REACH24H Annual Review: Top 10 News on Global Pesticide Management

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No.1 Top-down Renewal of Pesticide Regulations in China

On 8 Feb 2017, China’s State Council approved the revised draft of “Regulation on the Administration of Pesticides”, which was implemented as of 1 Apr. Thereafter, 5 administrative measures were released in the form of ministerial regulations concerning the registration experimentation, registration, production, marketing and labeling of pesticide. On September, 6 supporting documents were issued under series of MoA Announcements. These productive legislative actions constitute a comprehensive regime of product registration and 3-element licensing system of pesticide:

State Council Decree

Ministerial Regulation

MoA Announcement

  1. MoA Order 3 of 2017 "Administrative Measures for the Registration of Pesticide"
  2. MoA Order 4 of 2017 "Administrative Measures for the Production License of Pesticide"
  3. MoA Order 5 of 2017 "Administrative Measures for the Marketing License of Pesticide"
  4. MoA Order 6 of 2017 "Administrative Measures for the Registration Experimentation of Pesticide"
  5. MoA Order 7 of 2017 "Administrative Measures for Pesticide Labels and Manuals"
  1. MoA Announcement 2569 "Data Requirement on Pesticide Registration"
  2. MoA announcement 2567-"Catalogue of Restricted Pesticides (Version 2017)"
  3. MoA announcement 2568-" Rules for the Inspection on Pesticide Production License";
  4. MoA announcement 2579-"Announcement concerning the Format and Generation of 2D Codes on Pesticide Labels";
  5.  MoA announcement 2570-"Rules for the Accreditation on Testing Facilities for Pesticide Registration & Good Laboratory Practice for the Experimentation of Pesticide Registration" (2 document)

No.2 U.S. Pesticide Registration Improvement Extension Act (PRIA 3) to be renewed

The expiration date of PRIA 3 has been further extended by the Continuing Resolution signed on December 22, 2017, for the duration of that Continuing Resolution period until January 19, 2018. The authority will collect maintenance fees at the level specified in PRIA 3, as well collecting PRIA Registration Service fees at the FY'17 levels, until January 19, 2018.

No.3 Non-renewal of Linuron, Picoxystrobin and Iprodion in EU

The EU commission has issued the implementing regulation 2017/244, 2017/1455 and 2017/2091 on the non-renwal of Linuron (herbicide), picoxystrobin(fungicide) and Iprodion(Fungicide). Furthermore, EU voted only a five-year renewal of glyphosate and glufosinate formulations. These formulations have been prohibited in France.

No.4 China to Form New Authority for Pesticide Management

The SCOPSR (State Commission for Public Sector Reform) office has recently approved the establishment of a new authority called “Pesticide Management Agency” operating under MoA’s Department of Plantation Management. The new authority will take over responsibilities previously delegated to MIIT and AQSIQ related to production management and take comprehensive charge of industrial planning, administrative approval, supervision and sanctions in the pesticide sector.

No. 5 China to Reduce New Approval of Me-too Registrations by 30% by 2020

China MoA has consulted on industrial developmental program aimed at safety and environmental improvements in pesticide production sectors. In the new data requirement, China elevated the criteria for me-too registration and the new approval of generic pesticide will reduce by 30% by 2020 and 50% by 2025. Highly toxic pesticides will be phased out while biopesticides and green pesticides will be prioritized.

No.6 China: Stringent Environmental Supervision on Pesticide Production

In 2017, China MEP consulted on 2 environmental regulations targeting pesticide producers: the “Effluent Standards for Pollutants for Pesticide Industry” and the “Technical Specification of Application and Issuance of Pesticide Pollutant Permit”. Two drafts specified the typical and universal pollutants/environmental indicators, information requirement, determination method of emission limits, computation of actual emission, criterion to assess environmental violation, as well as the technical requirements on self-inspection, ledger of environmental management and performance reporting of pollutant permit for pesticide (intermediate) production. A mandatory measure called off-peak production has been adopted in Northern China starting from 15 Nov 2017 to 15 Mar 2018. Pesticide producers in 34 cities in 8 provinces have been affected and high prices are expect to continue throughout next year. ( China’s Pesticide Price Hikes Aggravated by Heating Season Environmental Policy ).

No.7 EU Invited Public Consultation on EDC Draft Guidance

On December 7, 2017, the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) opened a public consultation on the draft guidance document for the implementation of the criteria to identify endocrine disrupting chemicals (EDCs) in the field of pesticides and biocides. The draft guidance was requested by the European Commission (EC) and prepared by EFSA and ECHA with support from the EC’s Joint Research Centre (JRC). The deadline for submitting comments is January 31, 2018. “All comments will be taken into consideration in the finalization of the guidance,” EFSA stated. The final guidance document is scheduled to be published by June 2018, ECHA informed.

In November 2017, the EC published the regulation setting out criteria to identify EDCs in the field of biocides, which will enter into force on December 7, 2017 and apply from June 7, 2018. In October 2017, the European Parliament rejected the EC’s proposal for similar criteria in the field of pesticides. The EC now has to revise the EDC criteria for pesticides and a new proposal will be discussed with Member States on December 12-13, 2017.

No.8 US EPA Releases Draft Risk Assessments for Glyphosate

The U.S. Environmental Protection Agency (EPA) is releasing for public comment the draft human health and ecological risk assessments for glyphosate, one of the most widely used agricultural pesticides in the United States.

The draft human health risk assessment concludes that glyphosate is not likely to be carcinogenic to humans.  The Agency’s assessment found no other meaningful risks to human health when the product is used according to the pesticide label.  The Agency’s scientific findings are consistent with the conclusions of science reviews by a number of other countries as well as the 2017 National Institute of Health Agricultural Health Survey.

No.9 China Formed 9th National Pesticide Registration Committee

On 27th Nov 2017, China MoA officially released the expert panelists of the 9th National Committee on Pesticide Registration. The panelists were nominated on commendation made by government department including MIIT, MEP, NHFPC, AQSIQ, SAWS and CFDA to fit specific personnel composition requirements as designated by the MoA early this year and publically consulted on 17 Oct (China MoA Consults on Personnel Composition of 9th National Pesticide Registration Committee). The new committee technical advice in accordance with the new data requirement, which has entered into force on 1 Nov 2017.

No.10. Acetochlor added under Rotterdam and Stockholm Conventions

The 13th meeting of the Chemical Review Committee (CRC) of the Rotterdam Convention at Rome have recommended inclusion of phorate, acetochlor and hexabromocyclododecane in Annex III of the Convention

 

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