On 30 Mar 2018, Korea officially enacted the “Law 15511-Act on the Safety Management of Household Chemical Products and Biocides (K-BPR)”, which will take effect on 1st Jan 2019. The regulation majorly governs the labeling, approval, authorization and post-management of household chemical products, biocidal products and biocide-treated articles.

By the end of 2017, 37888 pesticides registered by 2213 companies were within their validity, of which 3913 pesticides of 1216 companies were newly approved in the past several years. China promulgated a new pesticide regulation and revoked temporary registration. Applications which were being processed at the time of promulgation of the new regulation are still being reviewed and approved based on requirements of the previous regulation: 3365 were full registration for field use, 385 were temporary registration for field use, 153 were full registration for hygienic pesticide and 10 were temporary registration for hygienic pesticide.

On 28 Nov 2017, China MoA’s Website released Order 8 of 2017 regarding the amendment and annulment of several ministerial regulations and other regulatory documents, of which 2 are amendments to fertilizer registration. The most notable changes are that temporary registrations are removed from the registration scheme and also there is a broadened acceptance scope of efficacy trail report.

On 10 Jan 2018, China MoA’s website released announcement 2622 to promulgate 87 agricultural standards which became effective on 1st of Jan 2018. Among them, 21 standards are for the regulatory studies required during registration of pesticides and fertilizers.

On 23 Jan 2018, China MoA’s website released 6 guidance documents to clarify the administrative formalities of pesticide and fertilizer registration. The documents are compiled as per the requirements of State Council on standardization of administrative approval.

Since the Nov 1st 2017 implementation of  "MoA Announcement 2569-Data Requirements on Pesticide Registration", subsequent registration applications have been subject to increased data requirements and elevated criteria. Other changes include but not limited to the abolishment of temporary registration and mandatory risk assessment. Compared with the previous regulation, MoA Order 10 of 2008, Announcement 2569 includes significant improvements in text structure and information transparency. A comparative analysis between the new and old version offers useful information to aid companies in adapting to new requirements. Chapter Reorganization in Regulation Text In the 2008 version, hygienic pesticides, rodenticides, biochemical pesticides, microbial pesticides, botanical pesticides, GMOs and natural enemy pesticides are defined as special pesticides and their registration requirements were incorporated in an independent chapter similar to the individual chapters  detailing requirements of new active ingredients, new formulated pesticides, me-too and technical concentrations(TKs). In the main body, each of these chapters consists of 3 sub-chapters, corresponding to the requirements for field trial application, temporary registration and full registration. In the new data requirements, three types of biopesticide have equal chapter allocation as chemical pesticides. The requirements for manufacturing “use product” (TC/TK) and end-use product (formulation) are respectively compiled in 2 sub-chapters.  Furthermore,  “atypical” products including agricultural GMOs and natural enemies have been removed from the new data requirements. GMOS are regulated under agricultural GMO regulations and natural enemies are subject to significantly decreased registration data requirements. Conditions for post registration including use scope expansion, amendment to application method and dose are refined in Chapter VI

1.[EU BPR]The First opinion on Union authorization was adopted The Biocidal Products Committee (BPC) supported applications for EU-wide access to the market  of two biocidal product families containing iodine/PVP-iodine for use in veterinary hygiene on 20 December 2017. It is the first opinion supporting applications for Union authorization which means that it is realized successfully that companies are allowed to place their biocidal products on the market throughout the entire Union with one authorization form. 2.[US EPA-FIFRA]Pesticide Registration Improvement Extension Act (PRIA 4) will recently be updated PRIA 3 is about to expire and PRIA 4 will enable after PRIA 3 is invalid. While PRIA 3 was originally set to expire December 8, 2017, now for the duration of that Continuing Resolution period, it has been extended until January 19, 2018. When PRIA 4 is expected to be enabled, a number of new registration types, such as disinfectant devices identification, will be added, as well as additional review costs. 3.[Chinese disinfectant products] The relevant standards for relevant Chinese disinfectant products are to be issued. NHFPC (National Health and Family Planning Commission) is working to formulate or revise relevant standards for disinfection products, including the classified catalogue of disinfection products, hygienic safety evaluation, test contents, disinfecting wipes, etc. These are expected to be announced in the first half year of 2018. 4.[EU BPR]Draft guidance for identifying endocrine disruptors was issued This draft guidance for identifying endocrine disruptors which will be used to evaluate pesticides and biocides has been developed by the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) with the support of the Commission’s Joint Research Centre (JRC). ECHA and EFSA are inviting interested parties to comment on the draft guidance document for the identification of endocrine disruptors under EU legisl

On 29 Dec 2017, China ICAMA opened a 60-day consultation on the” Pesticide guidelines for large area field efficacy trials”. China implemented new registration data requirements on 1 Nov 2017 in which a 1-year large area efficacy trial conducted in 2 different administrative regions will be required for registration of new agricultural and environmental use pesticides of chemical, biochemical, microbial and botanical origin.

On 25 Dec 2017, China MOA and MEP jointly solicited public comments on a draft of “Administration Measures for the Recycling and Disposal of Pesticide Packaging Waste”. The draft defines the obligation and requirements on the collection, transportation, transfer, storage and disposal of pesticide packaging waste. The expense will be borne by pesticide producers and dealers.

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 Decree 677- Regulation on the Administration of Pesticide MoA Order 3 of 2017 "Administrative Measures for the Registration of Pesticide" MoA Order 4 of 2017 "Administrative Measures for the Production License of Pesticide" MoA Order 5 of 2017 "Administrative Measures for the Marketing License of Pesticide" MoA Order 6 of 2017 "Administrative Measures for the Registration Experimentation of Pesticide" MoA Order 7 of 2017 "Administrative Measures for Pesticide Labels and Manuals" MoA Announcement 2569 "Data Requirement on Pesticide Registration" MoA announcement 2567-"Catalogue of Restricted Pesticides (Version 2017)" MoA announcement 2568-" Rules for the Inspection on Pesticide Production License"; MoA announcement 2579-"Announcement concerning the Format and Generation of 2D Codes on Pesticide Labels";  MoA announcement 2570-"Rules for the Accreditation on Testing Facilities for Pesticide Registration & Good Laboratory Practice for the Experimentation of Pesticide Registration" (2 document)