Certain adaptations to the EU regulation (EC) No 1107/2009 applies for Norway in risk assessments of plant protection products. The Norwegian adaptations to the EU regulation (EC) No 1107/2009 are described in the Decision of the EFTA Joint Committee No 203/2014.
As an EFTA State, Norway is free to limit access to thei Norwegian market for plant protection products containing active substances approved in accordance with Council Directive 91/414/EC or according to the Transitional measures in Article 80 of Regulation (EC) No 1107/2009. The following criteria may be used in such circumstances:
- it is not or has not been classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as mutagen category 1A or 1B, carcinogen category 1A or 1B, toxic for reproduction category 1A or 1B.
- it is not an endocrine disruptor as defined in the Regulation (EC) No 1107/2009.
- it is not considered to be a persistent organic pollutant (POP*) or a persistent, bioaccumulative and toxic (PBT*) substance.
- the active substance (or its metabolites) is not detected in the field after > 1 year, the DT90 is not > 1 year and the DT50 is not > 3 months.
- the concentration of the active substance or of relevant metabolites** in groundwater does not exceed 0.1 µg/L, unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.
- data from JOVA (The Norwegian Agricultural Environmental Monitoring Programme) do not show any findings above the Norwegian risk indicator value (MF) or continuous detections that indicate a risk, or data from other studies under Norwegian conditions do not indicate unacceptable risk to the environment.
- it is established that the use of the plant protection product has no unacceptable risk to bees.
*as defined in Regulation (EC) No 1107/2009
** according to the guidance document on the assessment of relevance of metabolites in ground water (SANCO/221/2000 – rev.10, 25 February 2003)
The Norwegian Food Safety Authority may apply the precautionary principle to ensure that such substances placed on the market do not have any harmful effects on human or animal health or any unacceptable effects on the environment.
Plant protection products approved in Norway before regulation 1107/2009/EC entered into force 1 June 2015, may continue to be kept on the market pending the zonal re-registration procedure in the EU.