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Proposed New European Pesticides Regulation

27 January 2009

The European Parliament voted in favour of new regulations governing the authorisation of pesticides (plant protection products) on 13 January 2009, however the legislative procedure has not yet been finalised.

The next step is that the new regulations need to be formally agreed by the Council of Ministers (the Council). The timing for the Council to consider the new regulations is not clear, but is expected to occur in the first quarter of 2009.  If agreed by the Council full application of the legislation must be implemented by member states by early 2011.

Amongst other things, the new legislation proposes that highly toxic chemicals and substances that are carcinogenic, toxic to reproduction or causing mutations will not be approved unless the use pattern results in negligible exposure.  Chemicals that adversely effect development, are toxic to the immune system and contain endocrine disrupting chemicals will be banned if they pose a significant risk. Some of the criteria for defining these pesticide substances are not as yet precisely defined. For example, comprehensive criteria for endocrine disruption are yet to be developed.

Once in place the new legislation will apply to all new pesticide substances.  However for existing pesticides the impact of the new regulations will be a gradual process. Any substance already approved will remain approved until the current approval period (10 years) expires.  For example, a pesticide approved in 2006 will remain legal until 2016. Each chemical will then undergo evaluation by regulatory authorities before a final decision is made.

If the evaluation of a pesticide substance deems that it does not meet the new safety criteria but the pesticide is crucial for the protection of plant health, the legislation includes provisions that allow for approval for up to five years (with five-year renewals).  Products containing certain hazardous substances are to be replaced with a three year deadline if safer alternatives are shown to exist.

Regulatory agencies in several European countries have published their preliminary assessments of the likely impact of the new regulations. These vary significantly.
The regulations, however, do not specify any individual substances, nor propose any “black-list” of substances. Information published by European authorities state that there will be no sudden or large-scale withdrawal of products from the market.

The APVMA has been closely following the development of the proposed new regulations.  When conducting an existing chemical review or deciding to commence a review of an existing chemical the APVMA takes into account relevant international regulatory activities and reports.  The APVMA will continue to regularly engage with the European regulators through the Organisation for Economic Cooperation and Development (OECD) and other forums to help inform our regulatory decisions.

More information

For a European overview of the legislative process see Pesticides Legislation: The Final Lap (external website), an information sheet provided by the European Parliament.

See the preliminary assessment of the Swedish regulator (PDF, 178kb)(external website) as an example of the assessments being undertaken by individual European countries.