Placing GMO products on the market (including import)

1. Placing GMO products on the market in the territory of the Republic of Poland shall require a permit from the Minister granted upon the application of the interested GMO user.
2. Placing on the market of a GMO product, a product containing GMO, or manufactured with the use of a GMO product or products listed in the register of GMO products as permitted to be placed on the market shall require no separate consent. When introducing such products to the Polish customs area, the customs declaration must include an extract from the Register of GMO Products,
3. Placing on the market of a GMO product which consists of the same GMOs or a combination of GMOs, which is to be used in a manner other than the GMO product permitted to be placed on the market shall require a separate permit,
4. The application for consent for the Placing on the market of a GMO product with the additional documentation are submitted to the Minister of The Environment.
5. The application for consent for the Placing on the market of a GMO product is covered by the annex 3 of the Regulation of the Minister of the Environment laying down the formats of application forms for consent and authorization of activities involving genetically modified organisms (OJ 2002 No. 87, Item 797).
6. The application is registered in accordance with the office order compulsory in the Ministry , formally verified by the substantial unit competent for GMO issues. The following elements are usually checked:
   1. information on the GMO user including his business name and seat, or the first and last name and address,
   2. information on the GMO product:
      • product description,
      • instructions or recommendations for use and storage,
      • information on GMO contained in the product including description of GMOs, and recipient or parental organisms which the GMO was obtained from,
   3. information on recommended safety measures related to safe use of the GMO product and potential hazard to human health or environment which may result from non-compliant use of the GMO product,
   4. information on the packaging and marking of the GMO product,
   5. information on permits obtained for the GMO product for placing on the markets of other countries and any refusals to grant such permits.

• documentation confirming that the GMOs used for or included in the product had been previously used in the contained use process or released into the environment pursuant to the governing rules of the law,
• documentation confirming that following the contained use or release of the GMOs into the environment human health or the environment were not endangered,
• documentation of the risk assessment.

The risk assessment shall be carried out in a manner verifiable against available scientific and technical data given direct and indirect hazards, which may occur in the short- and long-term, in accordance with requirements which are covered by Regulation of the Minister of the Environment laying down the detailed manner of carrying out the assessment of risks to human health and the environment related to the undertaking of activities involving the contained use of GMOs, the deliberate release of GMOs into the environment, including the placing of GMO products on the market, and the requirements which should be satisfied by the documentation containing the results of such an assessment (O J 2002, 107, 944). The documentation of the risk assessment shall consist of :

• an assessment of the risks to human health and the environment, along with the related conclusions, including references to information contained in the applications for the consents,
• a description of the methods used to perform an assessment of the risks to human health and the environment.

7. After verification the application is sent to the commission on GMO in the aim of preparation of an opinion.
8. The commission assesses the information from application taking into account scientific point of view.
9. The commission verifies risk assessment related to placing on the market GMO product taking into account potential risks for human health and environment, which may carry out the utilisation of the specific GMO. Before the granting of the opinion, commission shall require an additional information or shall recommend preparation of an independent expertise.
10. The Commission shall give opinion in the form of resolution, which is adopted in an open vote. Resolutions shall be adopted by an ordinary majority of votes.
11. The permit for placing on the market GMO product shall be issued within three months of the receipt of the application. Pending deadline shall be suspended if the application should be completed or additional information should be submitted.
12. In the proceedings consisting of granting a permit for placing on the market GMO public participation is possible. This participation shall be regulated by rules on public environmental proceeding protection participation. In accordance with art. 24 para. 1a In case of public participation the deadline for the issue of permit for the placing on the market GMO referred to in subsection 1 shall be prolonged by the time of consultation, however, not longer than 30 days.
13. The permit to place GMO product on the market a shall be issued for a definite period of time not longer than 10 years.

1. The same user may place the GMO product on the market again if he obtains another permit for placing the product on the market.
2. The GMO user shall notify the Minister of planned subsequent placing of the GMO product on the market referred to in subsection 1 nine months before expiry of the original permit.
3. The notification shall contain:
   • a copy of the original permit to place the GMO product on the market,
   • a report on the results of monitoring referred to in Section 45,
   • new information obtained by the user and pertaining to hazard to human health or environment related to placing the GMO product on the market,
   • where appropriate, a proposal to alter or complement conditions contained in the original permit in particular conditions regarding monitoring and time restriction of the permit.
4. Until a new permit for placing the GMO product on the market is obtained, the GMO user may continue to place the GMO product on the market under conditions specified in the original permit.

1. For the sake of public interest of particular importance to protection of human health and the environment and in particular the risk of environment deterioration, the permit for the placing on the market GMO product shall include a security of claims resulting from potential damages.
2. In cases justified on the grounds of protection of human health or the environment, the permit shall oblige the GMO user to provide additional packaging to prevent release of GMOs to the environment during transportation, storage, or at later stages of placing them on the market, or shall specify additional requirements for placing GMO products on the market.
3. The Minister of the Environment may ordain removing a GMO product out of trade in case of receiving new additional information on hazardous effects on human health, until the GMO user will have submitted the report on the undertaken activities aimed to guaranteed fulfilment of the provisions of act, especially those on human health and the protection of the environment.

1. The GMO user shall be obliged to monitor placing on the market of GMO products, which he obtained the permit for and risks related to the placing on the market.
2. The GMO user shall be obliged to immediately notify the Minister if there are new circumstances affecting the contents of the documentation attached to the application.
3. The user shall be obliged to undertake necessary steps to intervene or withdraw GMO products from the market if this is required to protect human health or the environment, if new information on risk to human health or the environment related to placing GMO products on the market is made available to him.
4. The user shall be obliged to label GMO products, which he obtained the permit for in accordance with the art. 47 of Act on GMO.
5. The GMO user who obtained the permit for placing the GMO product on the market shall be obliged to collect and store controls samples and make them available at each request of the Minister or control authorities.

1. The Minister shall, by means of a decision, temporarily prohibit or restrict trading the GMO product if there are reasons to believe that it endangers human health or the environment. Such decisions shall be enforced immediately.
2. The permit to place the GMO product on the market may be revoked or altered if there is new information important for assessment of hazards to human health or environment related to placing the GMO product on the market.

• applications for the consent for placing the GMO product on the market with attached documentation,
• consent for placing the GMO product on the market with justification and information on revocation or alteration of the consent,
• decisions on the prohibition or limitation of trading the GMO product with justification,
• opinions of the Commission,
• information on risk to human health or environment and undertaken interventions.