Portugal. Agricultural Biotechnology Annual Dec. 5, 2016
Portugal is the European Union's (EU's) second largest genetically engineered corn grower, after Spain. Portugal has managed to fully implement all EU regulations in its territory, allowing cultivation but at the same time preserving farmers and consumers' choice. In the decision making process, Portugal position has evolved towards a case-by-case approach.
Disclaimer: Portugal, as a member of the European Union (EU), conforms to EU directives and regulations on biotechnology.
Section I: Executive Summary
The share of Bt corn is lower than in the previous year, most likely driven by the tight crop margins of corn caused by its low market price. Portugal has managed to fully implement all EU regulations in its territory, allowing cultivation but at the same time preserving farmers and consumers' choice. In the decision making process, The Portuguese Administration has traditionally followed a science-based approach; however, more recently the country has moved towards a case-by-case approach.
Given the country's structural shortfall of raw materials, the majority of Portuguese feed and food chain links strongly support plant biotechnology as a means of achieving higher competitiveness. Feed producers and livestock breeders defend their right to compete in equal conditions and be able to produce using the same technology as their main competitors. Portugal imports on average about three million MT of grains and about 875,000 MT of soybeans and 170,000 MT of soybean meal, as its domestic feed grain production is not large enough to meet livestock industry demand.
United States agricultural exports to Portugal consist mainly on bulk commodities, which accounted for over 50 percent of the U.S. export value in the period 2011-2015. Soybeans are the most important traded products, representing nearly one third of total Agricultural imports from the United States. The start of GE corn plantings in the United States in 1998 caused a drastic decline in U.S. corn exports to Portugal; because the EU had not yet approved these GE events (asynchronous approval). Biotechnology adoption in other grain exporting countries is having similar effects in the feedstuffs trade flows. The origin of the corn imports has changed throughout the years, with Ukraine gaining market share at the expenses of biotechnology adopters such as United States, Brazil, and Argentina.
Section II: Plant and Animal Biotechnology
Chapter 1: Plant Biotechnology
Part A: Production and Trade
a) PRODUCT DEVELOPMENT
FAS Madrid is unaware of any GE crops under development in Portugal.
b) COMMERCIAL PRODUCTION
MON810 corn has been commercially grown in Portugal since 2005 and at present Portugal is the EU's second largest producer of Bt corn, after Spain. Total area planted to corn varies every year depending on water availability, price, and competition from alternative crops.Total area planted to corn continues in decline since MY2013/14. Lower crop margins compared to alternative crops together with crop diversification established by EU's greening measures to a lesser extent, continue forcing down total corn area . On top of that, spring rains during the MY2016/17 sowing season delayed planting operations, which further reduced total corn area to historically low levels.
Further expansion of GE corn plantings in Portugal is limited by a number of factors:
- As MON810 is the only GE event approved for cultivation in the EU, the use of GE corn is restricted to those areas where corn borer represents a problem. Especially in a small crop margins scenario, only farmers facing a real threat of the pest would invest in the technology in the seed. Approvals of new traits for cultivation could raise the interest for GE crops in other areas.
- The use of corn for food purposes also limits GE corn expansion as food manufacturers continue to avoid the “Contains GMOs" wording in labels.
- The impact of corn-borer in final yields of corn intended for is smaller, hence, the use of GE corn is rather limited For instance, in the Norte region, where forage corn represents over 50 percent of the total corn area, the share of GE corn is below one percent. On the contrary, in Alentejo region, where the share of grain corn is far more representative, on average the GE corn share goes up to nearly 23 percent.
- The small average farm size that prevails throughout the country also sets a barrier for GE corn crop expansion. In other to fulfill coexistence rules, smaller farmers need to come to agreements to create GE areas. Bigger farmers can implement coexistence within their farm.
Portugal is a net importer of grains and oilseeds as the domestic production is not sufficient to meet the livestock sector demand. Exports of GE product are negligible, as the feed industry uses the production internally.
U.S. agricultural exports to Portugal consist mainly on bulk commodities, which accounted for nearly 54 percent of the U.S. exports value in the period 2006-2015, being soybeans (nearly 30 percent of total agricultural trade) the most important traded products. The expansion of GE crop production in traditional grain exporting countries has had a significant impact on trade flows to Portugal. Portugal total corn annual imports during the last 15 years were on average 1.6 million MT. The origin of the corn imports has evolved throughout the years as traditional suppliers moved towards biotechnology adoption. For instance, in the corn market, Ukraine, Serbia, and Russia have progressively increased their market quota over the years at the expenses of lower imports from the United States, Argentina, and Brazil.
Most of Portugal's imported soybeans and soybean meal are GE, with the exception of those devoted to special market niches. Soybean imports from the United States represent nearly a 25 percent share of Portuguese soybean imports.
The majority of Portuguese soybean meal imports originate from Argentina, although Paraguay has registered a significant increase in MY2015/16 as meal supplier to Portugal.Seed trade is affected by the zero tolerance of adventitious presence. The fact that the EU only allows cultivation of MON 810, serves as a trade barrier for U.S. seed exports containing or with adventitious presence of other GE events. The EU has not yet set a threshold level for adventitious GE material presence. Therefore, Portugal is forced to source its GE seeds from a limited number of origins (Chile, South Africa, Spain, and the United States to some extent).
Additionally, to some extent seed trade is affected by the GE free declarations. While Portugal, decided not to opt out from in-country biotechnology cultivation. Portugal was one of the first countries to create legislation that recognizes GE Free Zones.
Part B: Policy
a) REGULATORY FRAMEWORK
The EU Regulations directly apply in all EU member States, however, EU Directives have to be transposed into national laws, and the EU provides the opportunity for Member State governments to exercise some discretion without altering the basic scope of the EU directive.
There are two Ministerial Departments that weight-in on Portugal's biotechnology decision-making process, which are the Directorate General for Food and Veterinary Affairs (DGAV) ascribed to the Ministry of Agriculture Forestry and Rural Development and the Portuguese Agency of Environment (APA), ascribed to the Ministry of Environment.
Directorate General for Food and Veterinary Affairs (DGAV)
The Directorate General for Food and Veterinary Affairs (DGAV), within the Ministry of Agriculture, Forestry and Rural Development, is responsible for the coordination and implementation of the regulation of GE crops for cultivation as well as for coexistence monitoring and reporting. This Directorate General is also responsible for the coordination and implementation of the regulation of GE crops intended for imports and human or animal consumption and the food and feed chain control.
In addition to that, the DGAV oversees the process for registering and monitoring GE seed for planting. At present there are about 224 GE corn varieties approved for commercial cultivation in Portugal.
Portuguese Agency of Environment (APA)
The Portuguese Agency of Environment, ascribed to the Ministry of Environment, is responsible for the authorization of confined use (Decree Law 55/2015 (in Portuguese)) and deliberate release to the environment of GE products for purposes different than marketing (Decree-Law 72/2003 (in Portuguese). Decisions are based on risk assessment considering both environmental and human health potential risks after the Directorate General of Health (DGS) and the Directorate General for Food and Veterinary affairs (DGAV) weigh in. Public consultation maybe deemed appropriate.
• For imports:
Approvals of events for imports are managed at the EU level. Member States have the chance to weigh in in the approval process through their participation in the EU committees, both at the technical and political level.
• For cultivation:
Approvals of events for cultivation are managed at the EU level; however, since spring 2015, member states are entitled to “opt out" in their territories. Portugal abstained in the EU vote on renationalization of cultivation decisions in what we understand as an attempt to express their partial dislike to some aspects of the proposal. Portugal's official gazette published on April 1, 2015 Resolution 32/2015 (in Portuguese) issued by the Portuguese Republic Assembly. In this resolution, the Republic Assembly recommends to the GOP that the transposal of EU provisions on cultivation decisions is subject of Portugal Republic Assembly law.
Portugal, as with four other Member States countries that grow GE corn, decided not to opt out of GE cultivation.
Directive (EU) 2015/412 sets April 3, 2017 as limit for transposal to National Law.
c) STACKED EVENTS APPROVALS:
The procedure in place is the same for single and for stacked events.
d) FIELD TESTING
Decree-Law 72/2003 (in Portuguese) as amended by Decree-Law 164/2004 (in Portuguese), regulates the deliberate release in the environment of a GMO.Prior notice and authorization are required to carry out field tests. Those companies that intend to carry out field trials must submit a notification to the Portuguese Agency of Environment (APA) for its assessment. Risks for the environment and for human health are considered in the assessment.
The Ministerial Departments that weigh in prior to APA's opinion include the Directorate-General of Health (DGS) and the Directorate-General for Food and Veterinary Affairs (DGAV).
No field trial notifications have been recorded since 2010. An uncertain investment environment for seed companies has caused the private sector to limit their interest in the development of GE crops adapted to Portugal specific conditions. EU seed breeding companies have concentrated their efforts in non-European markets, and most of their research in plant biotechnology is conducted outside Europe. In 2016, two deliberate releases in the field of medical research have been notified to competent authorities.
a) Confined Research
Confined research with GE organisms is regulated by Decree Law 55/2015 (in Portuguese), which establishes prior notice and approval by competent authorities (APA, DGS and DGAV).
e) INNOVATIVE BIOTECHNOLOGIES
In the field of Innovative Biotechnologies, Portugal is waiting for additional guidance from the European Commission. Additional information can be found at E16013.
By Decree-Law 160/2005 (in Portuguese) Portugal regulated coexistence back in 2005 following the Commission Recommendation 2003/556/EC. Coexistence measures include observing an isolation distance that runs from 200 to 300 meters depending on whether in the adjacent plot conventional or organic crops are grown. Other options to minimize adventitious presence of GE pollen in other plots is the use of conventional corn border rows (24 to 28 rows), physical isolation, or the use of staggered plantings or staggered flowering or temporally isolation (less commonly used). Farmers must also keep conventional corn zones, also known as insect refugee areas, of at least 20 percent of the total GE corn area.
Decree-Law 160/2005 allows farmers to create GE Production Zones. In GE Production Zones farmers are still mandated to fulfill all legal obligations related to farming GE varieties, namely completing training requirements and notifying the DGAV and adjacent farmers about their GE crop farming intentions. However, and except for limit zones, farmers are exempt from applying measures to minimize the adventitious presence of GE material.
The creation of GE Production Zones, which are been increasingly used to facilitate compliance with coexistence requirements, is a good example of how small farmers can benefit from biotechnology by coming to an agreement with neighboring farms. According to 2014 data, these zones represented nearly 50 percent of the land planted to GE corn and to over 40 percent of GE corn farmers. In particular, the use of GE production Zones has contributed to facilitate the use of agricultural biotechnology.On a yearly basis, the Directorate General for Food and Veterinary (DGAV) publishes information related to coexistence measures implementation
There is no national level biotech labeling regulation developed in Portugal. Portugal, as an EU member, follows the rules set out in Regulation (EC) 1829/2003 on Genetically Modified Food and Feed, and Regulation (EC) 1830/2003 on the Traceability and Labeling of Genetically Modified Organisms. There is no “non-GMO" labeling regulation developed at the national level.
Food and feed products containing amounts above 0.9 percent per ingredient must be labeled. The large majority of feed products are labeled as “contains GE products" as opposed to food products, for which food companies have opted for reformulating in order to avoid GE products.
h) MONITORING AND TESTING
Portugal has a decentralized system for testing and controlling unauthorized presence of GMO in the feed and food chain. The Directorate General for Food and Veterinary (DGAV) is responsible for the coordination of the food and feed chain control and Regional Directorates are responsible for its implementation.
Portuguese imports are subject to random testing upon border entry, unless the EU Rapid Alert System flags a particular product and origin for additional measures. Portugal uses the Rapid Alert System for Food and Feed (RASFF) database to report food safety issues to consumers, the trade, and other member-states. In 2016 (up to November 1, 2016), no shipments were rejected due to presence of unauthorized genetically modified products in Portugal.
i) LOW LEVEL PRESENCE
As an EU member, Portugal conforms to EU directives and follows EU regulations on agricultural biotechnology. Since July 2011, EU legislation sets a 0.1 percent3 technical zero' level for shipments devoted to the feed market.
However, for products that will enter the food chain the tolerance is absolute zero. Consequently, adventitious presence continues to be a concern for traders, who carry out a no-risk policy in their purchases, regardless the final use.
The absence of a threshold limit for GE material in seeds results in trade disruptions. Because the EU-28 only allows cultivation of MON 810, it serves as a trade barrier for U.S. seed exports containing or with adventitious presence of other GE events. Seed companies operating in Portugal are forced to source its GE corn seeds from a limited number of origins such as Chile, South Africa, Spain, and to some extent the United States.
j) ADDITIONAL REQUIREMENTS
• Mandatory Training:
Those farmers who want to cultivate GE crops in Portugal must participate in mandatory training sessions provided by the seed companies. The content of the training sessions is established by the DGAV and includes information about the national and EU regulations in regards to GE crops.
During these training sessions, the national regulation on GE corn is explained. In 2015, 51 farmers participated in these training sessions. GE corn seed lots are marketed accompanied by leaflets containing information regarding coexistence, traceability, and labeling.
• GE Crops Field Register
Farmers who want to grow GE crops must complete mandatory training and submit a completed notification form to DGAV 20 days before planting. In 2015, there were 216 notifications down from the 238 notifications registered in 2014. The large majority of the notifications (52 percent) corresponded to the Alentejo Region. Producers must also communicate any alteration of the planting plan to the Regional Directorate for Agriculture.
Farmers must communicate to neighboring farmers their intention to plant GE corn, and the plots within distances established in Decree-Law 160/2005 (in Portuguese).
Farmers must put in place measures to avoid adventitious presence in neighboring fields and comply with traceability and labeling requirements as well as facilitate official control by competent authorities in their farms.
k) INTELLECTUAL PROPERTY RIGHTS (IPR)
The Community Plant Variety Right (CPVR), issued by the Community Plant Variety Office (CPVO) in Angers, (France), provides intellectual property rights for protection of plant varieties. However, the European Patent Convention (EPC) of October 1973 excludes patents for plant varieties. The CPVR enables breeders to be granted a single intellectual property right operative across the EU. The CPVR coexists with individual Member States' national plant protection legislation as an alternative form of protection.
Portugal has its own Plant Varieties Protection System. Plant Varieties Protection Rights in Portugal are regulated by Decree – Law 213/1990 and Portaria 940/1900 (in Portuguese).
The registration in the Protected Plant Varieties Catalog is voluntary and managed by CENARVE (National Center for Protected Varieties Register). Registration provides seed breeders' with a 15 – 20 years protection period for annual or permanent crops respectively.MON810 is the only GE event commercially grown in Portugal. As with most of the corn cultivated in Portugal, MON810 is also a hybrid. As a result, IPR is not an issue for Portugal's GE crops since hybrid seeds are not replanted.
l) CARTAGENA PROTOCOL RATIFICATION
The EU is a signatory to the Cartagena's Biosafety Protocol, as is Portugal. Portugal became a party to the Protocol in 2004 (Decreto 7/2004 (in Portuguese)).
m) INTERNATIONAL TREATIES AND FORA
Portugal's participation in international treaties and fora is not different from that of the EU.
n) RELATED ISSUES
Portugal was one of the first countries to create legislation that recognizes the right of farmers to voluntarily associate and establish both GE Production Zones and GE Free Zones. The initiative to create a GE Free Zone as defined in Portaria 904/2006 (in Portuguese), and amended by Portaria nº 1611/2007(in Portuguese), initiates with the farmers or from the Municipal Administration. In the latter case, farmers are still required to express their opinion and the process will only advance if farmers give their public consent. The right for an individual farm to be excluded from the free zone is safeguarded.
Autonomous Region of Madeira
By the publication of Regional Legislative Decree 15/2010M (in Portuguese) in 2010, the Autonomous Region of Madeira became the first Region of the EU to declare itself a zone free of the cultivation of genetically modified organisms. Although EFSA concluded that no new scientific evidence would justify a prohibition of the cultivation of GE plants in Madeira, as the Commission's deadline expired, the Portuguese Decree was tacitly accepted.
Autonomous Region of the Azores
Regional Legislative Decree 28/2012/A (in Portuguese) published in June 2012 prohibits the cultivation of GE crops for commercial purposes in the Azores, as allegedly the Region's environmental quality and biodiversity wealth would be endangered by the cultivation of GE crops.
Part C: Marketing
a) PUBLIC/PRIVATE OPINIONS
The Portuguese Administration has traditionally followed a science-based approach in the biotech decision making process and has fully implemented all EU regulations in its territory, including strict coexistence rules. Until 2015, Portugal had always followed EFSA's advice when voting. However, more recently the country has moved towards a case-by-case approach in the decision making process.
Portugal is the second largest producer of GE crops in the EU after Spain, which demonstrates the strong support by most farmers. Portugal is an importer of corn feed products and protein crops like soybeans. Given the needs of the animal production sector, the majority of Portuguese feed and food chain links strongly support plant biotechnology as a means of achieving higher competitiveness. Feed producers and livestock breeders defend their right to compete in equal conditions and be able to produce using the same technology as their main competitors.
There is not a strong reaction from meat retailers or consumers.
b) MARKET ACCEPTANCE/ MARKETING STUDIES
In Portugal, as in other European countries, GE products are primarily used for feed purposes. The presence of GE labeled consumer oriented products is inexistent, as the large majority of food manufacturers eliminated GE products from the composition to avoid labeling as “Contains GMOs."
However, feed producers and livestock breeders defend their right to compete in equal conditions and be able to produce using the same technology as their main competitors.
Biotechnology Information Center (CIB) is a non-profit organization supported by different public and private institutions. Created in 2002, CIB's main goal is to promote communication on biotechnology in Portugal as well as in other Portuguese speaking countries. CIB shares information, engages in public debates consults in biotechnology related regulation development. It also organizes seminars targeting different audiences.
There are not many recent country-specific studies on marketing or acceptance of biotechnology in Portugal. A study entitled “Challenges facing European agriculture and possible biotechnological solutions" and published in July 2015 identifies and analyzes agricultural challenges for nine major crops (including corn) in 13 EU countries (including Portugal). The study examines how this challenges are addressed by public and private research sectors, using either conventional breeding, marker-assisted selection, transgenesis, cisgenesis, RNAi technology or mutagenesis. This study found that for the nine major crops in Europe, 40 percent of the challenges identified were addressed neither in the scientific literature nor in recent European public research programs. The private sector was addressing only a few of these “neglected" challenges confirming the considerable gap between farmer's needs and current breeding and biotechnology research. This study concludes that the current political situation in certain EU countries is an impediment to GE research in order to address these agricultural challenges in the future.
Chapter 2: Animal Biotechnology
Part D: Production and Trade
a) PRODUCT DEVELOPMENT
FAS Madrid is not aware of any genetic engineering or cloning of farm livestock carried out in Portugal.
b) COMMERCIAL PRODUCTION
There are neither GE animals nor cloned animals commercially used in Portugal. There is no production of GE animals or clones intended for the food market in Portugal.
Portugal does not have a system to monitor the imports of GE animals and cloned offspring or genetics from clones. Not applicable.
e) TRADE BARRIERS
At the moment there are no known trade barriers related to GE or cloned animals.
Part E: Policy
a) REGULATORY FRAMEWORK
b) INNOVATIVE BIOTECHNOLOGIES
Portugal has not regulated the use of innovative biotechnologies in animals.
c) LABELING AND TRACEABILITY
Portugal has implemented EU legislation on labeling and traceability.
d) INTELLECTUAL PROPERTY RIGHTS (IPR):
Portugal has implemented EU legislation.
e) INTERNATIONAL TREATIES/FORA
Portugal's participation in international treaties and fora is no different from that of the EU.
f) RELATED ISSUES
Part F: Marketing
a) PUBLIC/PRIVATE OPINIONS
b) MARKET ACCEPTANCE/ STUDIES