Draft resolution number 663, 24 June 2019, regarding the active ingredient C58 - ALFA-CIPERMETRINA of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 02 July 2019 | Final date for Comment: 26 August 2019

This Draft resolution incorporates the following changes for the active ingredient C58 - ALFA-CIPERMETRINA 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 sweet potatoes, yacon, greater yam, yam and radish cultures with MRL of 0.02 mg/kg and safety securityu period of 14 days;- includes shallot culture with MRL of 0.05 mg/kg and safety security period of 7 days;- includes raspberry, cranberry and purple mumbim cultures with MRL of 1.0 mg/kg and safety security period of 7 days;- includes cupuacu, kiwifruit and pomegranate cultures with MRL of 0.7 mg/kg and safety security period of 7 days;- includes cassava culture with MRL of 0.05 mg/kg and safety security period of 14 days;- includes gherkin culture with MRL of 0.05 mg/kg and safety security period of 7 days;- includes stevia culture with MRL of 0.07 mg/kg and and safety security period of 7 days;- includes melon culture with MRL of 0.02 mg/kg and safety security period of 10 days;- includes palnts for ornamental purposes: crysanthemun and roses cultures with MRL and safety security period  of non-food use.

Products Covered: HS Code(s): 071420, 0706, 070310, 081020, 081040, 081050, 071410, 0707, 08071, 0603, 0604, 071430, 17029040000, 08109010, 10119029, cupuacu; ICS Code(s): 13, 65

Regulation Type: Regular notification

Maximum residue limits (MRLs) Human health Pesticides Food safety

Draft resolution number 661, 24 June 2019, regarding the active ingredient T33 - TEFLUBENZUROM of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, published by Resolution - RE n° 165 of 29 August 2003, on the Brazilian Official Gazette (DOU - Diário Oficial da União) of 2 September 2003

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Distribution date: 02 July 2019 | Final date for Comment: 26 August 2019

This Draft resolution incorporates the following changes the active ingredient T33 - TEFLUBENZUROM of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar use(application):- includes kiwifruit and pomegranate cultures with MRL of 0.7 mg/kg and safety security period of 7days;- includes raspberry, cranberry and purple mumbim cultures with MRL of 1.0 mg/kg and safety security period of 7 days;- includes carrot, sweet potatoes, yacon, greater yam, yams, cassava and radish cultures with MRL 0.05 mg/kg and safety security period of 14 days;- includes shallot culture with MRL of 0.03 mg/kg and safety security period of 7 days;- includes witloof chicory and stevia cultures with MRL of 0.3 mg/kg and safety security period of 7 days;- includes gherkin culture with MRL of 0.01 mg/kg and safety security period of 7 days;- includes guarana culture with with MRL of 0.2 mg/kg and safety security period of 7 days;- includes nectarine culture with MRL of 0.2 mg/kg and safety security period of 15 days;- includes linseed culture with MRL of 2.0 mg/kg and safety security period of 7 days;- includes plants for ornamental purposes: alstroemeria, alyssum, amaryllis, azalea, snapdragon, purple arrowroot, cockscomb, coleus, carnation, crysanthemun, euonymus, ruscus, gardenia, geranium, gerbera, gladiolus, hydrangea, lantana, lily, lisianthus, daisy, roses, garden sage, Sedum makinoi, vervain, vincan and zinnia cultures with MRL and safe security period for non-food use;- changes MRL of cupuacu culture from 0.2 to 0.7 mg/kg.

Products Covered: HS Code(s): 081050, 081020, 081040, 0706, 071420, 071410, 0703, 070521, 071140, 200870, 1204, 0603, 0604, 0602, 08109010, 07143, 17029040000, 10119029, 13021990, cupuacu; ICS Code(s): 13, 65

Regulation Type: Regular notification

Food safety Human health Pesticides Maximum residue limits (MRLs)

Draft resolution (Consulta Pública) 657, 24 June 2019 (4 pages, Portuguese). Comment form: http://formsus.datasus.gov.br/site/formulario.php?id_aplicacao=48148

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Distribution date: 02 July 2019 | Final date for Comment: 16 August 2019

This draft resolution establishes criteria and deadlines for market authorization and notification of medicines, and provides other measures.

Products Covered: HS CODE: 30

Regulation Type: Regular notification

Human health

Control of Drugs and Cosmetics Regulations 1984: Senior Director of Pharmaceutical Services Directive (Series No.10, 2019): Directive to Limit the Usage of Colistin in Veterinary Medicines

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Distribution date: 02 July 2019 | Final date for Comment: 31 August 2019

The Directive is addressed to all product registration holder to limit the usage of colistin in veterinary medicines in which the usage of colistin is not allowed in veterinary medicines indicated for food-producing animals in the form of preparation to be added into the feed and water (for example premix, water soluble powder and solution). Registered product: Cancellation of registered product starting from 1st January 2020 New application and products under evaluation status: Rejection of product registration application starting from the date of issuance of the Directive Renewal of product registration application: Allowed until 1st January 2020 The Directive is not applicable for veterinary medicines containing colistin indicated for non-food producing animals.

Products Covered: Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of two or more constituents which have been mixed together for therapeutic or prophylactic uses, not put up in measured doses or in forms or packings for retail sale. Other, containing antibiotics: Veterinary medicaments HS: 3003.20.0010 Medicaments (excluding goods of heading 30.02, 30.05 or 30.06) consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses (including those in the form of transdermal administration systems) or in forms or packings for retail sale. Other, containing antibiotics: Other: Of a kind taken orally or in ointment form: Veterinary medicaments HS: 3004.20.9110

Regulation Type: Regular notification

Draft normative instruction (Consulta Publica) number 659, 24 June 2019, regarding maximum residue limit (MRL) of veterinary drugs in food of animal orign. Published on D.O.U., 26 June 2019

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Distribution date: 03 July 2019 | Final date for Comment: 02 September 2019

This draft resolution establishes the MRL for veterinary drugs in food of animal origin.

Products Covered: HS Code(s): 30049085 (Veterinary medicinal preparations, not for human use, not elsewhere specified or included); ICS Code(s): 13, 65

Regulation Type: Regular notification

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

Draft resolution (Consulta Publica) number 658, 24 June 2019, regarding maximum residue limit (MRL) of veterinary drugs in food of animal orign. Published on D.O.U., 26 June 2019

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Distribution date: 03 July 2019 | Final date for Comment: 02 September 2019

This draft resolution establishes the procedure for risk assessment of veterinary drugs to human health and the methods for conformity assessment procedures.

Products Covered: HS Code(s): 30049085 (Veterinary medicinal preparations, not for human use, not elsewhere specified or included); ICS Code(s): 13, 65

Regulation Type: Regular notification

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

DUS DEAS 981:2019, Hydraulic road binders ― Composition, specifications and conformity criteria, First Edition.

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Distribution date: 08 July 2019 | Final date for Comment: 06 September 2019

This Draft Uganda Standard applies to hydraulic road binders produced in a factory and supplied ready for use in road bases, sub-bases, capping layers, and soil stabilization or soil improvement. It specifies the mechanical, physical and chemical requirements for hydraulic road binders, together with the conformity criteria and evaluation procedures to be applied by the manufacturer. The stabilized road bases, sub-bases, capping layers, and soil stabilization or soil improvement by application of this hydraulic road binder shall comply with the requirements of BS 1924-1 Stabilized materials for civil engineering purposes ― Part 1: General requirements, sampling, sample preparation and tests on materials before stabilization and BS 1924 -2 Stabilized materials for civil engineering purposes ― Part 2: Methods of tests for cement-stabilized and lime–stabilized materials.

Products Covered: Hydraulic road binders

Regulation Type: Regular notification

Partial revision of the Japanese Pharmacopoeia, Seventeenth edition (JP17-2, final rule) Revision to establish, amend and delete articles under Japanese Pharmacopoeia, Seventeenth edition notified in G/TBT/N/JPN/622 (dated 18 March 2019) was adopted and published on 28 June 2019. The outline of revision are available as attached file.  

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Distribution date: 08 July 2019 | Final date for Comment: 03 May 2025

Products Covered: Pharmaceutical Products (HS:30)

Regulation Type: Addendum to Regular Notification

Notice of Modification to the List of Permitted Food Enzymes to Enable the Use of Lipase from Trichoderma reesei Morph Lip3 in Bread, Flour, Whole Wheat Flour, Unstandardized Bakery Products, and Pasta - Reference Number: NOM/ADM-0134

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Distribution date: 09 July 2019 | Final date for Comment: 10 September 2019

Health Canada's Food Directorate completed a premarket safety assessment of a food additive submission seeking approval for the use of lipase from Trichoderma reesei Morph Lip3 in bread, flour, whole wheat flour, unstandardized bakery products, and pasta. Lipase from other source organisms is already permitted for use in Canada as a food enzyme in a number of foods including those of interest to the petitioner. The results of the premarket assessment support the safety and efficacy of lipase from T. reesei Morph Lip3 for its requested uses. Consequently, Health Canada has enabled the use of lipase from T. reesei Morph Lip3 described in the information document below by modifying the List of Permitted Food Enzymes (https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/food-additives/lists-permitted/5-enzymes.html), effective 27 June 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: Lipase from Trichoderma reesei Morph Lip3 (ICS Code: 67.060)

Regulation Type: Regular notification

Food safety Human health Food additives

Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards lead and its compounds (6 pages + Annex 4 pages, in English)

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Distribution date: 12 July 2019 | Final date for Comment: 10 September 2019

This draft Regulation would amend entry 63 to Annex XVII to Regulation (EC) No 1907/2006. It would prohibit the use of lead and lead compounds in articles produced from polymers or copolymers of vinyl chloride as well as their placing on the market in articles produced from PVC if the concentration of lead (expressed as metal) is equal to or greater than 0.1% by weight of the PVC material. Time-limited exemptions from this limit are provided for rigid and flexible recycled PVC material and for PVC-silica separators in lead acid batteries.

Products Covered: Articles made of polyvinyl chloride (PVC) containing lead and lead compounds.

Regulation Type: Regular notification

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