Home Agrochemicals and Biopesticides Registration

Agrochemicals and Biopesticides RegistrationPlant protection product registration for the industry

Agrochemicals Registration – Biopesticides RegistrationPlant 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 as 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. 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, 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 the Directive and are allowed to be used in formulations

for use in the EU.

Sustainable use of plant protection products

Regulation 1107/2009/EC replaced Directive 91/414/EEC in 2010, constituting an improved

development concerning the safety and the sustainable use of plant protection products. This new

regulation implies an improvement for users and producers of pesticides with respect to the

application, development and marketing of these products.

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

Download Information to'Agrochemicals and BiopesticidesRegistration'

Biocidal Products

More information about availableservices

More available services relating to

Agrochemicals and Biopesticides Registration

– visit the SCC Homepage

More info

www.bio-pesticides.eu/agrochemicals_biopesticides_registration.php

1 von 3

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 defense of dossiers for new and

existing biological active substances and products.

Microorganisms

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

organisms the taxonomic level of the specific micro-organism 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 micro-organisms 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 micro-

organisms 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 MICRO-ORGANISMS INCLUDING VIRUSES ACCORDING

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

micro-organisms 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.

2 von 3

Basic substances, low risk active substancesArticle 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

biopesticides may fulfill the criteria of these active substance types. Whereat 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. Specific guidance for the approval of low risk active is currently under

development in a DRAFT WORKING DOCUMENT FOR THE PURPOSE OF A POSSIBLE AMENDMENT OF

THE CURRENT LOW RISK CRITERIA.

Please refer to SCC's home page (http://www.scc-gmbh.de/business-units/agrochemicals-

biopesticides) for more information about available services.

The information regarding the topic "Agrochemicals and Biopesticides Registration" displayed on thiswebsite were provided by SCC.

During our more than 25-year history Scientific Consulting Company – SCC GmbH – has become one of Europe's largest privately-owned and independentconsulting companies supporting global customers in the regulatory affairs business.

SCC is located in Bad Kreuznach, Germany; an hour's drive west of Frankfurt am Main. Please refer to SCC's home page (http://www.scc-gmbh.de/business-units/agrochemicals-biopesticides) for more information about available services relating to Agrochemicals & Biopesticides.

Discover the world of SCC on our website: www.scc-gmbh.de

Contact us: Open Contact form or send us an email at scc@scc-gmbh.de

© SCC GmbH. All rights reserved. Imprint

3 von 3