Reference Laboratories on GMOs

Reference laboratories may be established to conduct tests of GMO products and issue opinions on GMOs. A permit for running a reference laboratory shall be issued by the Minister upon application of the interested party.

The application shall contain:

1. identification of the entity applying for the permit including seat and address,

2. number in the register relevant for the applying entity,

3. specification of the requested scope of permit,

4. information on the staff employed by the entity including their qualifications,

5. information on the GMO research experience,

6. information on complaint and appeal procedures in the scope of activities pursued,

7. information on readiness to commence research and pass opinions,

8. specification of services provided.

A certificate of accreditation granted under the rules of the Act of 30 August 2002 on the compliance assessment system (Journal of Laws No. 166 item 1360) shall be attached to the application

Deadline for the opinion on GMO products with short expiry date is 3 days from the day the material is provided for examination and for the remaining products the deadline cannot exceed 7 days from the day the material is provided for examination.
Duties of reference laboratories shall include:

1. conduct of analyses and research and issuing opinions on GMOs,

2. conduct of analyses and research and issuing opinions on GMOs if there are discrepancies, questions, or the need to confirm results obtained in the course of analyses and research conducted by other laboratories including laboratories which belong to inspections,

3. elaboration of methodology used to detect GMOs in particular:

   1. preparation of a list of DNA fragments most frequently used for genetic modification of plants, animals, and microorganisms,

   2. elaboration of primers for the Polymerase Chain Reaction (PCR) which specifically recognize DNA sequences most frequently used for genetic modification of plants, animals, and microorganisms,

   3. elaboration of conditions of the Polymerase Chain Reaction (PCR), which support specific and reliable propagation of DNA fragments from transgenes,

   4. elaboration of non-standard methods of detecting transgenes in GMO products,

   5. performance of analyses to confirm presence of genetic material elements in the environment with the application of coupled techniques of LMCS-mass spectrometry and liquid chromatography and ELISA,

   6. preparation of a detailed manual to conduct analyses listed in subparagraphs a)-e),

   7. standardisation of conditions for the conduct of analyses referred to in subparagraphs a)-e),

4. possession of DNA fragment standards for the PCR technique to identify types of introduced genetic modification,

5. organisation of comparative research for various methods of analysis,

6. unification of certain methods of analysis,

7. unification of research methods and procedures,

8. implementation of new research methods,

9. supplying to the Minister information pertaining to methods of analyses and comparative research applied by reference laboratories of the Member States,

10. training of laboratory staff of the bodies referred to in paragraph 2 in new methods of analysis and research,

11. partnership with reference laboratories of other countries.

The Minister shall announce, by means of an announcement in the Official Journal, a list of reference laboratories and other laboratories which carry out GMO control related tasks including the scope of research carried out by these laboratories.

The Minister of the Environment has issued The Regulation of 16 May 2002 laying down the substantive scope of research to be carried out by entities which apply to perform research and give opinions in the field of genetically modified organisms (Official Journal 02.73.674)