Agrochemicals and Biorationals RegistrationsPlant protection product registration for the industry

Agrochemicals and Biorationals Registrations

Plant protection product registration for the industry

The worldwide increase in agricultural production relies on a number of synthetic compounds and

natural products to minimize the negative impact of pests, diseases and weeds on the economical

production of crops. These plant protection products or pesticides include all substances or mixtures of

substances which prevent, destroy and control harmful organisms, as well as substances used as

plant growth regulators or for the protection of stored products. Considering the enormous

application rate of plant protection products on a worldwide scale, along with the possibility that each

human being, whether as producer, user or consumer, may come into direct contact with these

substances, a detailed evaluation of all possible impacts on humans, animals, plants and the

environment is required and supervised by relevant and wide-reaching directives and regulations. For

example, the competent bodies of the EU have evaluated over 1100 existing substances along with

newly developed substances according to Directive 91/414/EEC and Regulation 1107/2009, to

determine their acceptability for their use in plant protection product formulations. Accordingly, only

those substances which have minimal risk to man, animal and the environment have been added to

Annex I of Directive 91/414/EEC or are approved active substances according to Regulation 1107/2009

and are allowed to be used in formulations for use in the EU.

In replacing Directive 91/414/EEC, Regulation 1107/2009 implemented new developments concerning

the safety and the sustainable use of plant protection products. The new regulation not only contains

several improvements for users and producers of pesticides with respect to the application,

development and marketing of these products but also introduced the active substance types of

basic substances and low risk substances.

Basic substances, low risk active substances

Article 23 of Regulation 1107/2009 refers to the approval criteria for so called basic substances and

ANNEX II of Regulation 1107/2009 refers to the criteria applicable for so called low risk active

substances. These two special types of active substances do not exclusively apply only for biological

active substances but may also cover chemical or mineral active substances but a multitude of

biorationals may fulfil the criteria of these active substance types.

Guidance for the approval of basic substances is given by SANCO/10363/2012 rev.9 of 21 March 2014 -

WORKING DOCUMENT on the procedure for application of basic substances to be approved in

compliance with Article 23 of Regulation (EC) No 1107/2009.

Further specific guidance for the approval of low risk active is currently under development but the

criteria for approval of low risk substances were already adapted and amended by REGULATION

2017/1432 (COMMISSION REGULATION (EU) 2017/1432 of 7 August 2017 amending Regulation (EC) No

1107/2009 of the European Parliament and the Council concerning the placing of plant protection

products on the market as regards the criteria for the approval of low-risk active substances). According

to the Regulation an active substance other than a microorganism cannot be of low risk if the

substance is carcinogenic category 1A, 1B or 2, mutagenic category 1A, 1B or 2, toxic to reproduction

category 1A, 1B or 2, skin sensitiser category 1, serious damage to eye category 1, respiratory sensitiser

category 1, acute toxicity category 1, 2 or 3, specific Target Organ Toxicant category 1 or 2, toxic to

aquatic life of acute and chronic category 1, explosive, skin corrosive category 1A, 1B or 1C if the

substance has been identified as priority substance under Directive 2000/60/EC, if the substance is

deemed to be an endocrine disruptor, if the substance has neurotoxic or immunotoxic effects, is

persistent (half-life in soil is more than 60 days) or has a bio-concentration factor higher than 100.

Naturally occurring active substances may be considered as being low risk, even if half-life in soil is

more than 60 days or the bio-concentration factor is higher than 100. Furthermore, active substances

emitted and used by plants, animals and other organisms for communication, are to be considered as

low risk Microorganisms may be considered low risk unless, at strain level, multiple resistance to anti-

microbials used in human or veterinary medicine was shown; baculoviruses are considered low risk

unless the strain shows adverse effects on non-target insects.

In addition, low risk specific EPPO guidance on the principles of efficacy evaluation for low-risk plant

protection products was published in October 2017 (PP 1/296 (1)). “The objective of this document is to

provide a framework for the minimum efficacy data requirements needed to demonstrate that a low-

risk plant protection product is sufficiently effective (and crop safe) for authorization”. In general the

guidance allows for a scientific approach and justifications based e.g. on the Mode of Action (MoA) to

extrapolate between different crops and pests, or these of worst case circumstances regarding product

performance to extrapolate to less critical circumstances. Furthermore, the guideline states, that for

efficacy testing, GEP should be followed but that “non-GEP studies may be acceptable if scientifically

sound and in line with other applicable EPPO Standards”. Thus, valid data from other sources such as

publications, laboratory studies, etc. can also be used, at least as supplementary data. For low risk

products, the importance regarding the contribution to sustainable agriculture including compatibility

and function within an IPM programmes or with Organic Farming is highlighted in the respective

guidance and the benefits of the substance are to be is to be considered and described in the

application for authorisation of low risk products. In general, there is less data required compared to

conventional products. For example dose justification trials may not be necessary or are even

considered not a valid concept, for example in case of microorganisms that are capable of reproducing.

Ther minimum number of direct efficacy trials in an area of similar conditions is also reduced

compared to conventional plant protection products. For a major pest (group) on major a field crop

(group) 6 trials are foreseen. For a major pest under protected conditions 4 trials and for other uses 3

valid trials may suffice. Regarding phytotoxicity, trials are only required for plant growth regulators and

specific herbicides if adverse effects are observed in effectiveness trials. For other products (e.g. with

fungicidal or insecticidal activity) phytotoxicity can usually be addressed in effectiveness trials only

according to this guidance. Furthermore, the principles given in EPPO Standard PP 1/257 on efficacy

and crop safety extrapolations for minor uses may also be applied for major uses according to the new

EPPO standard PP 1/296 (1). PP 1/296 (1).

Integrated pest management and biological pest control

According to the recital of REGULATION (EC) No 1107/2009 OF THE EUROPEAN PARLIAMENT AND OF

THE COUNCIL of 21 October 2009 concerning the placing of plant protection products on the market

and repealing Council Directives 79/117/EEC and 91/414/EEC “to ensure a high level of protection of

human and animal health and the environment, plant protection products should be used properly, in

accordance with their authorisation, having regard to the principles of integrated pest management

and giving priority to non-chemical and natural alternatives wherever possible”. In addition to

Regulation 1107/2009 and DIRECTIVE 2009/128/EC OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL of 21 October 2009 establishing a framework for Community action to achieve the sustainable

use of pesticides, a thematic strategy on the sustainable use of pesticides was adopted in the European

Union.

As biological pest control is thus of increasing importance due to the obligatory implementation of

‘Integrated Pest Management’ and ‘National Action Plans’ in the EU by Directive 2009/128, these

aspects are also considered during preparation, submission and defence of dossiers for new and

existing biological active substances and products. Importance of biocontrol, IPM, precision farming,

organic farming and sustainability and the necessity to consider these in the data requirements for

active substances and plant protection products is highlighted for example by various recent EU

Parliament Resolutions such as P8_TA-PROV(2019)0082: European Parliament resolution of 12 February

2019 on the implementation of Directive 2009/128/EC on the sustainable use of pesticides

(2017/2284(INI)) or P8_TA(2017)0042: European Parliament resolution of 15 February 2017 on low-risk

pesticides of biological origin (2016/2903(RSP)).

Microorganisms

According to the nature of the active substance different guidance and guidelines apply. For

microorganisms the taxonomic level of the specific microorganism strain has to be considered.

Guidance is provided by Sanco/10754/2005, rev.5 of 15 April 2005 - Guideline developed within the

Standing Committee on the Food Chain and Animal Health on the taxonomic level of microorganisms

to be included in Annex I to Directive 91/414/EEC. Other aspects for micro-organism active substance

approval are SANCO/12116/2012, rev. 0 of September 2012, a Working Document on

Microbial Contaminant Limits for Microbial Pest Control Products or SANCO/12823/2012 rev. 4 of 12

December 2014 which is the valid GUIDANCE DOCUMENT FOR THE ASSESSMENT OF THE EQUIVALENCE

OF TECHNICAL GRADE ACTIVE INGREDIENTS FOR IDENTICAL MICROBIAL STRAINS OR ISOLATES

APPROVED UNDER REGULATION (EC) No 1107/2009. Details on the Environmental Safety Evaluation for

microorganisms are given in SANCO/12117/2012 rev. 0 of September 2012 Working Document to the

Environmental Safety Evaluation of Microbial Biocontrol Agents. In addition to the specific guidance

and guidelines on the safety of active substances of plant protection products human safety aspects for

biological agents are addressed by DIRECTIVE 2000/54/EC OF THE EUROPEAN PARLIAMENT AND OF

THE COUNCIL of 18 September 2000 on the protection of workers from risks related to exposure to

biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive

89/391/EEC). Overall guidance for preparation of micro-organism active substance dossiers is provided

by SANCO/12545/2014 rev. 1 - GUIDANCE DOCUMENT FOR APPLICANTS ON PREPARING DOSSIERS FOR

THE APPROVAL OR RENEWAL OF APPROVAL OF A MICROORGANISM INCLUDING VIRUSES ACCORDING TO

REGULATION (EU) No 283/2013 AND REGULATION (EU) No 284/2013. Further guidance for specific

microorganisms is provided for baculoviruses by SANCO/0253/2008 rev. 2 of 22 January 2008 -

Guidance Document on the assessment of new isolates of baculovirus species already included in

Annex I of Council Directive 91/414/EEC.

Botanicals

Another type of biological active substances are botanicals. Guidance for approval of

botanical active substances is given by SANCO/11470/2012– rev. 8 of 20 March 2014 - GUIDANCE

DOCUMENT ON BOTANICAL ACTIVE SUBSTANCES USED IN PLANT PROTECTION PRODUCTS.

Semiochemicals

In addition to the guidance documents for the approval of biological active substances mentioned

above, for two other types of biopetsicides specific guidance is available. For one,

Straight Chain Lepidopteran Pheromones are regulated by SANCO/5272/2009 rev. 4 1 of February

2013, the Guidance Document on the assessment of new substances falling into the group of Straight

Chain Lepidopteran Pheromones (SCLPs) included in Annex I of Council Directive 91/414/EEC and

further guidance on semiochemicals is given by SANTE/12815/2014 Rev. 4.1 of June 2015 Guidance

Document on Semiochemical Active Substances used in Plant Protection Products.

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biorationals) for more information about available services.

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