Regulatory Updates

Distribution date: 24 September 2019 | Final date for Comment: 08 November 2019

This draft resolution proposes the revision of the Resolution – RDC number 4, 4 February 2011, which establishes the minimum requirements of identity and quality for transfusion, infusion and transfusion pumps sets for single use. Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=50302

Products Covered: HS Code(s): 30045020 (infusion sets for single use)

Regulation Type: Regular notification

Distribution date: 23 September 2019 | Final date for Comment: 01 November 2019

The procedure for pattern or type approval of measuring instruments, as given in the Metrology Act Chapter 13.18,  has been amended.

Products Covered: Measuring instruments subject to pattern or type approval under Saint Lucia’s Metrology Act Chapter 13.18. 8413.11 Fuel dispensers 8413.91 Other 8423.20 Scales for continuous weighing of goods on conveyors 8423.30 Constant weight scales and scales for discharging a predetermined weight of material into a bag or container, including hopper scales 8423.81 Having a maximum weighing capacity not exceeding 30 kg 8423.82 Having a maximum weighing capacity exceeding 30 kg but not exceeding 5,000 kg 8423.89 Other 8423.90 Weighing machine weights of all kinds; parts of weighing machinery 9016.00 Balances of a sensitivity of 5 cg or better, with or without weights. 9017.80 Other instruments 9018.90 Blood pressure monitors 9024.80 Other machines and appliances 9025.11 Liquid-filled, for direct reading 9025.19 Other 9026.20 For measuring or checking pressure 9027.80 Breathalyzers 9028.10 Gas meters 9028.20 Water meters 9028.30 Electrical energy meters 9031.80 Other instruments

Regulation Type: Regular notification

Distribution date: 19 September 2019

This technical instruction stipulates the standards of micro-organism limits for proprietary Chinese medicines and traditional medicines. This Technical Instruction sets out the upper limits of heavy metals and toxic elements in traditional medicines.

Products Covered: Proprietary Chinese medicines; traditional medicines

Regulation Type: Regular notification

Distribution date: 17 September 2019 | Final date for Comment: 26 October 2019

This Draft resolution incorporates the following changes for the active ingredient C18 - CLOROTALONIL (chlorothalonil) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL of the cotton culture from 0.2 mg/kg to 2.0 mg/kg.

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

Regulation Type: Regular notification

Distribution date: 17 September 2019 | Final date for Comment: 26 October 2019

This Draft resolution incorporates the following changes for the active ingredient T24 - TRIFLURALINA (trifluralin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of pre-emergency use (application):- includes the barley culture with MRL of 0.03 mg/kg and safety security period not determined due to the modality of use (application).

Products Covered: HS Code(s): 1003; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 17 September 2019 | Final date for Comment: 26 October 2019

This Draft resolution incorporates the following changes for the active ingredient G01 - GLIFOSATO (glyphosate) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of post-emergency use (application):- includes the persimon, guava, fig, star fruit and mangaba cultures with MRL of 0.2 mg/kg and safety security period of 17 days;- includes the cassava, sweet potato, beetroot, purple yam, carrot, ginger, yams, arracacha, turnip, yacon and radish cultures with MRL of 0.01 mg/kg and safety security period of 90 days;- includes the groundnut, peas, chickpea, lentil and caupi bean cultures with MRL of 0.01 mg/kg and safety security period not determined due to the modality of use (application).

Products Covered: HS Code(s): 0706, 070610, 071320, 071410, 071420, 080420, 080450, 091010, 070810, 071340, 08107000, 081090, 07143000, 0714900011, 17029040000, 20081920, 07133500, mangaba; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 17 September 2019 | Final date for Comment: 26 October 2019

This Draft resolution incorporates the following changes for the active ingredient L05 - LUFENURON (lufenuron) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use (application):- changes the MRL of the peach culture from 0.03 to 0.2 mg/kg and mantains the safety security period of 10 days.

Products Covered: HS Code(s): 080930; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 17 September 2019 | Final date for Comment: 26 October 2019

This Draft resolution incorporates the following changes for the active ingredient T16 - TIRAM (thiram) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of soil use (application):- includes the cane sugar culture with MRL of 0.1 mg/kg and safety security period not determined due to the modality of use (application).

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

Regulation Type: Regular notification

Distribution date: 17 September 2019 | Final date for Comment: 26 October 2019

This Draft resolution incorporates the following changes for the active ingredient C05 - CARBOXINA (carboxin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of soil use (application):- includes the cane sugar culture with MRL of 0.01 mg/kg and safety security period not determined due to the modality of use (application).

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

Regulation Type: Regular notification

Distribution date: 17 September 2019 | Final date for Comment: 26 October 2019

This Draft resolution incorporates the following changes for the active ingredient G05 - GLUFOSINATO (glufosinate) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of post-emergency use (application): - include the acai, Brazil nuts, coconut, palm nuts, macadamia nuts, pecan nuts, pine nuts and peach palm cultures with MRL of 0.05 mg/kg and safety security period of 40 days;- includes the oat, rye, barley and trticale cultures with MRL of 0.5 mg/kg and safety securiy period "not determined due to the modality of use (application);- includes the duboisia culture with MRL and safety security period of "Non-food use";- changes the phrase at item "i": "for the purpose of residue definition for conformity with MRL and for the dietary risk assessment it will be considered the sum of the active ingridientglufosinato-amônio, acid 3-(hidroximetilfosfonoil) propiônico and N-acetil-glufosinato, expressed as glufosinate".

Products Covered: HS Code(s): 08012, 08011, 120710, 1004, 1003, 1002, 20079921, 08026000, 08029010, 08029000, 0810909050, triticale, duboisia; ICS Code(s): 13, 65

Regulation Type: Regular notification