|  European Union regulatory information
 Overview
of Pesticide Regulation in the European Union
The
Process of Evaluation of Active Ingredients
Re-evaluation
of Existing Active Ingredients
Evaluation
of New Active Ingredients
Glossary
of Terms
Overview
of Pesticide Regulation in the European Union The
European Community (EC) has established a harmonized legal framework
for the regulation of pesticides in all member countries of the
EC. The Commission of the European Communities, in collaboration
with member countries of the EC, is responsible for the registration
of pesticide active ingredients (also referred to as active
substances) for use in all EC member countries. Individual
member countries, called Member States, are responsible for the
registration in their country of specific pesticide products
containing active ingredients authorized for use by the Commission
(click here for information
on the difference between pesticide active ingredients and pesticide
products). This dual authority of the EC and its member states is
granted by the Council of the European Community under Council Directive
91/414/EEC, adopted on July 15, 1991 and effective July 25, 1993
(1). Standards and regulations for the classifications, labeling,
and packaging of pesticides are set by Council Directive 67/548/EEC
of June 27, 1967 (2).
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The
Process of Evaluation of Active Ingredients The
EC pesticide registration procedure establishes uniform standards
for both the re-evaluation of active ingredients on the market in
the EC on or before July 25, 1993 (called existing active ingredients),
and the registration of new active ingredients introduced after
this date. The evaluation of a new active ingredient begins when
a pesticide manufacturer submits an application, called a dossier,
to the Member State of their choice. Once the Commission determines
that all required information is included in the dossier, any Member
State can grant a renewable 3-year provisional authorization
to an active ingredient for use in their country. Provisional authorizations
are granted before an active ingredient has been fully evaluated
and approved by the EC.
All existing
active ingredients on the market in the EC on or before July 25,
1993 were automatically authorized for an initial review period
of 12 years. During this time, pesticide manufacturers wishing to
have existing active ingredients authorized beyond the 12-year re-evaluation
timeframe are required to submit a dossier to a Member State of
their choice for re-evaluation by the Member State and the Commission.
The master list of pesticide active ingredients approved for use
in the EC are included in an Indicative List in Annex I
of the Directive 91/414/EEC. Individual Member States maintain records
of active ingredients that have been granted provisional authorizations
pending a Commission decision on their full authorization throughout
the EC. Official decisions to include active ingredients in Annex
I are made through the release of Commission Directives. Decisions
to withdraw active ingredients from Annex I are made through the
release of Commission Decisions. The European Commission in the
Official Journal of the European Community (OJ) publishes both types
of legislation.
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Re-evaluation
of Existing Active Ingredients Pesticide
active ingredients registered for use in at least one EC country
before Council Directive 91/414/EEC were automatically approved
for use in the EC and added to Annex I. The Directive established
a 12-year timeframe for the re-evaluation of these substances based
upon uniform criteria. Before the evaluation process for an existing
active ingredient begins, the manufacturer of the pesticide (the
Notifier) must submit an application for review, called
a dossier. The dossier includes information on risks posed by the
active ingredient to humans, the environment, and non-target wildlife.The
pesticide manufacturer may submit the dossier to the EC Member State
of their choice, designated as the Rapporteur Member State (RMS).
Pesticide manufacturers
wishing to have certain existing active ingredients added to Annex
I are provided with deadlines through Commission Regulation No.
933/94 for the submission to the designated Rapporteur State of
a complete dossier of data required for evaluation.Uniform data
requirements for dossiers are stipulated in Annex I of Council Directive
91/414/EEC. Upon receipt of the dossier, the Rapporteur Member State
must verify that all required data are included, or that justifications
are given for the lacking information. The Rapporteur Member State
then has 12 months to develop a draft assessment of the dossier
for submission to the Commission. The ECCO Peer Review team representing
several Member States then confirms the assessments and data gaps
identified by the Rapporteur State. When the data gaps have been
filled, the data package is submitted to the Evaluation Working
Group of the Standing Committee on Plant Health (SCPH) of the Commission
of the European Communities, wherein a series of technical discussions
occur between representatives of all Member States. Finally, the
dossier is submitted to the Commission with a recommendation to:
- Keep the
ingredient in Annex I
- Remove the
substance from Annex I,
- Suspend
the substance from sale on the market pending the provision of
further data, or
- Postpone
making a decision on the substance pending the provision of further
data.
If a negative
decision on the inclusion of the active ingredient is expected,
the data package is forwarded to the Legislative Working Group of
the SCPH. If a scientific opinion is needed on a matter, the data
package is forwarded to the Scientific Committee on Plants (SCP).
The SCP then forwards the package to the SCPH, which works with
the Commission to formulate a final decision on the inclusion or
exclusion of the active ingredient in Annex I.
Although Council
Directive 19/414/EEC initially established a 12-year re-evaluation
timeframe for the 834 pesticide active ingredients on the market
at the time of its entry into force, a July 12, 2001 report from
the Commission suggested that the Council extend this deadline to
a more feasible end-date in 2008. Currently, evaluation of the first
priority list of 90 existing active ingredients, initiated in 1992,
is not yet complete.(9) As of June 27, 2002, out of the 90 first
priority active ingredients to be reevaluated:
- 15 active
ingredients have been included in Annex I by Commission Directives.
- 18 active
ingredients have been removed from Annex I and withdrawn from
the market by Commission Decision.
- Decisions
on 37 active ingredients have been postponed.
- Requests
for additional data on 11 active ingredients have been sent out.
- 8 active
ingredients are undergoing or are scheduled for review.
Details on
the status of the 834 existing active ingredients in all priority
lists can be found at the EC
web site.
Prioritization
for Re-evaluation
Existing active
substances were divided into four priority lists for review, prioritizing
for evaluation those most widely used on the market and those of
clear concern. Reference 3 provides more detail on the process of
prioritzation and how it has changed over time.
- List
1: The
first priority list of 90 active ingredients.(Commission Regulation
No. 3600/92)
- Lists
2 and 3: The next set of priority active ingredients.
(Commission Regulation No. 451/2000)
- List
4: The fourth priority list includes all existing active
ingredients not included in the first three priority lists. List
4 includes substances of biological origin or used in foods, as
well as commodity chemicals and chemicals used exclusively on
stored plant products or exclusively as rodenticides, and substances
used in traps or dispensers.
Commission
Regulation No. 933/93 allocates responsibility for the individual
evaluation of selected active ingredients to Member States based
on country size; each chosen country acts as a Rapporteur State.
Evaluation
of New Active Ingredients and Provisional Authorizations
Council Directive
91/414/EEC also mandates the procedure for evaluating new active
ingredients introduced after July 25, 1993. The evaluation of a
new active ingredient begins whenever a pesticide manufacturer provides
the EC Member State of their choice with a dossier of information
on a new active ingredient for review. After the Member State determines
that all scientific studies necessary for evaluation are present,
and that the active ingredient will likely satisfy the requirements
of Directive 91/414/EEC, the dossier is passed to a Committee of
the Commission of the European Communities. The Committee then makes
an official Commission decision on the completeness of the dossier.
If the Commission
accepts the dossier as complete, any EC Member State can grant a
renewable 3-year Provisional Authorization for the use of the active
ingredient in their country. New active ingredients with these provisional
authorizations can be legally used in EC Member States before the
Commission fully evaluates the substances and any human health and
ecological effects they may have.
In order to
determine an accurate list of pesticide active ingredients registered
for use in an EC country, one must consult both Annex I and directly
with the country’s responsible authority. Authorization of
the pesticide products containing Annex I-approved or provisionally
authorized active ingredients is conducted at the national level.
However, Annex II of Council Directive 91/414/EEC outlines the uniform
requirements for information submitted for the authorization of
a pesticide product in any EC Member State.
Since 1993,
pesticide manufacturers have submitted the majority of dossiers
applications to France and Germany, which represent a large potential
market for pesticides. The EC Member States currently have 89 new
substances at various stages of the review process, with decisions
having been made on 22 (21 for inclusion in Annex I). Approximately
eight new applications for inclusion of a new active ingredient
in Annex I are received in the EC annually. The Commission has recently
reported that a number of new active ingredients pose a significant
regulatory and scientific challenge due to problematic issues such
as the leaching of metabolites into groundwater.
References:
- Plant
Protection Products, The European Commission, Top
level web page. Viewed on October 31, 2002.
- Report from the Commission to the European Parliament and
the Council: Evaluation of the active substances of plant protection
products, 12 July 2001, download.
Viewed on October 31, 2002.
- Technical Annex to Report in reference 2. Download.
Viewed on
June 27, 2002. Existing Active Substances,
The European Commission, Top
level web page. Viewed on October 31, 2002.
- New Active Substances, The European Commission, Top
level web page. Viewed on October 31, 2002.
- Overview
of the State of Main Works in DG Health and Consumer Protection
E.1 with Regard to the Implementation of Directive 91/414/EEC,
European Commission Services, June 18, 2002, June 18, 2002.
Download.
Viewed on October 31, 2002.
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Glossary
of Terms Member
State – a country in the European Community (EC).
Annex
I – amendment to Council Directive 91/414/EEC that
includes the Indicative List.
Annex
II – amendment to Council Directive 91/414/EEC stating
the uniform data requirements for dossiers submitted to Rapporteur
States for evaluation and/or re-evaluation of active ingredients.
Annex
III – amendment to Council Directive 91/414/EEC that
outlines the uniform requirements for information submitted for
the authorization of a pesticide product in a Member State.
Indicative
List – section of Annex I of Council Directive 91/414/EEC
that includes a list of all pesticide active ingredients approved
by the Commission of the European Communities for use in all EC
Member States; does not include active ingredients granted provisional
authorizations for use in individual Member States.
New
Active Ingredients – pesticide active ingredients
introduced to the market by pesticide manufacturers after July 25,
1993; new active ingredients may be granted provisional authorization
for use in individual Member States before being evaluated and approved
by the Commission of the European Communities.
Existing
Active Ingredients – pesticide active ingredients
authorized for use in one or more EC Member States on or before
July 25, 1993; the 834 existing active ingredients were approved
for use in the EC for an initial re-evaluation period of 12 years,
pending an EC decision on their permanent inclusion or exclusion
from the Indicative List of Annex I, Council Directive 91/414/EEC.
Commission
Directives – legislation released by the Commission
of the European Communities and published in the Official Journal
of the European Community (OJ); Commission Directives are issued
to publish official decisions on the inclusion of active ingredients
in Annex I.
Commission
Decisions - legislation released by the Commission of the
European Communities and published in the Official Journal of the
European Community (OJ); Commission Decisions are issued to publish
official decisions on the withdrawal of active ingredients from
Annex I.
Rapporteur
State – an EC Member State responsible for the evaluation
and/or re-evaluation of a new or existing active ingredient.
Notifier
– the pesticide manufacturer petitioning an EC Member State
for the inclusion of a pesticide active ingredient in Annex I.
Dossier
– application for the evaluation and/or re-evaluation of a
pesticide active ingredient submitted by a pesticide manufacturer
to a Rapporteur Member State.
Last
updated
November 11, 2002
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