The EU biosafety framework as reported by the European Commission (EC) is directly or indirectly applicable to Portugal. The EU-Regulations as referenced by the EC are directly applicable, the relevant EU-Directives have been transposed into Portuguese legislation. The portuguese Decree-law no. 72/2003, of 10th April, transposes the European Directive 2001/18/EC on the deliberate release into the environment of GMO, covering the field trials of GMOs as the placing on the market of GMOs as well as products containing or consisting of GMOs, e.g. for cultivation, import or processing into industrial products. Decree-law no. 7/2004, of 17th April, that approves the Protocol on Biosafety of the Convention on Biological Diversity. Decree-law no. 164/2004, of 3th July, that modifies the Decree-law no. 72/2003, of 10th April in accordance with Regulation no. 1829/2003 of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed and Regulation no. 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC. Decree-law no. 168/2004, of 7th July, that executes Regulation no. 1830/2003 of the European Parliament and the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC Notice no. 205/2004, of 21st December, where the Ministry of Foreign Affairs makes public that the Government of the Portuguese Republic has deposited, in 30 of September of 2004, its instrument of relative adhesion to the Cartagena Protocol on Biosafety of the Convention on Biological Diversity.Decree-law no. 36/2006, of 20th February, it assures the execution and it guarantees the fulfilment, in the national jurisprudence, of the decurrent obligations for the Portuguese State of the Regulation No 1946/2003 of the European Parliament and of the Council, of 15 July 2003, on transboundary movements of genetically modified organisms Decree-law no. 55/2015, of 17th April, concerning the contained use of genetically modified microorganisms and genetically modified organisms, with a view to protecting human health and the environment, transposing Directive No. 2009/41/EC of the European Parliament and of the Council, of 6 May 2009.

The EU framework for medical products as outlined by the report submitted by the European Commission also applies for Portugal. EU pharma legislation provides that a medicinal product may only be placed on the market in the EU if it has received a marketing authorisation, granted either by the European Commission or by a member state. As regards medicinal products containing or consisting of GMOs, the assessment for a marketing authorisation must include an environmental risk assessment in line with the requirements of Directive 2001/18/EC. As regards exports of pharmaceuticals, Regulation 1946/2003 on transboundary movements of GMOs provides that pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from its scope, thereby mirroring the provisions of the Cartagena Protocol. When the Costumes has any type of medicine at cross-border movement, and has doubts, it asks INFARMED, I.P. - - National Authority of Medicines and Health Products, I.P.. INFARMED, I.P. have not been yet asked nor have we received requests for opinions or clarifications regarding cross-border movements of GMOs. It only applies for medicinal products. If such a request is made, we check if the medicinal product in question has a Marketing Authorization (MA) in Portugal. If so, the cross-border movement is authorized and is carried out under the MA. If it does not have a MA, we assess who the importer to Portugal or the exporter from Portugal is and what is the reason for this movement. The decision to cross-border movement is made based on the reason given. If the medicinal product does not have a MA, it can only be carried out under a special permit (designated Special Authorization for Use - AUE) or for a Clinical Trial. In these cases, should be done based on the AUE or on the Clinical Trial Authorisation.

The EU legal framework specified in the report submitted by the European Commission also applies for Portugal. Regulation (EC) No 1946/2003 addresses transboundary movement of GMOs with the aim to ensure coherent implementation of the provisions of the Cartagena Protocol in the EU. It establishes rules for the transit of GMOs and for the transboundary movement of GMOs intended for contained use, in line with the provisions of the Cartagena Protocol. According to Article 13 of Regulation (EC) No 1946/2003, the exporter from the EU shall ensure notification of the transit of GMOs to Parties that have taken the decision to regulate transit of GMOs through their territory and have informed the BCH of this decision. Transit procedures through the EU are regulated by transport legislation and the Union Customs Code (Regulation (EU) No 952/2013 laying down the Union Customs Code). Notably, the transport of dangerous goods in the EU is subject to specific legislation, such as Directive 2008/68/EC on the inland transport of dangerous goods, covering transport by road, rail and inland waterways; or Regulation (EU) 2018/1139 on common rules in the field of civil aviation, which includes the safe handling of dangerous goods. Imports of GMOs to the EU for contained use must comply with the rules for contained use of GMOs. The contained use of genetically modified micro-organisms is governed by Directive 2009/41/EC, as transposed into Member States national law. Contained use of other genetically modified organisms is governed by national legislation in some Member States.

As a Member State of the EU, Portugal applies its domestic legislative framework implementing EU legislation on GMOs instead of the Protocol's advanced informed agreement (AIA) procedure. This framework is in line with the provisions of the Protocol. Please see reply to Question 13 for the description of EU and Portugal legislative measures. An operator intending to market a GMO in the EU for intentional introduction into the environment (referred to as “deliberate release into the environment” in the EU regulatory framework for GMOs) must first obtain an authorisation to this end. The authorisation for placing the GMO on the market involves all Member States, as authorised products are granted free movement throughout the territory of the EU. The so-called "notification" or "application" submitted by the interested operator must include an evaluation of potential risks to human and animal health and to the environment. It is only after a decision for authorisation is adopted based on a prior risk assessment that the operator can proceed with the release or placing on the market of the GMO in the EU. An operator who wishes to introduce GMOs into the environment for experimental purposes must first obtain written authorisation from the competent national authority of the Member State within whose territory the experimental release is to take place. The authorisation is given based on an assessment of the risks presented by the GMO for the environment and human and animal health.

Decisions for authorisation of LMOs-FFP are taken at the EU-level and applied to all Member-States, including Portugal. In this sense Portugal has no individual decisions. Please see European Commission responses on this subject. For a description of the comprehensive regulatory framework of the EU, which is applicable in Portugal, see the respective submission of the European Commission.

The relevant provisions are set in Article 20 of Directive 2001/18/EC and Articles 21 and 22 of Regulation (EC) 1829/2003.

See submission of the European Commission regarding the EU regulatory framework. Portugal has not made use of the simplified procedure for imports of LMOs as specified in Article 13 of the Cartagena Protocol.

See submission of the European Commission with regard to the respective provisions of the EU regulatory framework. The Portuguese government did not enter into any bilateral, regional or multilateral agreements. The EU has determined as per Article 14(4) and 9 (2) (c) that it relies on its existing legislative framework for intentional movements of GMOs within the European Union and for imports of GMOs into the European Union. This decision has been communicated to other Parties through the Biosafety Clearing-House.

For a description of the comprehensive regulatory framework of the EU regarding this issue see the respective submission of the European Commission. Decisions with regard to release and placing on the market of LMOs are taken on an EU level according to its regulatory framework and are binding for all EU Member States, including Portugal. This biosafety framework mandates to conduct a comprehensive risk assessment prior to decision making. Depending on the applications the risk assessments are conducted either on the national level or on the EU level.

Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures. As a member of the European Union, Portugal is obliged to ensure the enforcement of the EU Regulation 1946/2003.

As an enforcement laboratory supporting the national competent authority in implementing Article 18, the National Institute for Agricultural and Veterinary Research (INIAV) GMO laboratory has established accredited capacity for detection, identification and quantification of LMOs in official samples, primarily to verify consignments and detect the possible presence of unauthorized LMOs, as well as, to verify the national production of maize under a co-existence production system. Laboratory staff are trained and the laboratory is suitably equipped for these activities. The laboratory is accredited under ISO/IEC 17025 for LMO screening (detection), identification and quantification. In this context, method validation/verification, estimation of measurement uncertainty (for quantitative methods), routine use of positive and negative controls, participation in 4–5 proficiency tests per year, and internal/external audits are implemented. Results are reported in formats suitable for enforcement (detected/not detected; identified/not identified event name and method of reference; and mass fraction when quantification is required). A clear analytical workflow is in place (screening using 8 broad markers, followed by event-specific identification and quantification). Cases of “unknowns” (screening positive without match to known events) are managed under an internal escalation procedure through the institutional hierarchy. The laboratory is aligned with the European Network of GMO Laboratories (ENGL) and regularly participates in its Working Groups. The laboratory is not responsible of the sampling.

Portugal has designated one competent authority and focal point for the Cartagena Protocol. For further details see the respective submission of the European Commission.

The Portugal BCH focal point is regularly coordinating its activities with the national focal points from the other EU member states, with the BCH focal point of the European Community and with the SCBD Secretariat. Decisions with regard to release and placing on the market of LMOs are taken on the EU level and are binding for all EU Member States. Respective information is provided by the European Commission to the BCH and not by Member States of the EU. For further details see the respective submission of the European Commission.

For further information regarding confidential information see the respective submission report of the European Commission.

For further information regarding EU-wide implementation of Article 23 see the respective submission report of the European Commission.

For further information regarding implementation of Article 24, see the respective submission report of the European Commission, since all imports were authorised according to the EU biosafety framework.

All goods entering or leaving the European Union, via air, maritime, postal or road, are submitted to a risk analysis process in order to identify, as soon as possible, high risk shipments in several risk areas such as the area under the present questionnaire. This risk analysis is made under an EU Risk Management framework, with the help of automatic risk tools and special technics, that leads to the identification mentioned bellow and to the performance of specific controls on EU external Border. For further information regarding measures concerning illegal transboundary movement of LMOs see the respective submission report of the European Commission. Regarding the illegal transboundary movements, these involved China rice LMO, which has not been authorised in the EU and in Portugal. There were two cases reported in 2024 and two additional cases in 2025.

For further information, see the respective submission of the European Commission.

For further information, see the respective submission of the European Commission.

Decree-Law No. 147/2008 of 29 July, as amended by Decree-Laws No. 245/2009 of 22 September, 29-A / 2011 of 1 March, 60/2012 of 14 March and 13/2016 of 9 March, establishes the legal regime for liability for environmental damage and transposes, into domestic law, Directive 2004/35/EC on environmental liability with regard to prevention and remedying of environmental damage.

Portugal signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on 20 September 2011. The liability provisions of the Nagoya-Kuala Lumpur Supplementary Protocol are covered by Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of environmental damage, the Environmental Liability Directive (ELD), which establishes a framework based on the "polluter pays" principle, according to which the polluter pays and repairs when environmental damage occurs. Member States and their relevant competent authorities, which are responsible for the design and implementation of national legislation on environmental liability, are also responsible for the detailed measures laid down in article 12 of the Supplementary Protocol, which allow Parties either to apply existing domestic law or to develop new civil liability rules and procedures or to apply a combination of both. For further information see the respective submission of the European Commission.