Most of the legislation for LMOs as applicable in the Netherlands is based on EU legislation. The most important legislative instruments for LMOs are directives 2001/18/EC and 2009/41/EC and regulations EC/1829/2003, EC/1830/2003 and EC/1946/2003. For details on the EU legislation on LMOs, please see the report of the European Union. <br /><br />EU regulations are directly applicable in all Member States. However, Member States are responsible for the penalisation of infringements of the regulations. In the Netherlands, infringement of the EU regulations has been included in the Law onn Economic Offenses, with penalties ranging from fines to inprisonment. <br /><br />EU directives are implemented in the national legislation of Member States. In the Netherlands, the EU directives on LMOs have been implemented in the Genetically Modified Organisms Act (GMO Act). This Act contains rules for contained use, introduction into the environment of LMOs and introduction into the environment of LMO-FFP’s. A courtesy translation of this Act is available through the BCH.

Placing on the market of LMO's which are pharmaceuticals is regulated at EU level. Please refer to the report of the European Union for details. <br /><br />Clinical trials in the Netherlands with LMO's that are farmaceuticals are covered by the GMO Act, as mentioned under question 21, which has been submitted to the BCH.<br />

The GMO act also applies to transit and contained use of GMOs.

Decision making on transboundary movements of LMO's for intentional introduction to the environment for commercial purposes is regulated at EU level. Please refer to the report of the EU for details. Introduction to the environment of LMO's for experimental purposes (field trials) is regulated at national level. In the Netherlands, the procedure for obtaining authorisation for field trials is laid down in the GMO Act. This procedure is in line with the requirements of articles 7 to 10 of the Protocol. Requests for authorisation for field trials under the GMO Act are considered notifications in the context of the Protocol. No differentiation is made between field trials with imported GMOs or locally developed GMOs.Given the specificities of the national procedure, it is not possible to calculate the percentages required in question 48.&nbsp;

Please note that the authorisation of LMO-FFPs is regulated at EU level. Therefore, the decisions referred to in the answers in this section are valid in the Netherlands, but are taken (and submitted to the BCH) by the European Union.

Authorisations for field trials granted under the GMO act can be changed at the request of the applicant or on the initiative of the competent authority. In practice, a few authorisations have been amended for administrative reasons.

No simplified procedure has been used to date.

The Netherlands has not entered in any&nbsp; arrangements or agreements that are relevant in the context of Article 14.

Decisions on import of LMO-FFP's are taken at the EU level. In the Netherlands, several decisions have been made on authorisations for field trials in the reporting period. In all cases, the notifier is required to conduct the primary risk assessment and bear any costs involved. The risk assessment provided by the notifier is evaluated by the ministry. If the risk assessment is found to be complete and accurate, a decision in line with the risk assessment is taken by the minstry. The decisions, including the risk assessments, are maintained in a database.&nbsp;

For field trials, risk management measures are put in place to manage risks identified in the risk assessment. The Netherlands has participated actively in the discussions on Risk Assessment and Risk Management in the context of the Biosafety Protocol.&nbsp;

In the reporting period, an unintended introduction into the environment of an LMO was reported. However, it was not considered likely that the incident would have adverse effects on the conservation and sustainable use of biological diversity, taking also into account human health. Therefore, action was undertaken to remedy the unintentional introduction, but no further action was undertaken in the context of article 17 of the Protocol.

Detailed requirements for handling, transport, packaging and identification of LMO's are included in the EU legislation. Please refer to the report of the EU for details. These requirements are also valid in the Netherlands. In the Netherlands, the requirements are enforced by the national inspection agencies.

Under the GMO Act, notifiers can request for certain information in the notification that the notifier wishes to keep confidential. The competent authority decides whether this request can be upheld. This decision is based on national and EU legislation. In line with article 21.6, there are limits to the possibilities for the notifier to keep information confidential. In addition, EU legislation prevents keeping the location of field trials confidential.

The institutional capacity in biosafety was well developed at the beginning of the reporting period, and has not changed significantly during the reporting period. The Netherlands supports capacity building projects through several channels.<br /><br />Regarding question 138:Resources have been made available not only via multilateral channels, buts also via bilateral and regional channels.

For public awareness and participation initiatives at the EU level, please refer to the report of the EU. The Netherlands has detailed legislative instruments in place that provide public awareness and participation in decisions on LMO's. In brief the public is involved in decisions on field trials with LMOs by public announcements on the internet and in newspapers of any intention to authorise a field trial. The public is subsequently given the possibility to provide input for the decision making process for a specified period of time. Any input received is taken into account when taking a final decision. These decisions can be appealed to in court by individuals or organisations whose interests are affected by the decision. In the Netherlands, members of the public frequently make use of the possibilities provided for in the legislation to participate in decision making on LMO's.

The incident referred to here is the same as the incident referred to in the questions on article 17, since the introduction to the environment of the LMOs was both unintended and illegal.

The Netherlands has exchanged information with several Parties, mostly within the EU, on socio-economic aspects of LMO's.

The Netherlands has signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress on March 7th, 2011. Currently, preparations are being made for ratifying the Supplementary Protocol.

As indicated in a number of the answers above, the Protocol has been partially implemented at EU level and partially implemented at national level. Therefore, in many cases, the information in this report should be considered in combination with the information in the EU report.

No experience

Please refer to the survey report from the European Commission.