Conclusion and decision on the approval of metalaxyl-M   Applications for amendments to the approval of active substances in GB are regulated under assimilated Regulation No 1107/2009.   Applicant   Syngenta UK Limited   Substance   Metalaxyl-M – a fungicidal active substance for the control of various fungal diseases in sugar beet and vining peas (both outdoor and protected).   Conclusion   HSE’s Conclusion of Authority was published on 31 October 2024.   HSE concluded that metalaxyl-M meets the approval criteria with:   The restriction 'when used for seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised' removed   A previously relevant impurity no longer considered as being toxicologically or ecotoxicologically relevant   The groundwater metabolite NOA409045 no longer considered a relevant groundwater metabolite   The risk assessment which underpins the conclusion has been subject to public consultation.   View the published Conclusion of Authority linked in the active substances amendments spreadsheet on the HSE website.   HSE referred its conclusion and proposed decision to GB competent authorities, as required under the Agency Agreements between HSE and the individual devolved governments.   Decision   GB competent authorities awarded consent for HSE to take the amendment decision. Metalaxyl-M can remain approved as a pesticide active substance in GB, for use in PPPs, with the following amendments:   Removal of the restriction ‘when used as a seed treatment, only the treatment of seeds intended to be sown in greenhouses may be authorised’ as a safe use of treated seed sown outdoors was demonstrated   Removal of a previously relevant impurity as it is no longer considered as being of toxicological or ecotoxicological relevance   Reclassification of the groundwater metabolite NOA409045 as it is no longer considered a relevant metabolite   The approval conditions of metalaxyl-M have now been updated, and the decision document added to the GB Pesticides Approvals Register on the HSE website.   PPPs containing metalaxyl-M can be authorised in GB, in accordance with the requirements of assimilated Regulation No 1107/2009. Incorporation of the metalaxyl-M approval amendments into PPP authorisations will require further assessment by HSE.   From Agropages, https://news.agropages.com/News/NewsDetail---52377.htm

The European Commission has decided to withdraw the marketing authorization for the fungicide fenpyrazamine earlier than planned: from 15 January 2025, its use will no longer be permitted in the European Union.   Fenpyrazamine is a fungicide that has preventive, curative, and antisporulant action on Botrytis sp., Monilia sp., and Sclerotinia sp., among other pathogens. The authorization of this substance used mainly to treat cherry, strawberry, and peach trees, had been extended until 31 May 2026, pending the remaining stages of the approval renewal procedure. However, the applicant company confirmed its intention not to support this application.   The Commission noted, ″The extension of the approval period for this substance is no longer justified″ and, therefore, ″it is appropriate to set a new expiry date as soon as possible, leaving Member States sufficient time to withdraw their authorizations for plant protection products containing this active substance.″ It has thus shortened the authorization period until 15 January.   From Agropages, https://news.agropages.com/News/NewsDetail---52302.htm

Dec. 2, the U.S. Environmental Protection Agency announced a proposed rule to revoke tolerances for chlorpyrifos, which establish the amount of a pesticide that is allowed on food. This rule revokes all tolerances for chlorpyrifos, except for those tolerances associated with the 11 food and feed crops that remain registered. EPA is taking this action in response to a decision by the U.S Court of Appeals for the Eighth Circuit. This action will support EPA efforts to cancel most uses of chlorpyrifos on food to reduce exposure and protect public health.   ″EPA continues to prioritize the health of children,″ said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. ″This proposed rule is a critical step forward as we work to reduce chlorpyrifos in or on food and to better protect people, including infants and children, from exposure to chemicals that are harmful to human health.″   Chlorpyrifos is an organophosphate (OP) insecticide that was used for a large variety of agricultural uses, including soybeans, fruit and nut trees, vegetables, and other row crops, as well as non-food uses. At high levels, OP exposures can result in neurological effects such as tremors, fatigue and nausea. There is also concern for exposures to pregnant women and children since chlorpyrifos has been associated with neurodevelopmental effects indicating it could impact the normal development of the nervous system during pregnancy or childhood.   In a final rule issued in August 2021, EPA revoked all tolerances for chlorpyrifos, which establish an amount of chlorpyrifos that is allowed on food, effectively stopping the use of chlorpyrifos on all food and animal feed. EPA took this action in response to an April 2021 order from the U.S. Court of Appeals for the Ninth Circuit for the agency to issue—within 60 days—a final rule addressing the use of chlorpyrifos in food or feed crops, without taking public comment or engaging in ″further fact-finding.″   On Nov. 2, 2023, the U.S. Court of Appeals for the Eighth Circuit vacated EPA’s August 2021 rule and reinstated the chlorpyrifos tolerances. On Feb. 5, 2024, EPA issued a Federal Register notice to amend the Code of Federal Regulations to reflect the court’s reinstatement of those tolerances. At this time, and as a result of the court decision, all the chlorpyrifos tolerances have been reinstated and are currently in effect.   Since the Eighth Circuit issued its ruling, EPA has worked with the chlorpyrifos registrants to further reduce pesticide exposures by limiting the registered uses of chlorpyrifos on food to be consistent with the 11 uses referenced by the Eighth Circuit and identified in the 2020 Proposed Interim Registration Review Decision (PID). These 11 food uses are alfalfa, apple, asparagus, cherry (tart), citrus, cotton, peach, soybean, strawberry, sugar beets and wheat (spring and winter) and are limited to specific states that were assessed in the 2020 PID. Based on the available data, retaining only the 11 food uses could decrease average annual pounds of chlorpyrifos applied in the U.S. by 70% as compared to historical usage.   The registration review process for chlorpyrifos is ongoing. EPA plans to issue an amended PID for chlorpyrifos for public comment followed by an Interim Decision (ID) in 2026.   Upon publication in the Federal Register, the proposed rule will be available at docket ID EPA-HQ-OPP-2024-0431 at Regulations.gov for public comment for 60 days. EPA will continue to keep the public updated as it evaluates and takes any actions related to chlorpyrifos pesticide use. For more information, view a prepublication version of the Federal Register notice.   Learn more about this pesticide at EPA’s chlorpyrifos webpage.   From Agropages,https://news.agropages.com/News/NewsDetail---52253.htm

The ban on the fungicide carbendazim in Brazil was blocked through a favorable decision in the Brazilian Parliament. The Committee on Agriculture, Livestock, Supply and Rural Development of the Brazilian Chamber of Deputies approved a legislative decree project (PDL 312/22) that nullifies a resolution (RDC 739/22) against the fungicide carbendazim formulated by the National Health Surveillance Agency (Anvisa).   Authored by Representative José Mário Schreiner, legislative decree 312/22 argues that Anvisa's decision was taken "abruptly, without considering the economic and productive impact on the agricultural sector." The project text highlights that carbendazim has been used in Brazil for more than 30 years, with registrations since 1991. It points out that its withdrawal from the market generates negative consequences, such as economic losses and possible environmental liabilities due to inadequate disposal of stored products.   The PDL emphasizes that the active ingredient is widely used in more than 80 countries and states that there is no global scientific consensus justifying its prohibition. Additionally, the document draws attention to the essentiality of carbendazim for disease control in crops such as beans and rice.   According to the text attached to the project, at the time of Anvisa's suspension, the Brazilian market had more than 1.6 million liters of formulated products ready for commercialization and large quantities awaiting import and distribution. The revocation of the ban aims to ensure the continuity of the production chain and avoid increases in food costs.   The PDL's rapporteur, Representative Marussa Boldrin, defended the approval stating that Anvisa's decision was made without robust technical studies and without a detailed analysis of economic impact. She emphasized that interrupting the use of carbendazim could compromise Brazilian agribusiness competitiveness, in addition to causing significant increases in food prices.   "Abruptly suspending the import, production, and commercialization of carbendazim, without an adequate substitution plan, could generate serious disruptions in the agricultural supply chain," stated Boldrin.   She also argued that Law 9,782/99, which created Anvisa, requires that such decisions be based on technical studies of economic impact and solid scientific analyses. The project will still be analyzed by the Social Security and Family Committee and the Constitution, Justice, and Citizenship Committee. Afterward, it proceeds to the plenary of the Brazilian Chamber of Deputies.   From Agropages, https://news.agropages.com/News/NewsDetail---52197.htm

New common name provisionally approved for a nicotinamide insecticide from Syngenta Crop Protection.   IUPAC PIN: 4-(trifluoromethyl)pyridine-3-carboxamide IUPAC NAME: 4-(trifluoromethyl)pyridine-3-carboxamide CAS NAME: 4-(trifluoromethyl)-3-pyridinecarboxamide CAS REG. NO.: 158062-71-6 FORMULA: C7H5F3N2O ACTIVITY: insecticides (nicotinamide) INCHIKEY: JUIWZYBJXUPIKF-UHFFFAOYSA-N INCHI: InChI=1S/C7H5F3N2O/c8-7(9,10)5-1-2-12-3-4(5)6(11)13/h1-3H,(H2,11,13)   Please contact the Maintenance Agency no later then 5th December 2024 for any objections (for example, the name ″flumetnicam″ infringes on any trademarks). If no objections are received, then the name ″flumetnicam″ will become approved and will be included in the March 2025 update of the XML data set that is available to everyone who purchases ISO 1750:2023.   From Agropages, https://news.agropages.com/News/NewsDetail---50397.htm

Single application to extend patent protection of medicinal and plant protection products for five years EU certificate to ensure protection across EU patent system and cut red tape and costs related to independent national certificates MEPs want clear, more transparent and time-efficient procedures on applications, appeals, oppositions and remedies administered by EUIPO   MEPs adopt their first reading position about EU supplementary certificates enabling longer protection of patented medicinal and plant protection products.   Innovative medicines and pesticides should enjoy 5-year longer EU-wide patent protection on top of 20-year protection of patent to compensate for lengthy testing requirements before these products are placed on the EU market. Unitary supplementary protection certificates aim to cover costs invested into research of innovative substances at the EU level.   Single procedure   The unitary character of certificate should ensure that EU patent holders do not have to apply for extended protection in each member states separately, but can save costs and time by applying for an EU certificate at the European Union Intellectual Property Office (EUIPO) and it would be applicable equally in all countries that have joint the EU patent system. Combined application would allow them to ensure protection of their patents at the national level in those EU countries, which have not joined the EU patent system. MEPs want the centralised application to be examined by one EUIPO member and two examiners from national patent offices with sufficient expertise and experience, who would be able to grant the certificate or refuse the application.   Easier procedure for plant protection products   Plant protection products can only be placed on the EU market with valid marketing authorisation and these are provided nationally at different times. MEPs thus want manufacturers of innovative plant protection products to be able to apply for EU certificate as soon as a marketing authorisation was granted in at least one EU country, which is part of the common patent system. MEPs also suggest the possibility of centralised authorisation procedure for plant protection products. They want the Commission to assess after five years whether such a procedure under the European Food Safety Authority would not be necessary and appropriate.   Electronic process for medicinal products   Manufacturers of innovative medicinal products already enjoy centralised procedure for obtaining marketing authorisations. It will therefore become basis for application for unitary protection certificate. MEPs want the manufacturers to be transparent in the process about public financial support received for development of their patented products. Given the importance of innovative medicines and vaccines in crises in particular, MEPs foresee the need for expedited examinations of medicinal products in some situations which should last four instead of the usual six months.MEPs also want certificate application and related exchanges on appeal to be electronic while the format of submissions should be provided by EUIPO.   Quote   Following the plenary vote, rapporteur Tiemo Wölken (S&D, DE) said: "The new rules will benefit Europeans Industry by reducing the cost and burden of obtaining or maintaining a supplementary protection certificate. Furthermore, thanks to the unitary nature we will remove the fragmentation that currently exists between Member States when it comes to the implementation of the regulatory framework and hence granting an SPC, providing predictability for both the innovative and generic industry."   Next steps   MEPs approved their position on unitary supplementary protection certificate for plant protection products with 516 votes in favour, 26 against and 74 abstentions and on supplementary protection certificate for plant protection products with 523 votes in favour, 26 against and 69 abstentions. European parliament position on unitary supplementary protection certificate for medicinal products was approved with 518 votes in favour, 29 against and 70 abstentions and on supplementary protection certificate for medicinal products with 526 votes in favour, 23 against and 70 abstentions.   Parliament is now ready to start talks with EU countries on the final shape of the legislation. The file will be followed up by the new Parliament after the European elections on 6-9 June.   Background   These proposals on revision, modernisation and introduction of a system for unitary supplementary protection certificates complement the unitary patent system, which is a major step towards the completion of the single market for patents. They were announced as part of the ‘EU patent package’ in 2023, which also includes a new initiative on compulsory licensing and legislation on standard-essential patents. From Agropages，https://news.agropages.com/News/NewsDetail---49378.htm

The Federal Government of Nigeria has approved the commercial release of transgenic insect-resistant and drought-tolerant maize varieties, known as TELA maize.   The approval was granted by the National Committee on Naming, Registration and Release of Crop Varieties, Livestock Breeds/Fisheries (NCNRRCVLF), headed by Prof Olusoji Olufajo at its 33rd meeting at the National Centre for Genetic Resources and Biotechnology (NACGRAB), Ibadan on January 11, 2024.   The four varieties approved by the NVRC are SAMMAZ 72T, SAMMAZ 73T, SAMMAZ 74T, and SAMMAZ 75T.   The new maize varieties are drought tolerant and are resistant to stem-borer and fall armyworms, resulting in a yield advantage of up to 10 tons per hectare under good agronomic practices. The national average for similar hybrids is six tons per hectare.   ‘Very proud of our scientists’   Stem borers reduce maize production in several countries in Africa. At the same time, fall armyworms can destroy up to 20 million metric tons of maize in Africa each year, enough to feed 100 million people.   The release and registration of the four varieties followed environmental release approval in October 2021, granted by the National Biosafety Management Agency (NBMA).   Development of the improved varieties was led by the Institute for Agricultural Research (IAR) Samaru, Ahmadu Bello University Zaria, through the TELA Maize Public-Private Partnership coordinated by AATF. The TELA Maize Project is being implemented in Ethiopia, Kenya, Mozambique, Nigeria, and South Africa.   Prof Ado Yusuf, Executive Director of IAR, expressed satisfaction with releasing the four new maize varieties, saying, ″IAR is very proud of our scientists who are addressing the maize productivity challenges in the country and beyond. These varieties have undergone thorough research and developed using biotechnology tools over several years of continuous testing and revalidation.″   Dr Canisius Kanangire, AATF’s Executive Director, said: ″The release of TELA Maize in Nigeria will contribute to food and nutrition security in line with the Federal Government’s Agricultural Transformation agenda. AATF reaffirms unwavering commitment to addressing challenges farmers face across the continent.″   Reduce the use of pesticides   Professor Garba Sharubutu, the Executive Secretary of the Agricultural Research Council of Nigeria (ARCN), said the approval of the TELA Maize variety in Nigeria is a critical milestone that confirms the potential of biotechnology in ensuring food and nutrition security and improved livelihood of farming households in Africa.   Prof Mustapha Abdullahi, Director-General of the National Biotechnology Development Agency (NABDA), celebrated the release, saying that, with the advent of TELA Maize, farmers will reduce the use of pesticides on maize to the bare minimum, which is beneficial to humans, livestock, and the environment.   Dr Sylvester Oikeh, the TELA Maize Project Manager, celebrated Nigeria’s decision by calling other African countries to act for farmers. ″I am encouraged by this decision by the Federal Government of Nigeria that reflects their commitment to the needs of farmers. I congratulate the scientists for their hard work and dedication that has seen the product getting closer to farmers. I look forward to other countries making similar decisions for the farmers’ good,″ Dr Oikeh said.   The other partners in the TELA Maize project are national agricultural research institutes in Kenya, Mozambique, Ethiopia, and South Africa; the International Maize and Wheat Improvement Center (CIMMYT) and Bayer, with funding from Bill and Melinda Gates Foundation and United States Agency for International Development (USAID).   From Agropages, https://news.agropages.com/News/NewsDetail---48855.htm

The Brazilian National Health Surveillance Agency (Anvisa) has opened a period for public comments on the pesticide Isopyrazam.    This fungicide is the active ingredient in various Syngenta products worldwide, including Rikali and Reflect. The outcome of this public consultation may determine the future of the product registration process in Brazil.   Isopyrazam belongs to the group of SDHIs (succinate dehydrogenase inhibitors), which targets complex II (or succinate dehydrogenase) in the mitochondrial respiratory chain, disrupting the flow of electrons and thus altering cellular respiration. SDHI group fungicides function by blocking a crucial step in fungal respiration provided by succinate dehydrogenase (SDH).   FRENCH ALERT   A team of French researchers argues that SDHI family fungicides are toxic not only to fungi but also to earthworms, bees, and human cells. Pierre Rustin, a researcher at Inserm (National Institute of Health and Medical Research) led the team, which also published a study in the scientific journal Plos One. In the research, they highlight the toxicity of eight SDHI family fungicides (Flutolanil, Fluopyram, Boscalid, Fluxapyroxad, Penflufen, Penthiopyrad, Isopyrazam, and Bixafen).   Those interested in supporting or contesting the market entry of the product can access the suggested draft and the form for consideration through the Anvisa website: http://antigo.anvisa.gov.br/consultas-publicas#/   From Agropages, https://news.agropages.com/News/NewsDetail---48588.htm