Regulatory Updates

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

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

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

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

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

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

This Draft resolution incorporates the following changes for the active ingredient F69 – FLUPIRADIFURONE from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality and of foliar use (application): - includes the oats, rye, barley, wheat and triticale cultures with MRL of 4.0 mg/kg and safety security period of 75 days;- changes the phrase at item "j": "for the purpose of residue definition for conformity with MRL it will be considered the active ingridient flupiradifurone, and for the dietary risk assessment: flupiradifurone and its metabolite BYI 02960-acid, expressed as flupiradifurone".

Products Covered: HS Code(s): 1004, 1002, 1003, 1001, triticale; ICS Code(s): 13, 65

Regulation Type: Regular notification

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

This Draft resolution incorporates the following changes the active ingredient Q05.1 - QUIZALOFOPE-P-ETÍLICO of the Monograph List of Active Ingredients for Pesticides, Household Cleaning Products and Wood Preservers all in the modality of post-emergency use (application): - the rice culture with MRL of 0.3 mg/kg and safety security period of 45 days.

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

Regulation Type: Regular notification

Distribution date: 21 June 2019 | Final date for Comment: 31 July 2019

Imported gelatin and its derivatives, other glues of animal origin, for food purpose shall be accompanied by official certificates issued by the competent authority of the exporting country. The requirements are as follows: 1. The import of gelatin and its derivatives, other glues of animal origin, for food purpose shall be accompanied by official certificates issued by the competent authority of the exporting country indicating that the attested products are suitable "for human consumption", or "in compliance with relevant food safety and sanitary regulations";2. Following the above measure, the certificate for gelatin and its derivatives, other glues of animal origin shall also attest information on the parts/tissues of raw materials used (ex: skin, bone or fish scales);3. The requirements apply to products of HS Codes are 3503.00.10.00-4 "Gelatin", 3503.00.20.00-2 "Gelatin derivatives" and 3503.00.90.90-8 "Other glues of animal origin, excluding casein glues of heading No. 35.01".

Products Covered: Gelatin and its derivatives, other glues of animal origin, for food purpose under HS Codes 3503.00.10.00-4, 3503.00.20.00-2 and 3503.00.90.90-8

Regulation Type: Revision to Regular Notification

Distribution date: 19 June 2019

The National Animal Health Service (SENASA) requires that establishments engaged in the storage, marketing, transportation, distribution and use of veterinary drugs and related products comply with the CAMEVET guide to good practices for the storage, transportation and distribution of products for veterinary use. Text available at: https://members.wto.org/crnattachments/2019/SPS/CRI/19_3496_00_s.pdf

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 19 June 2019 | Final date for Comment: 27 August 2019

Health Canada has conducted a scientific assessment which supports the establishment of maximum levels (MLs) for inorganic arsenic in polished (white) and husked (brown) rice. These MLs would also apply to these types of rice when used as ingredients in other foods. The Government is also collecting more data on rice-based foods, including products for infants and young children. This will inform the Department's future consideration of whether additional MLs for such foods are required. If it is determined that additional MLs for other rice-based foods are warranted, then Health Canada will announce its intention to establish these MLs via a separate notice. The purpose of this communication is to publically announce the Department's intention in this regard and to provide the appropriate contact information for any inquiries or feedback on the new maximum levels for inorganic arsenic in rice and the proposed next steps for other rice-based foods.

Products Covered: Maximum levels for inorganic arsenic in polished (white) and husked (brown) rice (ICS Code: 67.060)

Regulation Type: Regular notification