Regulation According to EU Directive 91/414: Data Requirements and Procedure Compared with Regulation Practice in Other OECD Countries

Hauschild, Rüdiger; Speiser, Bernhard; Tamm, Lucius

doi:10.1007/978-90-481-3664-3_2

Cited by 13 publications

(30 citation statements)

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“…Their extension into environmental safety assessments came in response to concerns related to the increasing number of reports of environmental damage due to pesticide toxicity and the accumulation of chemical residues such as those from DDT (Hauschild et al, 2011). Gradually, mounting public pressure and the implementation and enforcement of stricter rules and regulations led to the ban and rejection of many chemical pesticides and the need for lower-impact pesticides such as those classified as biological control agents (BCA) and microbial pest control agents (MPCA).…”

Section: Registration Of Baculovirusesmentioning

confidence: 99%

“…Since then, a trend has emerged that now favours the development of lower-risk products such as BCAs and MPCAs and specific regulations have been developed that are better suited to the requirements of MPCAs. To facilitate the registration process for MPCAs, many countries have established departmental branches that specialize in the registration of MPCAs and other low-risk product submissions (Hauschild et al, 2011;Kabaluk et al, 2010). Despite these efforts, the MPCA registration process in many countries still requires a number of toxicity tests that might not be necessary based on the biology of the microbe that acts as the active ingredient of a MPCA.…”

Section: Registration Of Baculovirusesmentioning

confidence: 99%

“…Although the registration procedures, costs and processing times differ between countries, data requirements are generally similar (Hauschild et al, 2011). Typically, numerous categories of data are required for the registration of MPCAs.…”

Section: Registration Of Baculovirusesmentioning

confidence: 99%

“…Typically, numerous categories of data are required for the registration of MPCAs. These categories are designed so that applicants provide 1) product identity, physical, chemical and technical properties; 2) methods of analysis, manufacturing and quality control; 3) toxicological studies and exposure data geared towards human and veterinary health and safety; 4) product residue data; 5) product fate and behaviour in the environment; 6) environmental and non-target toxicity and 7) efficacy data (Hauschild et al, 2011).…”

Section: Registration Of Baculovirusesmentioning

confidence: 99%

“…The regulations as applied to some of the more recently registered baculovirus-based products may, however, demonstrate the redundancy of certain data requirements involving vertebrate toxicity (categories 3 and 6) and some aspects of environmental and non-target effects (categories 4 and 5). The Pest Management Regulatory Agency (PMRA) in Canada and the United States Environmental Protection Agency (EPA) accept that certain data requirements can be met using "waivers" that provide scientific arguments based on published, peer-reviewed, scientific literature and data while, in the European Union (EU), less formal procedures allow for similar science-based evidence to replace the actual, newly-generated data (Hauschild et al, 2011). A combination of fulfilling specific data requirements and the use of waivers were used in the successful registration of the baculovirus-based product, Abietiv, for the suppression of balsam fir sawfly populations in Canada .…”

Section: Registration Of Baculovirusesmentioning

confidence: 99%

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Recent Advances in Our Knowledge of Baculovirus Molecular Biology and Its Relevance for the Registration of Baculovirus-Based Products for Insect Pest Population Control

Lapointe¹,

Thumbi²,

Lucarotti³

2012

Integrated Pest Management and Pest Control - Current and Future Tactics

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Section: Registration Of Baculovirusesmentioning

confidence: 99%

Section: Registration Of Baculovirusesmentioning

confidence: 99%

Section: Registration Of Baculovirusesmentioning

confidence: 99%

Section: Registration Of Baculovirusesmentioning

confidence: 99%

Section: Registration Of Baculovirusesmentioning

confidence: 99%

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Recent Advances in Our Knowledge of Baculovirus Molecular Biology and Its Relevance for the Registration of Baculovirus-Based Products for Insect Pest Population Control

Lapointe¹,

Thumbi²,

Lucarotti³

2012

Integrated Pest Management and Pest Control - Current and Future Tactics

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Basic substances: an opportunity for approval of low‐concern substances under EU pesticide regulation

Marchand

2015

Pest Management Science

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Plant extracts and byproducts furnish various alternative products for crop protection and are traditionally used by farmers. However, the cost and timeframe for their registration as active substances are prohibitive for small companies and farmers' associations with the new Plant Protection Products (PPP) Regulation (EC) No. 1107/2009. However, there is now a possibility of registering light compounds as 'basic substances', a new category described in Article 23 and in 'Whereas/Recital 18'. We developed a regulatory expertise on the approval of such products within the framework of the PPP regulation. A Draft Assessment Report in one volume was established, later transformed by EC Directorate into a Basic Substance Application Template, and subsequently used by the EC as a matrix for the corresponding Guidelines for applicants (SANCO 10363/2012 rev. 9). Here we provide further tools, consisting of methodological, linguistic and strategic recommendations in order to constitute a Basic Substance Application (BSA) and proceed to its registration. While the use of alternative agents for crop protection is increasing both in organic and conventional agriculture, these usages are still considered as 'minor uses'. Our approach and tools are valuable to non-PPP specialised applicants for simplifying and facilitating their submission of the BSA.

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Differences in the progress of the biopesticide revolution between the EU and other major crop‐growing regions

Balog

Hartel

Loxdale

et al. 2017

Pest Management Science

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BACKGROUND:The five year value in the compound annual growth rate of the biopesticides sector is predicted to be 16% by 2017 and to produce a global market worth This article is protected by copyright. All rights reserved.This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/ps.4596 Accepted Article$US 10 billion. Despite this, several impediments occur within the EU that negatively influencing biopesticide research and innovation.RESULTS: At present, there are fewer biopesticide-active substances registered in the EU compared to the USA, India, Brazil and China. The relatively low level of biopesticide research in the EU (6,880 ISI papers) versus the USA (18,839), India (9,501) and China (7,875) relates to the greater complexity of EU-based biopesticide regulations compared to these other countries. In this light, it is worth noting that tensions may exist between regulators that emphasise the beneficial nature of biopesticides in environmentally-friendly crop management, and those that adopt a more technologically-based approach dependent on a chemical pesticide-driven model. CONCLUSION:Compared to the other aforementioned countries, far fewer biopesticide products are available in the EU market, mainly as a direct result of the severe regulatory factors present there. The extent to which this trend will continue depends largely on a range of interacting political and/or regulatory decisions that influence environmentally-friendly agricultural industries.Keyword: Environmentally-friendly agriculture, political decisions, environmental laws, pesticide laws, biopesticide research IntroductionCrop production currently represents about 813.5 million tonnes worldwide 1 . Global changes, including extreme variations in climatic conditions, are highly likely to affect agricultural This article is protected by copyright. All rights reserved. Accepted Articleproduction, thereby representing a challenge for global food security 2 . Outbreaks of herbivorous insects and mites, plant diseases caused by plant pathogens (viruses, bacteria, phytoplasma and funguses) and weeds may become more frequent in the face of global change, representing a major impediment to crop production. However, as a result of the evolution of pesticide resistance in the last 50 years or so, many of these pests (including weeds and diseases) are difficult to control. The damage caused by insects and mites ranges from 8-23 % in the USA with an estimated loss of some 5-15% from the total of $US 200 billion in revenue each year [3][4][5] . Invasive pests represent new types of threats and challenges as global trade expands and the climatic conditions shift 6,3,4 . Recent estimates suggest that the losses of crop yield caused by invasive pests will increase to 25% in the EU by 2080 5 .The excessive use of chemic...

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Regulation According to EU Directive 91/414: Data Requirements and Procedure Compared with Regulation Practice in Other OECD Countries

Cited by 13 publications

References 0 publications

Recent Advances in Our Knowledge of Baculovirus Molecular Biology and Its Relevance for the Registration of Baculovirus-Based Products for Insect Pest Population Control

Recent Advances in Our Knowledge of Baculovirus Molecular Biology and Its Relevance for the Registration of Baculovirus-Based Products for Insect Pest Population Control

Basic substances: an opportunity for approval of low‐concern substances under EU pesticide regulation

Differences in the progress of the biopesticide revolution between the EU and other major crop‐growing regions

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