In Article 35, under a, of the GMO Genetically Modified Organism Regulation 2013, a medical and a veterinarian category is indicated for cases where changes as mentioned in this article are identified as changes that have no consequences for the environmental risk assessment conducted.
This specifically concerns proposed changes to the applications of naked DNA in test subjects for which the permit is based on an environmental risk assessment for naked DNA that was drawn up by the Minister. If the proposed changes are indicated as having no consequences for the environmental risk assessment, these may be reported to the Minister, on the basis of Article 3.16 of the GMO Act 2013, and the permit issued earlier on the deliberate environmental release for other purposes also applies. For a general explanation of this procedure and the designated case categories, please refer to Section 4.3.2, under a, of the general part of the explanation of the GMO Regulation 2013.
There is a background dossier to the GMO Regulation 2013, which contains an environmental risk assessment drawn up by the Minister and which relates to Article 35, under a, about changes that must be notified. In addition, the background dossier also contains a summary of said environmental risk assessment. This assessment has been drawn up in accordance with the principles of Appendix II to the Directive 2001/18/EG on the deliberate release of GMOs into the environment. Starting point in the environmental risk assessment is that the naked DNA to be used must meet certain preconditions, and that only a limited number of administration methods will be used. This means that the environmental risk assessment can be widely applied as long as the naked DNA used and the administration methods meet the described preconditions.
This starting point for the environmental risk assessment to determine the category of cases to be notified has been established in:
- Article 35, under a7 and a8, which state the sequences that must not be present on the DNA, and
- Article 35, under a6, which states the permitted methods of application.
To be able to use this notification system, a permit is required for the medical application of naked DNA, which is based on an environmental risk assessment for naked DNA that has been drawn up by the Minister. Applicants may apply for such a permit for medical or veterinarian use by substantiating that the application and the composition of the DNA meets the requirements named in Article 35, under a, of the GMO Regulation 2013, and by subsequently attaching the appropriate standard risk assessment as drawn up by the Minister that is based on those same requirements as named in Article 35, under a.
The GMO Act 2013 can also be found onhttps://www.officielebekendmakingen.nl/stb-2014-157.html (in Dutch).
The GMO Regulation 2013 can also be found on https://www.officielebekendmakingen.nl/stcrt-2014-11317.html (in Dutch).