ANSES withdraws marketing authorisation for Basta F1, a plant protection product containing glufosinate

On 24 October 2017, ANSES withdrew the marketing authorisation for the only plant protection product containing glufosinate authorised in France, Basta F1, marketed by Bayer SAS, as well as the import permits for products containing it. Following a re-examination of the marketing authorisation for this product, the Agency concluded that risks to the health of users, workers and people in the vicinity of treated areas could not be ruled out. ANSES conducted a review of the dossier submitted by Bayer SAS with a view to renewal of the marketing authorisation (MA) for the product BASTA F1, a herbicide containing glufosinate-ammonium, used as a spray on vines, orchards, vegetables and potatoes. Taking into account all the available scientific data and the most recent risk assessment models, the Agency considered that the risks to human health associated with exposure to glufosinate, a substance classified as R1B for its presumed reprotoxicity, could not…

Nov. 13th, 2017

Food Contact Notification(FCN) News in May

According to FDA official website, 6 food contact notifications (FCN) have been approved by FDA in May, and their information is shown in the table below: Notifier Effective Date Name of The Substance Intended Use Limitations/Specifications Zhejiang Transfar Whyyon Chemical Co. Ltd. May 3, 2017 Benzenesulfonic acid, 2,2′-(1,2-ethenediyl)bis(5-((4-(bis(2-hydroxyethyl)amino)-6-((4-sulfophenyl)amino)-1,3,5-triazin-2-yl)amino)-, tetrasodium salt (CAS Reg. No. 16470-24-9). As an optical brightener in paper and paperboard, except for use in contact with infant formula and human milk (see Limitations/Specifications). For use in paper and paperboard complying with 21 CFR 176.170 in contact with all food types at levels not to exceed that necessary to achieve the desired technical effect, except for the following: When the substance is used in uncoated paper and paperboard intended for contact with Food Types I, II, IV-B, VI and VII-B, the brightener is limited to use at levels not to exceed 0.5 pound per ton of paper; and When…

Jun. 19th, 2017

Food Contact Notification(FCN) News in April

According to FDA official website, 3 food contact notifications (FCN) have been approved by FDA in April, and their information is shown in the table below: Notifier Effective Date Name of The Substance Intended Use Limitations/Specifications Henkel, Inc. Apr 15, 2017 Polyester-polyurethane adhesive formulated from the following: Polyurethane component prepared from allophanate-modified methane diphenyl diisocyanate, 4,4′-diphenylmethane diisocyanate (CAS Reg. No. 101-68-8), propylene oxide, ethylene oxide, 1,2-propanediol, hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2), and hexamethylene diisocyanate (CAS Reg. No. 8222-06-0) and Polyester/polyether/polyol component prepared from adipic acid (CAS Reg. No. 124-04-0), 1,3-benzenedicarboxylic acid (CAS Reg. No. 121-91-5), diethylene glycol (CAS Reg. No. 111-46-6), 1,2-propanediol (CAS Reg. No. 57-55-6), polypropylene glycol (CAS Reg. No. 25322-69-4), and 1,2,3-propanetriol (CAS Reg. No. 56-81-5). The FCS Is intended to be used as an adhesive in laminate structures intended for contact with food, except for use in contact with infant formula and human milk (see…

Jun. 19th, 2017

Food Contact Notification（FCN）News in March 2017

According to FDA official website, 6 food contact notifications (FCN) have been approved by FDA in March, and their information is shown in the table below: Notifier Effective Date Name of The Substance Intended Use Limitations/Specifications CraftChem, Inc. Mar 18, 2017 An aqueous mixture of peroxyacetic acid (CAS Reg. No. 79-21-0), hydrogen peroxide (CAS Reg. No. 7722-84-1), acetic acid (CAS Reg. No. 64-19-7), 1-hydroxyethylidine-1,1-diphosphonic acid (HEDP) (CAS Reg. No. 2809-21-4), and optionally sulfuric acid (CAS Reg. No. 7664-93-9). As an antimicrobial agent in process water used to wash raw and processed fruits and vegetables in food processing facilities. The components of the FCS mixture will not exceed 350 ppm peroxyacetic acid, 117 ppm hydrogen peroxide, and 4 ppm HEDP. DSM Engineering Plastics B.V. Mar 22, 2017 1,4-Benzenedicarboxylic acid, polymer with 5-amino-1,3,3-trimethylcyclohexanemethanamine and hexahydro-2H-azepin-2-one (CAS Reg. No. 1105025-82-8). The FCS will be used as a component of articles used in contact…

May. 22nd, 2017

Chinese New Pesticide Regulation: Inter-Departmental Comments on 5 Draft Supporting Rules

On 1 April, China MoA (Ministry of Agriculture) released the drafts of 5 supporting regulations for the newly promulgated pesticide regulation, which were currently under internal consultation among governmental departments including NDRC, MIIT, MPS, MEP, MOFCOM, NHFPC, SAIC, AQSIQ, SAWS, SFDA, SFB (State Forestry Bureau), SGB (State Grain Bureau), GSMC (General Supply and Marketing Cooperative) and all provincial agricultural departments. The 5 supporting drafts will be issued under ministerial regulation, which reflects the regulatory prospects of pesticide regulation, production, marketing, label and manual, as well as the accreditation of pesticide labs: Administrative Measures for the Registration of Pesticide; Administrative Measures for the Production of Pesticide; Administrative Measures for the Marketing of Pesticide; Administrative Measures for the label and Manual of Pesticide; Administrative Measures for the Testing Facility of Pesticide Registration; News Source: ChemLinked

Apr. 17th, 2017

Analysis of Chinese New Pesticide Regulation: Risk Assessment and Benefit Evaluation Firstly Required

According to the draft of “Administrative Measures for the Registration of Pesticide”, the “Risk Assessment Report” and the” Benefit Evaluation Report” will be required for pesticide registration. The reports should be fully supported by the product chemical, toxicological, efficacy, ecotoxicological and environmental properties, aims at demonstrating the safeness, efficacy and economic advantages over registered product. Besides, MoA will maintain updating on the “List of Restricted/Prohibited Inert Ingredients (Adjuvant)” in accordance with the hazard and toxicity characters of inert ingredient. If the inert ingredient was exclusively used for the formulation, additional testing report on the inert ingredient will be required. All registered pesticides are subject to safety risk surveillance system and pesticide active ingredients which have been registered for over 15 years will be periodically revaluated by MoA. The number of registration will be further decreased by the limitation on content level. Accoding to the MoA Announcement 946 and Announcement 1158, pesticide with same…

Apr. 17th, 2017

Chinese New Pesticide Regulation: GLP MAD to be Promoted

MoA will accept the study report on product chemistry and toxicity obtained by overseas GLP-compliant laboratories from a country which has mutual or multilateral agreement on data acceptance with China. While the study on efficacy, residue and environmental impact must be carried out in China. The draft of supporting rules will also accelerate the new establishment of more national MRLs (Maximum Residue Limits) and facilitate China’s contribution to the formation of international residue standards. If a pesticide was firstly registered on a crop, a suggestive MRLs should be proposed after its dietary risk assessment. For active ingredients and crops which China has already established MRL, a validation study will sufficient. If the established MRL was based on residue data which was generated outside China, the applicant will be required to conduct the study in China. News Source: ChemLinked

Apr. 17th, 2017

Chinese New Pesticide Regulation: Pesticide Marketing and Labeling

Literally interpreted, the range of pesticide marketing has been broaden from only 7 types of entities(marketing entities under the state owned supply and marketing cooperatives, plant protection station, soil& fertilizer station, agricultural and forestry technology extension organization, pesticide production enterprises and other entities prescribed by the State Council) to all entities equipped with qualified technicians(56 hour professional training), operating area(no less than 30 square meters) and storage area(no less than 50 square meters),  ventilation and firefighting facility, bar code identification device and computerize systems. For online sales of pesticide, the marketing license number, registered address and contact information will be mandatorily displayed on webpages. If specific product was exhibited, the pesticide registration number, production license number and photo of label should be displayed. Electronic traceable code will be mandatorily included in pesticide labels. In addition, specific information should be labeled for quality assurance and safety consideration: Technical product should be labeled with “For Formulation Use…

Apr. 17th, 2017

China Promulgates New Pesticide Regulation

From June 1st 2017, China’s Ministry of Agriculture will be the sole regulatory authority empowered to undertake supervision and enforcement of regulations related to pesticide registration, production and issuance of the marketing license; The cancellation of temporary registration will help to eliminate a large number of low technical capacity enterprises from China’s pesticide markets and reduce the number of registered products; Domestic manufacturers will benefit from a more transparent regulatory system and a single centralized authority, which should increase the efficiency of regulatory compliance; Regulations on pesticide package disposal will be drafted by MEP，MOA and the financial department under the State Council; On 1  April 2017, Chinese  Prime Minister Li Keqiang issued  State Council Decree 677 promulgating the revised pesticide regulation, “Regulation for the control of Agrochemicals（aka: Regulation on Pesticide Administration）”, which will take effect on 1 June 2017. The move is part of an overall regulatory/legislative/administrative reform in China…

Apr. 17th, 2017

Biocidal Product Authorization Consortia for Calcium Hypochlorite

Recently, the EU Biocidal Products Committee had issued that the active chlorine released from Calcium hypochlorite have been officially approved on December 14, 2016. The details of the active substance as below: Common name: Active chlorine released from Calcium hypochlorite Chemical name of the releaser: Calcium hypochlorite EC No. of the releaser: 231-908-7 CAS No. of the releaser: 7778-54-3 According to the Biocidal Products Regulation (BPR, Regulation (EU)528/2012), those companies whose active substance is Calcium hypochlorite in their biocidal products shall submit applications for biocidal product authorization no later than the date of approval of Calcium hypochlorite. Otherwise, the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of Calcium hypochlorite. Since the Calcium hypochlorite has been approved in December 14, 2016, the deadline of submit the product authorization dossier is the end of 2018 which is less…

Mar. 10th, 2017
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