, 1005; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 13 December 2019 | Final date for Comment: 21 December 2019

This Draft resolution incorporates the following changes for the active ingredient A04 - ÁCIDO GIBERÉLICO (gibberellic acid) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):-includes the pineapple and persimmon cultures MRL and safety security period is "not determined".

Products Covered: HS Code(s): 080430, 08107000, ; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 13 December 2019 | Final date for Comment: 21 December 2019

This Draft resolution incorporates the following changes for the active ingredient C36 - CIPROCONAZOL (cyproconazole) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):-includes the sorghum culture with MRL of 0,01 mg/kg and safety security period of 15 days;-changes the MRL of the cotton culture from 0,05 to 0,1 mg/kg;-changes the MRL of the rice culture from 0,4 to 1,0 mg/kg.

Products Covered: HS Code(s): 100700, 52, 1006; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 13 December 2019

This resolution establishes the sanitary technical requirements for desalinated, potable, and bottled seawater. This regulation will be also notified to the TBT committee.

Products Covered: HS Code(s): 84133090 (desalinated sea water); ICS Code(s): 13

Regulation Type: Regular notification

Distribution date: 11 December 2019

Health Canada's Food Directorate completed a premarket safety assessment of a food additive submission seeking approval for the use of Xylanase from Trichoderma reesei (LOVxlnA#568.4) in Bread, Flour, Whole Wheat Flour and Unstandardized Bakery Products. The results of the Food Directorate's evaluation of available scientific data support the safety of xylanase from T. reesei (LOVxlnA#568.4) when used as requested by the petitioner.  Therefore, Health Canada has modified the List of Permitted Food Enzymes, effective 21 November 2019. The purpose of this communication is to publically announce the Department's decision in this regard and to provide the appropriate contact information for any inquiries or for those wishing to submit any new scientific information relevant to the safety of this food additive.

Products Covered: Xylanase from Trichoderma reesei (LOVxlnA#568.4)  (ICS Codes: 67.060, 67.220.20)

Regulation Type: Regular notification

Distribution date: 09 December 2019 | Final date for Comment: 26 January 2019

The notified regulation opens a 60-day period for public consultation on the draft of a technical regulation establishing the identity and minimum quality requirements that must meet gelatin, fish gelatin and hydrolyzed gelatin, collagen, skin, shavings and scrapes for gelatin and collagen production.

Products Covered: 3503.00 - gelatin

Regulation Type: Regular notification

Distribution date: 06 December 2019 | Final date for Comment: 04 February 2020

The overall regulation and control of importation, distribution and use of veterinary drugs and medicinal substances. The regulations shall protect animals from substandard veterinary medicinal products and humans from veterinary drugs residues in food of animal origin.

Products Covered: Veterinary drugs and medicinal substances

Regulation Type: Regular notification