Authorisation Directive (1991/414)

Title: The Authorisation Directive

Category: EU Directive

Date: 1993

References: 91/414/EEC [Full text]

General Description:

Note: This Directive has been repealed by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant .protection products on the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.

This Directive is known as the Authorisation Directive and is intended to harmonise national arrangements for the authorisation of plant protection products within the European Union. It became effective in 1993.

Under this Directive, members states are responsible for authorisation, within their own territory, of products containing active substances that appear in a list compiled at community level. However, common assessment criteria must be used. These criteria include efficacy and crop tolerance, physicochemical and technical data including toxicology, environmental persistence, behaviour in soil, water and air and effects on non-target organisms.

The Community list, known as "Annex 1" will vary over time as new products are granted approval and others prohibited.

The Approvals process is as follows:

Step 1

Company seeking authorisation generates the data required as listed in Annex I and II for the new active substance. This can take up to four years and cost millions.

Step 2

The data is submitted as a package to one or more EU Member State regulatory authorities. In the UK this is PSD.

Step 3

The data is first checked for completeness and then a Member State is appointed as Rapporteur. This is published in the EUs Official Journal. Step 3 usually takes around 1 year.

Step 4

The Rapporteur Member State reviews the data and prepares and evaluation document called a Monograph. In parallel Member States may grant a provisional product registration for a period of three years. Step 4 also takes about 1 year to complete.

Step 5

The Monograph is circulated to all Member States and considered by the European Commission Co-ordination Group (EECO) If accepted, ECCO makes a recommendation to the EU Commission that the active substance be included on to Annex 1. This step again takes around 1 year to complete.

Step 6

The EU Commissions Standing Committee on Plant Health reviews the recommendation. They have the power to endorse, change or reject the recommendation. This step is usually completed in about 6 months.

Step 7

Once the active substance has been included on to Annex I, data sets as listed in Annex III for formulated products can be submitted to Member States. These must be authorised by every Member State where the formulation will be sold. This process can take around 1 year to complete.

Pertinence to Agriculture: Pesticides, Pest Control

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