Regulatory Updates

Distribution date: 06 January 2020 | Final date for Comment: 06 March 2020

In order to strengthen the management of lot release of biological products, and ensure the quality and safety of biological products.

Products Covered: Human blood; animal blood prepared for therapeutic, prophylactic or diagnostic uses; antisera and other blood fractions and modified immunological products, whether or not obtained by means of biotechnological processes; vaccines, toxins, cultures of micro-organisms (excl. yeasts) and similar products (HS code(s): 3002); Medicaments consisting of two or more constituents mixed together for therapeutic or prophylactic uses, not in measured doses or put up for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3003); Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) (HS code(s): 3004); Medicaments (ICS code(s): 11.120.10)

Regulation Type: Regular notification

Distribution date: 06 January 2020 | Final date for Comment: 05 February 2020

Considering technical advancement and recent needs for fertilizers, the Ordinance for the Enforcement of the Fertilizer Regulation Act and other rules are revised as follows: 1. Lifting of the ban on fertilizer use of materials derived from sheep and goats As part of BSE-related feed ban, materials derived from sheep and goats have been prohibited to be used for producing fertilizers. Based on the result of the risk assessment conducted by the Food Safety Commission of Japan, materials derived from sheep and goats are permitted to be used for producing fertilizers under the appropriate condition for management of BSE specified in the administrative rules related to the Fertilizer Regulation Act. 2. Use of granular fertilizers made of fossil seashell and seashell for preparing compound fertilizers Fertilizer producers which notified MAFF of their product plan are permitted to use granular fertilizers made of fossil seashell or seashell to be used as materials for preparing compound fertilizers.  3. New testing manual for quantitative analysis of nutrient contents Guideline for qualitative analysis of nutrient contents for fertilizer registration shall be conducted by the testing manual edited by Food and Agricultural Materials Inspection Center. 4. Revision of the labeling rule concerning fertilizers derived from livestock There will be a change in the format of labels for fertilizers containing materials derived from livestock to indicate species of livestock which the materials are derived from. It is not required to attach a label to indicate that the process of the production of the fertilizers has been confirmed by the minister of Agriculture, Forestry and Fisheries.

Products Covered: Fertilizer (HS: 3101, 3102, 3103, 3104, 3105)

Regulation Type: Regular notification

Distribution date: 20 December 2019 | Final date for Comment: 18 February 2020

The MAFF will change the administrative rule of labeling for the fertilizers which contain materials derived from cattle, sheep and goats. 1. Background As part of the BSE-related feed ban, fertilizers which contain materials derived from cattle, sheep and goats must be produced with appropriate treatments in order to prevent BSE. However, there is a possibility that fertilizers or fertilizer materials produced without those treatments may be distributed or used by mistake. 2. New labeling rules When fertilizer producers trade fertilizers which contain materials derived from cattle, sheep and goats produced without appropriate treatments specified in the administrative rules, fertilizer producers shall attach a label indicating the prohibition of distribution to farmers or use for preparation of compound fertilizers.

Products Covered: Fertilizer (HS: 3101)

Regulation Type: Regular notification

Distribution date: 19 December 2019 | Final date for Comment: 02 October 2019

Period for comments extended by 30 days.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 19 December 2019 | Final date for Comment: 11 January 2020

This draft resolution incorporates the following changes for the active ingredient E04 - ENXOFRE (sulfur) 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, acai, barbados cherry, blackberry, soursop, oat, olive, cocoa beans, canola, persimon, star fruit, Brazil nuts, rye, barley, cupuacu, palm nuts, raspberry, sesamum seeds, sunflower, chickpea, guarana, jilo, kiwi, lentils, lychee, linseed, macadamia nuts, passion fruit, millet, bilberry, nectarine, loquat, ornamental, surinam cherry, peach palm, pomegranate, purple mumbim, sorghum and triticale cultures with MRL and safety security period "without restrictions" and ornamental cultures with MRL and safety security period of "Non-food use".

Products Covered: HS Code(s): 120740, 18, 200820, 081020, 1004, 08012, 100200, 1003, 120710, 1206, 071320, 071340, 1204, 100820, 0809, 1007, 071120, 080920, 081090, 08107000, 08026000, 08109090, 081049, 0810909002, 081190, 0810909050, 08109010, 071430, 08109060, triticale, guarana, jilo, cupuacu, acai, kiwi, canola; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 19 December 2019 | Final date for Comment: 11 January 2020

This draft resolution incorporates the following changes for the active ingredient F28 – FENPROPATRINA (fenpropathrin) 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 rice culture with MRL of 0,4 mg/kg and safety security period of 30 days;-includes the ground-nut culture with MRL of 0,01 mg/kg and safety security period of 14 days;-includes the pea culture with MRL of 0,01 mg/kg and safety security period of 14 days;-includes the caupi bean culture with MRL of 0,01 mg/kg and safety security period of 14 days.

Products Covered: HS Code(s): 1006, 200811, 070810, 07133500; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 19 December 2019 | Final date for Comment: 11 January 2020

This draft resolution includes the active ingredient A62 Amblyseius tamatavensis in the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers.

Products Covered: HS Code(s): 38089910; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 19 December 2019 | Final date for Comment: 11 January 2020

This draft resolution incorporates the following changes for the active ingredient B26 – BIFENTRINA (bifenthrin) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers, all in the modality of foliar and seed use (application):-changes the MRL of the soya culture from 0,02 to 0,04 mg/kg.

Products Covered: HS Code(s): 1201; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 19 December 2019 | Final date for Comment: 11 January 2020

This draft resolution incorporates the following changes for the active ingredient C55 - COMPOSTOS A BASE DE COBRE (copper hydroxide) 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, acai, barbados cherry, soursop, olive, sweet potato, yacon, greater yam, star fruit, Brazil nuts, shallot, cupuacu, chayote, raspberry, ginger, guarana, yams, kiwi, macadamia nuts, cassava, arracacha, mangaba, gherkin, bilberry, surinam cherry, peach palm, radish, pomegranate and purple mumbim cultures with MRL and safety security period "without restrictions" and the ornamental cultures with MRL and safety security period of "Non-food use".

Products Covered: HS Code(s): 070310, 071120, 071140, 071410, 071420, 08012, 080430, 081020, 081040, 091010, 0706, 080920, 081090, 17029040000, 071430, 13021990, 08026000, 0714900011, 081190, 0810909050, 08109010, cupuacu, acai, kiwi, mangaba ; ICS Code(s): 13, 65

Regulation Type: Regular notification

Distribution date: 19 December 2019 | Final date for Comment: 11 January 2020

This Draft resolution incorporates the following changes for the active ingredient A29 – ACETAMIPRIDO (acetamiprid) from the Relation of Monographies of Active Ingredients of Pesticides, Household Cleaning Products and Wood Preservers:-includes the pea culture with MRL of 0,1 mg/kg and safety security period of 7 days in the modality of foliar use (application);-includes the ground-nut culture with MRL of 0,1 mg/kg and safety security period of 7 days in the modality of foliar use (application);-includes the caupin bean culture with MRL of 0,1 mg/kg and safety security period of 7 days in the modality of foliar use (application);-changes the MRL of the soya culture from 0,05 to 0,06 mg/kg in the modalities of foliar and seed use (application);-changes the MRL of the ground-nut culture from 0,01 to 0,1 mg/kg in the modality of seed use (application).

Products Covered: HS Code(s): 070810, 200811, 1201, 07133500; ICS Code(s): 13, 65

Regulation Type: Regular notification