How to Place on the Market of Household Pesticides in China

Transcription

1 How to Place on the Market of Household Pesticides in China Qiu Jianping Beijing Sail-go Consulting Co., Ltd. September 2nd, 2014 Singapore 1

2 Contents What is Biocide Biological Pesticides in China How to register Household pesticide in China TC How to register Household pesticide in China Formulation product Test Guidelines for Pesticide Registration in China How to export the registered Household pesticide to China Label management Distribution Channel and Association of Household pesticide in China Consumers of Household pesticides in China 2 About Sail-go

3 What is Biocide EU China Biocides are active substances and products which are intended to destroy (...) any harmful organism by chemical or biological means. Biocides represent a wide range of products e.g. disinfectants, wood preservatives, rodenticides, antifouling agents (on boats), in-can preservatives, used in homes, public places such as hospitals, and industries, to destroy and control viruses, bacteria, algae, moulds, insects, mice or rats. They help inter alia prevent the spread of diseases and food poisoning. No EU special Biocides definition Regulations for Biocide, (BPR) they are governed by different departments by their usage. Ministry of Agriculture (MOA) in charge the registration of Pesticide, and appoints the Institute for the Control of Agrichemicals, Ministry of Agriculture (ICAMA) to take the registration work and management work in details. Some of biocide are belonged to Pesticide in China - Public health pesticide (Sanitary pesticide / household pesticide), including wood preservatives, used in homes, public places such as hospitals, and industries, to destroy and control algae, moulds, insects, mites, ants, and termites, etc. AND Rodenticides, to control mice or rats at indoor or open field, etc. Besides of crop used pesticides, MOA gives other classifications, i.e. Public health pesticide, rodenticide, biochemistry pesticide, microorganism pesticide, Botanical pesticide, GMO pesticide and natural enemy pesticide, etc. China Pesticides Management Act 3 (2007),

4 Biological Pesticides in China Definition for Pesticides (not including crop used products) Public health pesticide means the pesticide to prevent, kill or control mosquito, flies, cockroaches, ants and other pests in the human environment and the animal environment of breeding industry belong to the agriculture and forestry Industry. Rodenticide means the pesticide to prevent, kill or control harmful rodent such as rats. Biochemistry pesticide is one sort of biological pesticide. It meets the following two conditions: -- No direct toxicity to the control objects, but has special functions of growth adjustment, interference of mating and attraction. -- Be natural compound; if it is synthetic, its structure must be the same as natural compound (proportion difference of isomer ratio is allowed). Includes: Pheromone, Hormone, Natural Plant Growth regulator (PGR) and Insect Growth Regulator (IGR) and Enzyme Botanical pesticide means the pesticide with active ingredient from plant. Microbial pesticide is one sort of biological pesticide, including the formulations naturally produced by bacteria, fungi, virus and protozoa or microorganism modified by gene etc., to control harmful organisms such as insect, weed and rats etc. Genetically modified organism (genetically engineered microorganisms, GEMs) - Organism with transformed gene is agricultural biology which makes use of external genetic engineering technology to change gene group s structure, controls the harmful organisms and resists herbicide, etc. Natural enemy pesticide is the commercialized (except Microbial pesticide) organism living body which has the function of controlling harmful organism, such as disease, pest and weed etc. 4

5 Biological Pesticides in China Definition of biological pesticides by ICAMA There is no clear definition of biological pesticides from the MOA / China Pesticide Management Act, ICAMA classified some of pesticides to be biological pesticides; ICAMA biological pesticides indicates: the commercialized pesticide formulations which originated from organism or their metabolites, or GEM products. Including: - Microbial pesticide; - Biological chemical pesticide; - Botanical pesticide; - Natural enemy pesticide; - GEMs pesticide, and - Antibiotic pesticide (there is possibility it will be classed as biological pesticides in the future) 5

6 Biological Pesticides in China The basic information of biological pesticides in China* Company No. for producing Microbial pesticide, Biological chemical pesticide and Botanical pesticide: > 200 Company No. for producing Antibiotic pesticide: > 1700 Reg. a.i.: > 90 Reg. products: > 3,000 % of reg. biological pesticides of all pesticides: 11-13% % of reg. Antibiotic pesticide of biological pesticides: about 70% Annual production: about 120,000 t (2012) Using area: 26.7 million ha % of Market Share of all pesticides: about 5% * ICAMA data, May,

7 Biological Pesticides in China The reg. biological pesticides in China* Classification No. of a.i. Microbial pesticide Biological chemical pesticide Botanical pesticide No. of reg. product s Antibiotic pesticide Natural enemy pesticide 2 4 Total * ICAMA data, May, Antibiotic pesticide: 72% Biological chemical pesticide: 11% Microbial pesticide: 10% Botanical pesticide: 7%

8 Biological Pesticides in China The future policies MOA / ICAMA will give more clear policies for Biological pesticide to allow the applicants to submit less data/tests to get registration. - TC/TK? - Toxicological data? - Environmental data? - Residue data? - 8

9 How to register Household pesticide in China (Steps) TC - Apply for Temporary registration - for new a.i. which have no permanent registration product), or - Apply for Permanent registration directly - for a.i. which have one or more permanent registration products; or the TC has got the temporary registration for 3 years. Formulation - Apply for EUP firstly, and - Apply for Temporary registration - for new formulation which have no same product (same a.i., formulation type and content of a.i.) got the permanent registration), or - Apply for Permanent registration directly - for the formulation which 9 have one or more same products got permanent registration, or

10 How to register Household pesticide in China - TC (for foreign products) Product Chemicals Data - a.i. s information The common name (in English and Chinese), chemical name, CAS number, CIPAC code number, development code of the applicant, empirical formula, relative molecular weight, structure formula, main physical-chemical parameters (such as: appearance (color, physical state and odor etc.), melting point / boiling point, density / bulk density, specific optical rotation, vapor pressure, solubility, and partition coefficient, etc.). - TC s information - The test methods and results for the following parameters should be provided: appearance, density / bulk density, viscosity, flammability, corrosion, explosion, flash point and the miscibility with other pesticides, etc. - Product components (all components, a.i.: >=?%, related impurities: =<?%) - The physical-chemical properties of TC - Specifications (The content of the relevant impurities*) - Test analyze reports (batches, methods, results) * 5-batchs analysis (a.i., 0.1% impurities, relevant impurities), * Specifications, qualitative analysis, quantitative analysis, spectrums * Quality inspection report, test method validation report, etc. - Manufacturing process - Packing information 10

11 How to register Household pesticide in China - TC (for foreign products) Toxicology dada (1) - Acute Toxicology tests (Total 6 items) * Acute oral, dermal and inhalation toxicity; * Skin and eye irritations; * Skin sensitization. - Subchronic /subacute toxicity tests * 90- day feeding experiment for rats; * 28 days dermal - For the TC to be processed into formulation that could be inhaled repetitive, such as Mosquito coil, Aerosol and Mothproofing agent; * 28 days inhalation - For the TC to be processed into formulation that could be contacted with skin in a long-term, such as Repellent. - Mutagenicity tests * Salmonella Typhimurium / reverse mutation assay; * In vitro mammalian cells gene mutation test; * In vitro mammalian cells chromosome aberration test; * In vivo mammalian bone marrow cells micronucleus test. 11

12 How to register Household pesticide in China - TC (for foreign products) Toxicology dada (2) - Delayed neuron toxicity test (for OPS only). - 6 months Subchronic toxicity test - Reproduction toxicity test # - Teratogenicity test # - Metabolism in animals # - Survey data about the human contact situation # - Toxicity data for relevant impurities - Acceptable daily intake (ADI) or temporary ADI (TADI) data - 2 years chronic and carcinogencity test # - Toxic symptoms and first aids # If the a.i. of TC has been recommended using by World Health Organization (WHO) for controlling public health pests and media organisms and/or it belongs the pyrethroids pesticide, the tests are not need. 12

13 How to register Household pesticide in China - TC (for foreign products) Efficacy data - Action mode, action spectres, mechanism or its prediction analysis # # for new a.i. / control pest / within the data protection period (6 years) products only 13

14 How to register Household pesticide in China - TC (for foreign products) Environmental data - For the a.i. / formulation will be used in outdoor: - For the a.i. / formulation will be used in indoor only: Volatility test; Volatility test; Soil adsorption test; Hydrolysis test; Soil degradation test; The photodegradation test in water; Hydrolysis test; Toxicity test for silkworm. The photodegradation test in water; Water - sediment degradation test; * Some tests could be derated according Acute oral toxicity test for birds; to the different pesticide properties or Acute toxicity test for fish; using purposes. Acute toxicity test for daphnia; Acute toxicity test for algae; Acute oral / contact toxicity tests for bees; Acute toxicity test for silkworm. * Some tests could be derated according to the different pesticide properties or using purposes. 14

15 How to register Household pesticide in China - TC (for foreign products) Other data - Application form - Product summary - MSDS - Registration in other countries - Draft label in Chinese market - Introduction of the applicant - Others 15

16 How to register Household pesticide in China - Formulation product / End used product(for foreign products) Product Chemicals Data - Brief introduction for a.i. and TC s information - Formulation product s information - Product components (all components: >=0.1%) - The physical-chemical properties - Specifications (The content of the relevant impurities*) - Analyze test reports (batches, methods, results) * Specifications, quantitative analysis, spectrums * Quality inspection report, test method validation report, etc. - 3 batches of test report for long-term (2 years) at room temperature storage stability (for new formulation products and/or the products within the data protection period (6 years) ), or - 3 batches of test report for 30, 18 weeks accelerated storage (for Metoo products and exceed the data protection period (6 years) ) - Manufacturing process - Packing information 16

17 How to register Household pesticide in China - Formulation product / End used product(for foreign products) Toxicology dada - Acute Toxicology (Total 7 items) * Acute oral, dermal and inhalation toxicity; * Skin and eye irritations; * Skin sensitization, and * Multiple skin irritation (for the formulation which can be contacted repeatedly ) * Some tests could be derated according to the different pesticide formulation types or using purposes: > Smoke coil, vaporizing mat: acute inhalation toxicity; > Aerosol: acute inhalation toxicity, eye and skin irritation; > Liquid vaporizer: acute oral, dermal and inhalation toxicity; > Repellent: acute oral, dermal and inhalation toxicity, eye irritation, multiple skin irritation and sensitization. > Other formulation types: acute oral, dermal and inhalation toxicity, eye and skin irritation, and sensitization. 17

18 How to register Household pesticide in China - Formulation product / End used product(for foreign products) Efficacy data - Action mode, action spectrum, mechanism or its prediction analysis # - Indoor bioassay test report /Indoor formula-screening test report, to obtain the data of median knockdown time (KT 50 ) or median lethal time (LT 50 ), median lethal dose (LD 50 ) or median lethal concentration (LC 50 ), and mortality, etc. # - The available efficacy reports in other countries or regions - Control pests, application methods and notes, etc. - The illumination for the mixing purpose (for the mixture formulation products only) - Efficacy test reports for 1 year and 2 provinces sites, and efficacy test reports for 1 year and 2 provinces analogous sites (for indoor use formulation products only), or - Efficacy test reports for 1 year and 2 provinces sites, and field test reports for 1 year and 2 provinces field sites (for outside use and for controlling termite products only). # For new a.i. / new controlled pest / within the data protection period (6 years) products only 18

19 How to register Household pesticide in China - Formulation product / End used product(for foreign products) Environmental data - For the formulation products will be used in outdoor: Acute oral toxicity test for birds; Acute toxicity test for fish; Acute toxicity test for daphnia; Acute toxicity test for algae; Acute oral / contact toxicity tests for bees; Acute toxicity test for silkworm. # * Some tests may be derated according to the pesticide properties, formulation types, application scopes and application methods, etc. * If the pesticide TC is low toxic to algae or daphnia, and the summary TC s data of the test has been provided, the test report of formulation for this kind of organism is not necessary. * If the pesticide formulation is for slow release, the test reports for soil degradation and soil adsorption should be provided. not necessary, - For the formulation products will be used in indoor only: Acute toxicity test for silkworm. # * This test may be derated according to the pesticide properties, formulation types, application scopes and application methods, etc. # For the formulation products processed by the pyrethrum a.i., the toxicity test for silkworm is but the text of High toxic to silkworm and the safety use instruction should be marked in the 19 label.

20 How to register Household pesticide in China - Formulation product / End used product(for foreign products) Other data - Application form - Product summary - MSDS - Registration in other countries - Draft label in Chinese market - Introduction of the applicant - Certification of the TC s source - Others 20

21 How to register Household pesticide in China - Formulation product / End used product(for foreign products) Some information to be concerned: - For the pesticide with the content of isomers a.i. is lower than 1%, if the applicant made out the illumination of the identification experiment for the a.i. (including the identification of the isomers), the relevant splitting method of the isomers in the formulation could be not provided. - For the Coil formulations, the a.i. content should be not more than 40% of the nominal value, and no less than 20% of the nominal value. - For Aerosol formulations, the name and content of the propellant should be regulated. The chlorofluorocarbon (CFC) could not be a propellant. - ICAMA prefers to register the lower a.i. content of household products for the safety using reason if the efficacy test result is satisfied. - ICAMA has began to the project of Risk Assessment for some household products: a.i./formulation, using method/using rate, user/animals, toxicity/environmental, etc. The WHO document and the detail data generated by the applicant and/or the special test are every important for this work. - Each registration product is not permitted to has more than 3 types of scents. 21

22 ICAMA can approve the using dosage which not higher than the recommendation in the WHO s document; If the applied a.i. does not listed in the WHO s document, the applicant will have to submit more data to ICAMA, and discuss with them. 22

23 The requirements for the content ranges of a.i. in china Declarable content X (% or g/100ml, 20 ± 2 ) X 2.5 (for formulation products) 2.5 < X 10 ±10% X 10 < X 25 ±6% X 25 < X 50 ±5% X Allowed fluctuation range ±15% X, for homogeneous formulations, such as EC, SC and SL, etc.) ±25% X, for nonhomogeneous formulations, such as GR and WG, etc.) X > % or 2.5g/100mL 23

24 Toxicity classification and symbols for pesticides in China Toxicity classification Classification name Oral LD 50 (mg/kg) Dermal LD 50 (mg/kg) Inhalation LC 50 (mg/m 3 ) Symbol Description in the label Remark Ⅰa Acute toxic Acute toxic Ⅰb High toxic >5~50 >20~200 >20~200 High toxic The Symbol will be printed in BLACK Medium Ⅱ Medium toxic >50~500 >200~2000 >200~2000 toxic >500~ >2000~ Ⅲ Low toxic >2000~5000 / Ⅳ Minor toxic >5000 >5000 >5000 / Minor toxic The Description will be printed in RED, under the Symbol 24

25 Test Guidelines for Pesticide Registration in China Guidelines for toxicity tests - e.g. Toxicological test method of pesticides for registration (GB ) Guidelines for efficacy tests - e.g. Laboratory efficacy test methods and criterions of public health insecticides for pesticide registration (GB/T ) Guidelines for product chemicals test - e.g. Testing method for the storage stability at elevated temperature of pesticides (GB/T ) Guidelines for environmental tests - e.g. Test guidelines on environmental safety assessment for chemical pesticides, Part 11: Silkworm acute toxicity test (Draft) Guidelines for the certain formulation - e.g. Domestic sanitary insecticide Electrothermal vaporizing mats (GB/T ) Guidelines for the certain product - e.g. Fungal pesticide Beauveria bassiana (NY/T ) GB- National standards HB-Industry standards Q/- Enterprise standards China has set up a fairly complete guidelines system for pesticides producing, testing and registration; Most tests have developed the testing guidelines; Many testing guidelines in China are coordinate/similar with them in OECD, USA, and Japan, etc.; China accepts most test reports which conducted 25 at GLP labs and based on the guidelines of OECD, USA, and Japan, etc. if they are GLP reports.

26 The cover pages of Chinese national standards 26

27 How to export the registered Household pesticide to China Ensure the registration product is in validity period (it s better at least 3 months ahead to maturity); Apply the Import Pesticides Release Permit to ICAMA - The product s registrar should has been put on recorder by ICAMA - The importer should has been put on recorder by ICAMA - The issuer of Quality Warranty Letter should has been put on recorder by ICAMA - Some necessary document, such as the Waybill and Contract, etc. - One batch import, one permit by ICAMA The importer go to the 27 local customs to take

28 28 ICAMA issued the Import Pesticide Release Permit, showed: the importer s information, the producer s information, the product s information, and the local customs information, and valid period, etc.

29 Label management ICAMA approve the pesticide labels (all the text, some of layouts and some of the artwork) based on the Administer method of Pesticide label and instruction Management. If the applicant wants to change any text on the label, it must be approved by ICAMA firstly. When the applicant applies for renewal the registration of the product, the Chinese market label should be provided if the product is sold in China. ICAMA published the approved labels (only for the text) at: It will be used for checking by anyone and helped for marketing supervision. 29

30 Distribution Channel and Association of Household pesticide in China Distribution Channels - Super market (top grade products) - Store (regular to top grade products) - Rural fair (cheap to regular grade products) - Internet (all grades products) - Governments purchasing (National Patriotic Health Campaign Committee, Stations for Schistosomiasis Control, CDC, etc.,) - Routine tasks - Special tasks (Olympic Games, Disaster relief, etc.) Association Sub-association for household products of China household necessities Industry Association 30

31 Consumers The market capacity for household products is reducing in this years because the environmental hygiene are better than before, especially for mosquito and flies; but the cockroach is growing up in house / city. Consumers in city prefer to use healthful and convenient products, such as Aerosol, Electric vaporizing mat, Electric vaporizing liquid, Repellent products, etc., there is a possibility some new formulation types and designs will become popular. Consumers in country side prefer to use Mosquito coil and Aerosol because they are cheaper and have the good efficacy. 31

32 About Sail-go Beijing Sail-go Consulting Co., Ltd. established in 2003; We guide our clients to Do right things, and Do things right! Add: Room 1503B, Wisdom Plaza, No.38, Xueyuan Nan Road, Haidian District, Beijing, China, Tel: (8610) , , , Website: Has successfully helped our clients to get more than 10 new a.i. and their products reg. in China, and there are more than 15 new a.i. and their products are in the process of reg. By Sail-go in China 32

33 Thanks for your attention! 33