Non-Tariff Barriers

Non-Tariff Measure

NTM classification

B14: Authorization requirements for importing certain products 

Date when the measure came into force

28 November 2014 

Publication where the measure is specified

Biosafety Regulation Concerning the Management of Genetically Modified Organisms 

Regulation where the measure is specified

Biosafety Regulation Concerning the Management of Genetically Modified Organisms 

Country/Region applying the measure

Mozambique 

Coded list of objectives

A: Protection of human life and health, B: Protection of life and health of animals, C: Protection of life and health of plants and E: Protection of the environment 

Description of the measure

Article 13
(Human and animal consumption or processing)
1. Without prejudice to the applicable legislation, the importation of GMOs and their products for human and animal consumption, as well as food processing, requires the authorization of the National Biosafety Authority, in addition to the general requirements, observe the following:
A) Submit the risk assessment and management report for public health and the environment, including the monitoring measures provided for in Article 44 of the present Regulation;
B) Present the information required under this Regulation.
2. The operator may be required to submit samples for testing purposes.
3. Upon assessment of the required documentation, the National Biosafety Authority shall take a decision on the import application for human, animal or processing purposes and notify the operator within ninety days.
4. The entry of GMOs and their products must be carried out under the conditions described in the authorization, at the dates and points of entry indicated therein, and may include several lots of the same merchandise
5. The validity of the authorization shall be one year, at the end of which the operator shall request a new authorization.
Article 14 (Emergency)
1. The importation of GMOs or their products for emergency purposes, officially decreed by the competent body for this purpose, may only be carried out with the authorization of the National Biosafety Authority and only in cases of extreme necessity, provided that there are no alternative solutions for Emergency response, and shall only be allowed for products intended for human consumption.
2. GM foods imported under this Regulation must be pre-processed prior to their being made available to final recipients to avoid their use as seed.
3. The request for importation for emergency is made under proposal of the National Institute of Disaster Management (INGC), accompanied by an official document that decrees the emergency.
4. The import authorization obtained shall be valid only for the duration of the emergency.
5. The National Biosafety Authority shall take a decision on the import request for emergency within a maximum period of 15 working days.
6. In case of need for additional information, the period referred to in the previous number may be extended by a further fifteen days.
7. For the purposes of paragraph 1 of this Article, the operator shall describe the monitoring measures that the importing entity must take in the process of importing and transporting GMO-containing foods.
8. The National Biosafety Authority may request the submission of samples for the purpose of testing.
9. Entities that wish to carry out the same operation for the second time shall submit a copy of the documentation used at the time of the first request for the same product.
Article 15 (Importation for use in containment conditions)
1. Without prejudice to the applicable legislation, the importation of GMOs and their products by any person or entity, public or private for use in containment conditions, requires authorization from the National Biosafety Authority, and the operator, in addition to the requirements General, please note the following:
(A) ensure that the development of GMOs and their products is carried out under containment conditions;
B) To prove that the laboratory and the greenhouses comply with the safety standards and are duly accredited to carry out activities with GMOs in containment conditions in the national territory.
2. Upon examination of the required documentation, the National Biosafety Authority shall take a decision on the import application for use in containment conditions and notify the operator within ninety days at the latest.
3. The authorization shall be valid for imports into a single batch, which shall be carried out within a period of six months.
Article 16 (Importation for confined tests)
1. Without prejudice to the applicable legislation, the import of GMOs and their products by any person or entity, public or private, for the purpose of confined testing, requires the authorization of the National Biosafety Authority, in addition to the requirements General, please note the following:
(A) present the results of studies conducted under containment conditions within or outside the country including the description of the GMO, the target species, the receiving environment and risk assessment information;
B) Present the proposed research project;
(C) submit an application for registration of GMOs and their products;
(D) provide information on the measures to be taken for the containment of GMOs and their products within the test site, as well as for monitoring, control and risk management of the activity in order to ensure safety for human health and the environment.
2. Upon examination of the required documentation, the National Biosafety Authority shall take a decision on the import request for the contained test and communicate it to the operator within a maximum of 90 days;
3. The authorization shall be valid for import into a single batch, which shall be carried out within a period of six months.
Article 17 (Import and marketing of GMOs for human and animal consumption)
1. In addition to the requirements laid down in Article 13 for the import and marketing of GMOs and their products, the tenderer shall:
A) Submit the application together with the GMO registration form and the Risk Assessment and Management Report in accordance with the provisions of Annex 4;
B) To prove legal suitability, in particular, by means of a Statute published in the Boletim da República, an updated Definitive Certificate issued by the legal registration entity, licenses and permits for import and marketing exercise in general and in particular GMOs and Certificate of Discharge and Tax Registry;
(C) ensure that it has adequate facilities and personnel with training and experience to ensure the safe handling of GMOs in accordance with this Regulation.
2. The authorization procedure shall be carried out in the light of this Regulation and the National Biosafety Authority shall issue the decision on the request for an activity within 90 days after examination and approval of the documentation.
3. The authorization shall be valid for one year and the tenderer must carry out the operation in strict compliance with the terms and conditions of authorization. 

Reference of the measure

Articles 13, 14, 15, 16 and 17 

Measure also domestic

Yes 

Products affected by the measure.

Description

Genetically Modified Organisms 

Countries/Regions affected by the measure.