EU Plant Protection Products Regulation (EU PPP)

Overview

EU Pesticide Regulation (EC) No 1107/2009（referred to as EU PPPs Regulation）lays down harmonized rules for the approval of active substances and the placing on the market of plant protection products in the European Union. It was published in 2009 to replace old Directive 91/414/EEC and was entered into effect on 14^th, June 2011.

To support the implementation of this Regulation, Regulation (EU) 283/2013 and Regulation (EU) 284/2013 are published stipulating the data requirements for the registration of pesticide active substances and pesticide formulation products (Plant Protection Products) in EU, respectively.

In addition to this, a series of guidance documents has been published by EC (European Commission), EFSA（European Food Safety Authority）and competent authorities of EU MSs (EU Member State) as supporting and supplemental to PPPs Regulation, elaborating on specific aspects of registration (for example, details regarding the registration process, review fees, data protection, risk assessment, etc.).

Statutory Bodies

There are 3 main Statutory Bodies in PPPs regulation. EFSA (European Food Safety Authority) and RMS (Rapporteur Member State) work closely on the evaluation of active substances and PPPs, while COM (European Commission) is a decision-maker organization.

Scope of EU PPPs Regulation

The PPP Regulation establishes a two-step system. In the first step, the active substance contained in a PPP is approved at the EU level, with at least one use with a formulated product is proved to be safe. In the second step, Member States authorize PPPs containing the active substance for specific uses, according to harmonized EU standards (the so-called uniform principles (EU) No 546/2011) and good agricultural practices (GAPs), with local agricultural and environmental/climatic differences considered.

Who can Register under the EU PPPs Regulation?

Pesticide manufacturers, traders, etc. in and outside the EU.

EU PPP Registration Process

Approval of Active Substance

Procedure of Approval/Renewal of Active Substance Under EU PPPs Regulation

Active substances are approved at Community level. For new active substances, the applicant can appoint the Rapporteur Member State (RMS), of their choice.

The RMS produces a report of their evaluation, called Draft Assessment Report (DAR) after detailed evaluation of the dossier by applicant. The DAR is then forwarded to the European Food Safety Authority (EFSA). EFSA is responsible for the peer review process of the active substance. EFSA, where appropriate shall organize a consultation of experts, including experts from the rapporteur Member State. EFSA is also required to provide a conclusion on the active substance.

Finally, a proposal for approval or non-approval of the active substance is prepared by the European Commission and forwarded to the Standing Committee on Pesticides, Animals, Food and Feed (SCoPAFF), attended by all Member States, to formally give an opinion (by qualified majority vote) on the proposal.

Therefore, once an active substance is approved, it will be accepted in all member state in EU, the source of which will become the reference source. In accordance with to the Regulation 1107, first approval shall be for a period not exceeding 10 years. If an active substance is approved as a low-risk substance, the approval period will be 15 years.

Before the expiration of the approval period of an active substance, it is necessary to start the renewal process in order to complete the evaluation before its expiration, realizing the smooth renewal of the approval period.

No later than 3 years before the expiration of the active substance approval, the application on renewal of the active substance shall be submitted, and the new evaluation process begins. Approved active substances are re-evaluated under the renewal programme (“AIR”). A Member State is appointed as a “rapporteur” (RMS) to carry out an initial risk assessment and to prepare a renewal assessment report (RAR), meantime a Member State may be appointed as Co-rapporteur (Co-RMS) to offer assistance. RAR is then peer reviewed by EFSA together with the Member States.

The process of renewal has a lot of similarities with the process for active substance approval.

Same as first approval, the duration period of renewal shall be for a period not exceeding 10 years. If an active substance is renewed as a low-risk substance, the approval period will be 15 years.

Before their expiry date, a new re-evaluation begins.

Technical Equivalence Assessment（TE assessment）

Technical equivalence assessment is conducted to assess whether a technical material (new source) is equivalent to reference source. Once approval, it is valid in the entire EU and the new source can be placed on the EU market freely.

There are 3 types of Technical Equivalence assessment, with their data requirements listed below:

Different circumstances	Data Requirements
Technical material coming from a new/different manufacturer	The data under points 1.1.-1.11 and 4.1 of Regulation (EU) No 283/2013 must be provided.
Large scale production vs. pilot scale production.	The data under point 1.11 of Regulation (EU) No 283/2013 must be provided. For points 1.1-1.10 a statement from the applicant is sufficient if there are no changes. The data under point 4.1 are required if there is a change to the impurity profile or if new analytical methods are used.
Change in the manufacturing process, and/or manufacturing location, and/or addition of one or more alternative manufacturing locations	The data under points 1.1.-1.11 of Regulation (EU) No 283/2013 must be provided. The data under point 4.1 are required if there is a change to the impurity profile or if new analytical methods are used.

Evaluation and Decision-Making Criteria for Technical Equivalence Assessment

Product Authorization

Authorization for PPP is on the level of member states. Authorization should be obtained for plant protection products in all Member States, where PPP is intended to be placed on the market.

To reduce duplicative work and shorten the time needed for products to enter EU market, PPPs Regulation has adopted regional evaluation system, in which EU Member States are divided into North Zone, Centre Zone and South Zone (as shown in below table) based on agricultural and climatic conditions.

The core dossier will be subjected to joint evaluation in the zone, which will be assessed for only once in the zone. But each Member States may have their own additional data requirements, such as efficacy, residues, environmental fate, etc., due to their specific agricultural and climate environmental conditions. Dossiers submitted by applicant to fulfill these requirements will be reviewed by each member state individually.

The entire EU is regarded as one area for evaluation when plant protection products are for the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, etc.

The specific process for enterprises to apply for regional authorization is as follows. When applying for formulation product authorization, the technical material used in the formulation product should be the reference source or a new source equivalent to the reference source (TE approved source).

In addition, the product dossier, evaluation draft report and evaluation decision will be sent to all other member states in the same region in addition to RMS in the evaluation process for formulation product authorization and accept the comments from these member states. In this way, once the product authorization is acquired in one member state, regional mutual recognition can be applied when seeking to export to other member states in the same region, which significantly decrease the time and cost of product authorization.

RMS Selection

Selecting RMS is a starting and key step to begin the procedure of application, such as technical equivalence assessment, application for product authorization.

The main consideration points when Selection RMS can be summarized as follows.

Renewal of Pesticide

Under PPPs Regulation, generally 10 years of validation period can be granted after first approval of active substance（except low-risk substance and candidate for substitution substance. No later than 3 years before the expiration of the active substance approval, the application on renewal of the active substance shall be submitted.

The validity period of authorization of PPP is relevant to the approval status of the active substance contained. As long as the active substance is in approval status, the authorization of PPP containing the active substance is always valid. After the approval of renewal of active substance, the PPP containing the active substance should also be renewed.

Data Protection

General period of data protection is 10 years starting from the date of first authorization in that Member State.

A study shall also be protected if it was necessary for the renewal or review of an authorization. The period for data protection shall be 30 months.

Since authorization of PPP is at country level, and the authorization time for a specific product is not the same in different member states, the data protection period is also different in different member states. Only the total protection period remains the same.

Our Services

Technical Equivalence Application
Application for Active Substance Approval/Renewal
Application for Product Authorization/ Me-too Registration
Product Compliance Analysis Report
Data Gap Analysis
Endocrine Disruption Risk Assessment
QSAR report
GLP study supervisor
Comprehensive Regulatory Consulting and Training Services
Establishment of EU Branch

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