Regulations on the labeling, transport, import and export of genetically modified organisms.

Date of-2005-09-02-1009 Ministry climate and Environment Ministry published in the 2005 booklet 11 entry into force last modified 02.09.2005 FOR-2013-12-19-1757 from 01.01.2014 Change FOR-1998-11-13-1066 applies to Norway Pursuant LAW-1993-04-02-38-section 10, LAW-1993-04-02-38-section 14 Announced 09.09.2005 short title regulations on the labeling, etc. of the GMO Chapter overview: Chapter 1. General rules (sections 1-5) Chapter 2. Transport and import (§ § 6-14) Chapter 3. Export (sections 15-18) Chapter 4. Tagging (section 19) Chapter 5. Accident (§ § 20-21) Chapter 6. Implementation and enforcement provisions (§ § 22-27) legal authority: Provided by URKronprinsreg.res. september 2, 2005 with authorization in law 2. April 1993 No. 38 on the manufacture and use of genetically modified organisms (gene technology Act) § 10 third and fourth paragraphs and § 14. Promoted by the Ministry of the environment (now the climate and Environment Department).
Changes: modified by regulations March 15 2013 No. 284, 19 des 2013 No. 1757. Chapter 1. General rules section 1. Purpose the purpose of the regulation is to simplify the transport and import of genetically modified organisms, conduct Norway's obligations under the Cartagena Protocol on genetically modified organisms, ensure consumers ' choice and prevent the harmful effects of genetically modified organisms.

§ 2. The scope of the provisions in Chapter 2 about the transportation and import applies to genetically modified organisms as according to the gene technology law § 10 is approved for exposure as defined in the gene technology law section 9 a-e, or as according to the law § 7 is approved or signed for enclosed use as defined in section 5.
The provisions of Chapter 4 of the selection applies to genetically modified organisms as mentioned in the first paragraph, as well as genetically modified organisms which, according to the law § 10 is approved for exposure as defined in the law section 9 f, or that can be transported according to the law § 10 and the provisions of this regulation Chapter 2. Food, livestock feed and seed are exempt from the provisions of section 19, first and second paragraph.
Genetically modified organisms are in the scope of the current rules for the transport of dangerous goods are exempt from the provisions of section 7-section 8, section 10-section 14, section 18 and Chapter 4.
By the way the regulation applies for all genetically modified organisms.

§ 3. Definitions in this regulation means: genetically modified organisms: micro-organisms, plants and animals where the genetic composition is changed by the use of gene or cell technology.
Risk classes: microorganisms are classified in accordance with regulation 21. December 2001 No. about the use of 1600 enclosed genetically modified microorganisms, section 6. The business be classified into risk classes 1, 2, 3 or 4.

§ 4. General precautions the person responsible for labelling, transport, import and export of genetically modified organisms to ensure that the terms of this regulation is met, and otherwise show due care and take reasonable measures to ensure that all handling of genetically modified organisms takes place without the health and environmental impacts.

§ 5. Relationship to other regulations this regulation makes no restrictions in any claims arising out of other regulations about labeling, transport, import or export of plants, animals or micro-organisms.

Chapter 2. Transport and import section 6. A general rule for transport and import with the exception of genetically modified organisms as mentioned in section 7, can transport and import of the genetically modified organisms be without special approval if the forskriftens requirements for labelling and packaging is met. The transport of genetically modified organisms that are covered by, and meet the requirements of or is approved pursuant to the current rules for the transport of dangerous goods, can be transported without special approval for this regulation.

section 7. Transport and import that require authentication authentication is required for the transport and import of the following genetically modified organisms: a) genetically modified micro-organisms where your business is classified in risk class 3 and 4.

b) culture volume over 10 liters of genetically modified microorganisms where your business is classified in risk class 2.

c) live animals and plants that are used as the host organism for genetically modified micro-organisms.

d) all genetically modified animals, except 1.
traditional farm animals that do not have wild relatives in the Norwegian fauna as they can cross with, 2.
laboratory animals such as mice, rats, hamsters to be used in laboratories approved for enclosed use of genetically modified organisms, 3.
embryos, eggs, sperm, cell and tissue cultures of animal cells.

e) Transports where it is not possible to satisfy the forskriftens requirements for labelling and packaging.

section 8. The application's content application for transport and import should contain the following information: a) the name, address, telephone and fax to the following: the applicant, the person responsible under section 4, the sender, recipient and carrier.

b) information about packaging, means of transport, transport route and date of dispatch and receipt.

c) information about the organism: Taxonomic status, scientific name, common name, the characteristics of the genetically modified organism and the donor, resipient or any parent organisms.

d) quantity: the number of organisms/liter in culture volume and number of pieces of baggage to be transported and/or imported.

e) assessment of the environmental and health risks associated with the transport and/or the import process.

f) details about when and with what authority the genetically modified organism is approved/signed for enclosed use or exposure after the gene technology law section 7 and section 10.

g) precautions in connection with the handling of the organism.

h) safety procedures in connection with the accident.

in the) signature.

If necessary, the approval authority may require additional information from the applicant.

§ 9. Journaling All the transport and import of the genetically modified organisms to be journalized recipient in Norway, and also by the sender when both are located in Norway. The journal should describe the genetically modified organism in question, the date of dispatch and receipt, and result of the control with that everything has come forward. The journal shall at all times be accessible to the supervisory authority. Gjenpart of the transport documents should be attached to the journal.

§ 10. Accompanying document of transport (transport documents) Transport documents should be attached to all shipments of genetically modified organisms from sender to receiver. The documents must contain the following information in addition to those specified in section 19: a.
For genetically modified organisms destined for enclosed use;

1. that it is intended for enclosed use, 2.
description of the organism, including the common, scientific and, if available, commercial name of the organism, 3.
description of the gene modification, the technique used and the subsequent property changes to the organism, 4.
precautions in connection with the handling, storage, transport and use, 5.
risk class, 6.
specification of use, 7.
the unique identification code if such exists, and 8.
indication of a contact point for further information, including the recipient of the organism, as well as the exporter or the importer.

b. For genetically modified organisms to the exposure;

1. a statement that the transport is in accordance with the Cartagena Protocol requirements, 2.
description of the organism, including the common, scientific and, if available, commercial name of the organism, 3.
description of the gene modification, the technique used and the subsequent property changes to the organism, or a unique identification code, if such exist, 4.
precautions in connection with the handling, storage, transport and use, 5.
risk class, 6.
import permit if such permission is required under section 7, and 7.
indication of a contact point for further information, including the transmitter/receiver/exporter and importer.

section 11. Packaging genetically modified organisms shall be by transport are packed according to the provisions of section 12-section 14. The authentication authority can set other requirements on the packaging as a condition for approval.

§ 12. Packaging the packaging of micro-organisms to be dense, closed and secure etc. so that it prevents the content release inadvertently.
For microorganisms where the business is classified in risk class 2, 3 and 4 should always be an inner and an outer container that both are waterproof. Between the inner and the outer container should be a væskeabsorberende material that can record in as much liquid as it is inside the container. If multiple inner containers carried in the same outer container to each inner container are packed separately in the shock-and væskeabsorberende material. The outer container should be dense, closed, secure etc. so that it prevents the content release inadvertently.

section 13. Packaging of the plants and plant parts there should always be an inner and an outer container that both are track-and pollen clog. The outer container should be closed and secure etc. so that it prevents the content release inadvertently.

section 14. Packaging of the animal to be a cage Packaging or a container which ensures that the animals can't escape or cross themselves with other animals outside of the packaging. Packaging of embryos, eggs, sperm, cell and tissue cultures, should take place according to the rules in section 12 the first paragraph.

Chapter 3. Export section 15. Requirements for consent prior to the first export of genetically modified organisms for launching in the environment to countries outside the European economic area to collect, or exporter ensure that it collects, consent from the national, responsible authority in the importing country. Exporter shall send, or ensure that it is sent, the message with the information referred to in section 16 and section 17 to the competent national authority of the importing country. Export is not authorized and may not happen before the import country's authority has given written permission to the implementation. Exporter shall ensure that the information provided is correct.

Exporter is obliged to keep a copy of the message, the country's import receipts and written confirmation the import permit for a minimum of 5 years, and shall send a copy of these documents to the Environment Agency.
The following are exempt from the requirements of the first and second paragraph: a. Genetically modified organisms in transit or the export of genetically modified organisms destined for enclosed use when the transfer takes place in accordance with the requirements of the importing country.

b. export of genetically modified organisms to countries that have indicated to the mechanism for information exchange under the Cartagena Protocol that importing can happen without informed consent, provided that adequate measures be taken to ensure proper cross-border transfer of genetically modified organisms in accordance with the Cartagena Protocol purposes.

c. the export of genetically modified organisms intended for direct use as food, feed or for further processing to the countries which have made the decision on the import according to the national legislation that is in line with the Cartagena Protocol purposes, and-developing countries or countries with transition economies that have declared through the mechanism for information exchange that decision prior to the first import will be made in line with art. 11 no. 6 in the Cartagena Protocol. In such event shall export does not take place before the procedure in this article is complete. Lack of notification of the decision can neither be interpreted as consent to, or refusal of such import.

section 16. Message by the export of genetically modified organisms prior to the export of Message genetically modified organisms shall contain the following information: a. Eksportørens name, address and contact details.

b. the importer's name, address and contact details.

c. Name and identity of the living modified organism, possibly with the national classification of the level of the living modified organism in Norway.

d. the intended date or dates for the cross-border transfer, if known.

e. Taxonomic status, scientific name, common name, collection or acquisition location, as well as the characteristics of the recipient organism or parental organisms with regard to biosafety.

f. the originating centres and centres of genetic diversity, if known, of the recipient organism and/or parental organisms and a description of the habitats where the organisms may exist or multiply.

g. Taxonomic status, scientific name, common name, collection or acquisition place, as well as character traits of the donor organism (s) with respect to biosafety.

h. Description of the inserted nucleic acid or the modification performed, applied technology and the subsequent property changes to the living modified organism.

in the intended use of the ... the living modified organism or products of this, IE. refined material originating from the living modified organism and that contain demonstrable new combinations of genetic material by replikerbart brought to the world the use of modern biotechnology.

j. volume or volume of the living modified organism to be transferred.

k. Risk assessment report.

l. Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, renovation and emergency response procedures, when applicable.

m. Regulatory status of the living modified organism in Norway (for example, whether it is prohibited in the exporting State, about other restrictions apply, or whether it is approved for General exposure), and, if the living modified organism is banned in Norway, the reason or reasons for the ban.

n. result of and purpose of any message from the exporter to other States regarding the living modified organism to be transferred.

o. Statement that the above information is in accordance with the facts.

§ 17. Message by the export of genetically modified organisms intended for direct use for food, feed or processing Message prior to the export of genetically modified organisms intended for direct use for food, feed or processing shall contain the following information: a. your name and contact details of the authority responsible for the decision.

b. Name and identity of the living modified organism.

c. Description of the gene modification, the technique used and the subsequent property changes to the living modified organism.

d. Any unique identification of the living modified organism.

e. Taxonomic status, scientific name, common name, collection or acquisition location, as well as the characteristics of the recipient organism or parental organisms with regard to biosafety.

f. the originating centres and centres of genetic diversity, if known, of the recipient organism and/or parental organisms, as well as a description of the habitats where the organisms may exist or multiply.

g. Taxonomic status, scientific name, common name, collection or acquisition location and characteristics of the donor organism (s) with respect to biosafety.

h. Approved uses of the living modified organism.

in the Risk assessment. report.

j. Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, renovation and emergency response procedures when appropriate.

§ 18. Transmittal of information by the export of genetically modified organisms for export shall ensure that the exporter the following information, in addition to those specified in section 19, disclosed in the accompanying document and sent to the importer receiving the genetically modified organism: a. For genetically modified organisms intended for direct use as food, feed or for further processing a statement from the exporter that the genetically modified organisms are intended for such use and not to the launching in the environment , a contact point for further information, including the exporter, importer or the responsible authority in the exporting country, organismenes common, scientific and any commercial name.

b. For genetically modified organisms destined for enclosed use, common and scientific name of the organism, that it is designed for enclosed use, precautions in connection with the handling, storage, transport and use, and the designation of a contact point for further information, including the name and address of the who is to receive the organisms.

c. For genetically modified organisms intended for intentional exposure in the environment in the importing country, and any other genetically modified organisms that fall under the regulation, a statement from the exporter that the transport is in accordance with the Cartagena Protocol requirements of the exporter and with the following additional information: 1. information about the organism: common name and the scientific name and characteristics of the genetically modified organism, or a unique identification code if exists ,

2.
precautions in connection with the handling, storage, transport and use, and 3.
a contact point for further information, including the exporter and importer.

Chapter 4. Marking section 19. Marking Products consisting of or containing genetically modified organisms to be marked on the Norwegian and/or English with the words "contains genetically modified organisms"/"contains (name of the organism (s))" and/or "contains genetically modified organisms"/"contains genetically modified (name of organism (s))". On the packaged products to the selection be on a label on each packing unit. For other products should be disclosed in the information accompanying the document or spread.
The product's commercial name, name and address of the person within the European economic area who is responsible for the turnover of the product and where you can get additional information about the genetically modified organism as the product consists of, or contains, shall also be disclosed in the label or accompanying document.
For genetically modified organisms approved for revenue in addition to the unique identification code is specified in the accompanying document if such code is found. For mixtures of genetically modified organisms that can only be used directly as food, feed or processing unique identification code can be replaced by a statement that the mix is intended for such use, please find attached a list of the unique identification codes for all of the genetically modified organisms which have been used to make the mixture.

Chapter 5. Accident section 20. Report Accident during transport that has resulted or may result in the release of genetically modified organisms shall without undue delay be reported to the Environment Agency. Accident where the genetically modified organisms are classified as dangerous goods shall also be reported to the local fire and Rescue Department.

§ 21. Emergency responsibility the person responsible under section 4 has the duty to avert and to limit the damage after the genetic engineering law § 21.

Chapter 6. Implementation and enforcement provisions to section 22. Approval and supervision Environment Directorate approves the application for transport and import of genetically modified organisms, and oversees that the provisions in the regulations are observed. The authorities should treat the application as quickly as possible. If the matter is not settled within a month after the authorities received the application, the applicant shall be informed in writing about this and about when the outcome is believed to be released.

§ 23. Exceptions Regulatory Authority can, if there are special reasons, by individual decisions or regulations make exceptions from the provisions of this regulation.

section 24. Penalty Violation of this regulation is punishable by genetic engineering law § 25.

§ 25. Coercive to ensure that the provisions of these regulations or decisions made pursuant to these regulations are implemented, the supervisory authority see decision on coercive, jf. Gene Technology Act section 24.

§ 26. Complaint pursuant to individual decisions hit of this Regulation may be appealed to the climate and Environment Department.

§ 27. Ikraftsetting this regulation will take effect immediately. From the same time repealed regulations 13. November 1998 No. 1066 on the transport and import of genetically modified organisms.