Responsible agriculture FAQ

Responsible agriculture

Regulation and registration

How are crop protection products approved for sale?

The crop protection industry is one of the most highly regulated in the world, with products subject to extensive evaluation before they are approved for registration and sale. To register a product we must first demonstrate that it meets the regulatory standards of the country, that it can be used safely by workers, and that it has no adverse effects for the environment and the crops that it will protect, and to the food that will ultimately be produced from those crops. The exact nature of the study process depends on the planned use of the product – but generally more than a hundred studies covering toxicology, metabolism, residues, ecotoxicology, physical-chemical properties and environmental impact are performed.

The studies required for approval are performed in accordance with internationally agreed test guidelines which can take up to five years to complete. Once submitted for approval, the regulatory authorities evaluate the data over a two to four year period before reaching a conclusion on whether or not the product meets the country's regulatory standards. Authorization to sell is documented with a "registration certificate" issued by the regulatory authority. Registrations are usually time-limited and re-registration will be required after a certain period of time, often 10 years after the first registration.

On average, the development of any new crop protection product takes eight to 10 years and costs around $286 million before a product is commercially launched.

Does regulation of crop protection products differ between markets/countries?

The data requirements for approval of crop protection products are broadly similar in most countries. However, the way that the data are used and the conclusions reached by the regulatory authorities in product evaluations can differ depending on how countries have chosen to define protection goals.

In the US, the regulatory system considers the risks that crop protection products pose under realistic agricultural conditions. This approach focuses on factors such as the quantity of a substance that will actually be used by growers.

In Europe, a number of additional hazard-based regulatory cut-off criteria have been introduced - meaning that active ingredients will not be eligible for approval if classified as, for example, a carcinogen, a mutagen or a reprotoxin. These cut-off criteria apply regardless of the use rates of a crop protection product or whether there is any real risk for undesirable effects in practice. In Europe, all our crop protection products comply with relevant EEC Council directives and the EC's regulations on food safety.

What is a PIC listing and are any Syngenta products listed?

The Rotterdam Convention on the Prior Informed Consent Procedure is a global treaty that came into force in February 2004 and which is jointly implemented by the United Nations Environment Program (UNEP) and the Food and Agriculture Organization (FAO). The PIC procedure is designed to promote shared responsibilities in relation to international trade of certain hazardous chemicals and pesticides. The PIC listing process does not involve an evaluation whether products can be manufactured and used safely. Also, PIC does not constitute a ban or prohibition of affected products by FAO/UNEP or a recommendation by these organizations to do so.

No Syngenta active ingredient or formulation is currently listed in Annex III of the Rotterdam Convention on the Prior Informed Consent Procedure (PIC list).

Is Paraquat PIC listed?

No. Certain liquid formulations containing paraquat ion at or greater than 200 g/L were recommended for PIC listing as “Severely Hazardous Pesticide Formulations (SHPF)” by the Chemical Review Committee of the Rotterdam Convention upon a proposal from Burkina Faso. The Conference of the Parties to the Convention could not reach consensus in 2013 and 2015, and deferred further discussion to the next meeting in 2017. It is Syngenta’s view that Burkina Faso’s listing proposal does not demonstrate that these formulations meet the definition of a SHPF under the provisions of the Convention. Burkina Faso’s underlying study on pesticide poisonings provides no evidence of severe health incidents involving the product under conditions of use. Paraquat is used safely around the world, popular with farmers and a vital tool for sustainable agriculture.

What is Syngenta's view on bees and neonicotinoids?

Over the last 10–15 years there has been a global debate about honeybee populations, and the short and long term effects of pesticides, and specifically neonicotinoids on them. Over time, many other influence factors over bee populations have been studied by scientists, including: diseases caused by viruses, parasites, and mites; poor nutrition; climate change; lack of genetic diversity and lineage; stress brought on by frequent transport of honey bee colonies; poor beekeeping management; and combinations of these factors.

More than one third of the world's crops depend on pollination, which means our business is reliant upon the pollination provided by bees and other pollinators. We conduct constant research on the environmental effects of our products, while helping beekeepers and farmers to maintain suitable areas for bee forage and beekeeping coexistence. Our Operation Pollinator program has helped boost the number of pollinating insects near farmland. It provides farmers with locally suited flower seed mixes and best practice advice to enable them to create bee friendly areas in field.

In March 2013 we launched a new action plan in partnership with Bayer CropScience that looks to identify the reasons behind the variation in bee populations across the EU. Through the action plan we reiterate our commitment to creating pollen rich field margins, establishing field monitoring programs that measure bee health, implementing measures to mitigate the exposure risk to bees, investment in new technologies that reduce exposure risks during the planting of treated seeds, and further investment into the main factors impacting bee health, such as parasites and viruses.

How are GM seeds products approved for sale?

All genetically modified (GM) seeds products are subject to intense regulatory scrutiny. We follow international guidance for assessing the safety of our GM seeds products. Our regulatory experts around the world stay in regular dialogue with relevant regulatory authorities.

New GM seeds products only reach the market after the rigorous and comprehensive safety assessments of their environmental, feed and food safety have been reviewed and approved by the appropriate regulatory authorities.

Does regulation of GM seeds products differ between markets/countries?

New GM seed products are only placed on the market after the safety assessments have been reviewed and approved by the appropriate regulatory authorities in that particular county. The general type of data required for obtaining approvals is similar in various countries.

The time between submission to regulatory authorities and approval does vary by country. Government regulations, regulatory systems, and the politics that influence them, can vary widely and are subject to change. Obtaining product approvals can be time consuming and costly, and data requirements for approvals continue to increase. In some countries, approvals are time-limited and must be renewed periodically to ensure that each product continues to meet regulatory standards.

How does Syngenta ensure regulatory compliance of GM products?

We maintain high levels of stewardship for all our genetic modified (GM) products, helping us ensure compliance with regulatory standards. The processes we have in place are audited by the Excellence Through Stewardship (ETS) initiative – the first industry coordinated initiative that promotes the global adoption of stewardship programs and quality management systems across the full life cycle of biotechnology derived plant products.

Our focus on safety and the environment begins at the start of our product lifecycle. We are committed to complying with plant biotechnology regulations and we maintain a management system for handling our genetically modified crops that is modeled on ISO 9001, the international quality standard.

Our regulatory compliance team works globally to ensure compliance best practices are shared and comprehensive compliance programs are available where needed. This approach, combined with the experience, knowledge and risk awareness of our employees, ensures that we maintain a high level of compliance.

We report on our biotechnology regulatory compliance in our
Annual Review (p. 60).

What is the main challenge for the export trade of GM seed products?

As the export trade for major crops increases, one of the major challenges facing the industry is the harmonization of approval processes between major cultivation and importing countries. Approvals of genetically modified (GM) seed products occur at different times due to differences in country regulatory processes. Creating greater synergy between approval processes would facilitate trade and ensure choice of supply. We strongly uphold the right of growers to have access to approved new technologies that can increase both their productivity and crop yields. Read more on www.vipterafacts.com.

Several governments have signed a declaration of intent to work collaboratively on the issue of Low Level Presence of GM products where they have been approved in the country of origin but not in the countries of import – their aim is to facilitate improved international trade of agriculture commodities.

Does Syngenta support the development and improvement of national legislation and regulation with respect to the approval of phytosanitary products and seeds?

National regulatory authorities sometimes ask for public participation to develop or refine regulation with regard to biosafety aspects or phytosanitary questions.

Syngenta complies with regulatory requirements and has long experience of evaluating the safe use of our products. We are open to share our knowledge and to engage in dialogue with local regulatory authorities to help shape the regulatory framework.

We also support the development and improvement of regulatory systems by participating in initiatives and platforms bringing together industry organizations and regulatory authorities. Our staff is closely involved in the ‘Principles of Regulation’ Regulation’ initiative from CropLife International which provides building blocks for new regulation and measures for continuous improvement of existing regulation.

How does Syngenta support farmers using GM seeds in complying with national legislation and international conventions such as the Cartagena Protocol on Biosafety?

Syngenta contributes to the work of the Cartagena Protocol on Biosafety through the Global Industry Coalition (GIC). GIC was established during the negotiations on the Cartagena Protocol on Biosafety to provide concrete, reliable and accurate information for countries involved.

Syngenta strives to fully comply with the framework of existing national legislations and we are in an ongoing dialogue with regulatory authorities as our products move through the product life cycle. Commercial regulatory approvals of GM products often include post-launch regulatory obligations for the technology developer and their customers, as for example Insect Resistance Management practices.

Syngenta customers learn about these requirements through our comprehensive education programs that include the use of websites, face to face meetings, direct mailings, and product labeling. This education material often includes customer support contact information in the event the customer has a question related to stewardship requirements. Syngenta also partners with key external stakeholder groups such as industry associations and local farm groups to help deliver the messages to customers. Syngenta has also developed innovative solutions to enable our customer’s to more easily comply with the requirements. As an example, the integration of refuge seed into the bags of our insect-protected GM products helps growers to fulfill the refuge planting obligation.

Read more about the stewardship measures of our industry

Product safe use and stewardship

What does Syngenta do to make sure its products are used safely?

We are committed to the responsible and ethical management of our products throughout their life-cycle; we call this stewardship. Ensuring that our products are used safely is our priority. In The Good Growth Plan ,we have committed to train 20 million farm workers on labor safety by 2020.

In developed markets, industry authorities often provide training and guidance to users. In countries where this guidance does not exist, we train growers to handle products safely. In some areas low levels of literacy and little access to training can make it difficult to correctly read product labels or directions for use. Face-to-face training is complemented by safety messages on crop protection products through a variety of media including picture based training, actor-led dramas, and even TV and radio programs. We also provide specialist information to growers through our online platform “Pesticidewise”.

We monitor the response of growers to different safety messages, including the effectiveness of our training programs, in order to ensure that these important messages are understood by those who need them.
More information on this topic is also available in our
Annual Review (p. 19) and the Syngenta contribution to sustainable agriculture brochure.

What type of toxicovigilance support does Syngenta provide?

Syngenta has established toxicovigilance programs in 100 countries globally. These programs include agreements with poison centers or hospitals to offer a 24 hours, seven days a week medical information support for patients who were exposed to pesticide products.

The information collected from reported incidents feeds a database that serves to improve our pro-active stewardship programs and provides information to include in our dossiers for regulatory submissions. In addition, we frequently train physicians to improve medical treatments in the case of pesticide-related incidents.

Read more in our Annual Review (p. 55)

What stewardship measures does Syngenta adhere to regarding genetic modification?

We are committed to promoting full and effective stewardship from discovery to commercialization for all our plant genetically modified (GM) products to maximize the benefits and minimize any risk from using them. We believe that the appropriate management and use of our products is an important element underpinning sustainable agriculture and safeguarding the environment and public health.  

Our plant biotechnology stewardship lifecycle starts with gene discovery, includes plant development, seed production, seed marketing and distribution, crop production and crop utilization, and ends with product phase-out. We have worked with others in the agricultural biotechnology industry to develop and maintain the following stewardship programs to promote responsible management of plant biotechnology:

  • Insect and Weed Resistance Management

  • Field Trial Compliance Manual/Workshops

  • Containment Analysis and Critical Control Point (CACCP) Plan

  • Product Launch Stewardship Policy

  • Excellence Through Stewardship

Read more about our commitment to Biotechnology Stewardship

What is Syngenta doing to inform the public about the benefits of genetic modification?

We provide information on genetically modified (GM) technology and the benefits it can bring through open dialogue. We work with industry partners such as Crop Life International and the Council for Biotechnology Information to provide accurate and impartial information on the safety and benefits of GM technology. Other organizations that also provide information include the International Service for the Acquisition of Agri-Biotech Applications and the Biotechnology Industry Organization.

A good source of accurate information is GMO Answers, where people can ask questions to experts.

Resource efficiency and biodiversity

How does Syngenta contribute to improve resource efficiency?

We are committed to helping farmers around the world grow more and better quality food while using fewer natural resources. This means adopting sustainable farming practices that are more resource efficient and developing solutions that help farmers grow more from less.

Sustainably increasing farm productivity will add value to rural economies and make sure that land fertility is maintained and improved. Our best management practices are designed to provide farmers with simple, practical measures that enable them to work more productively and sustainably with the resources they have. Working closely with growers and stakeholders, we have developed simple measures that enable farmers to identify the issues and associated risks specific to their operation.

Read more about how we make crops more efficient and report on progress in The Good Growth Plan

How does Syngenta help to protect biodiversity?

Farming relies on biodiversity – it is crucial for crop pollination, healthy soils and water purification. At the same time, farming, and increased cultivation, can also have impacts on biodiversity. In The Good Growth Plan, we have committed to help biodiversity flourish by enhancing biodiversity on 5 million hectares of farmland by 2020.

We support projects that demonstrate the importance of biodiversity and resource management in the production of high-quality and sustainable crops. We work with farmers to help them understand the importance of managing biodiversity on their farms. For instance, our
Operation Pollinator program aims to increase populations of bees and other pollinating insects through the planting of locally suited flower mixes within field margins.

Crop diversity is one of the world's least recognized but most valuable resources. The conservation of crop varieties is essential to meet future challenges, such as food supply and those associated with climate change. Many initiatives on a local, national or supra-national level aim at preserving the genepools for future use and research. We work with seed banks around the world to share and protect the genetic diversity of food crops and we are a member of the
Global Crop Diversity Trust - a foundation committed to conserving crop diversity for global food security.

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