Highlights

Since 2006 Poland has been one of the biggest opponents of the use of Genetically Modified Plants (GMO). Polish law prohibits marketing and cultivation of “GMO" plants or products. On January 1, 2017, a ban on the import of such feed is scheduled to enter into force. Originally this ban was to apply in 2008, but was delayed first until 2013 then again until 2017 due to strong opposition from Poland's livestock industry.

Section I. Executive Summary:

Poland is a major agricultural producer within the new European Union Member States. Poland adheres to the standards adopted in Community law. While a majority of Polish scientist and commercial farmers are open to newer technologies, the subject of agricultural biotechnology has become much politicized in Poland. Studies conducted between 2000 and 2012 indicate that 70 percent of the society is against application of agricultural biotechnology in Poland. Studies also confirm the fact that average citizen's knowledge about biotechnology in Poland is very limited. Polish environmental activists and consumer groups are actively protesting against the use of biotechnology in agriculture.

On February 6, 2014, Polish President signed an amendment to the Act on genetically modified organisms introducing stricter rules to ensure greater safety associated with the cultivation and use of genetically modified organisms in the laboratories. Since June 2015, working regulations necessary to implement these regulations are going through public comment period.

As of January 28, 2013, the Polish government banned the cultivation of EU-approved genetically engineered (GE) Mon-810 maize and the Amflora potato through an amendment to the separate Polish Seed Act. Poland's Feed Act of 22 July 2006 (OJ 2006 No. 144, item.1045) includes prohibition on the manufacture, marketing and use in animal nutrition genetically modified feed and genetically modified organisms intended for feed use. In practice the ban has been suspended by the Polish Parliament until January 1st, 2017. On November 4, 2016, the Parliament voted in favor of the Act, but modified the prolongation of the ban's suspension until January 1st, 2019. Given current market conditions and public perception, besides the existing feed market for soybeans, the prospect for developing the Polish market for GE crops and food is limited. Poland remains a major consumer of GE feed ingredients and on average annually imports more than 1.8 million metric tons of soybeans and soy meal and corn for the livestock sector.

Currently, the topic of GE animals is not part of Poland's political agenda. Media coverage and public awareness on the subject is low. GE animals are used only for medical research purposes.

CHAPTER 1: PLANT BIOTECHNOLOGY

PART A: PRODUCTION AND TRADE

a) Product Development

There are no GE crops under commercial production in Poland. Several research institutions are conducting research projects under confined conditions. These research programs consist of basic research, plant breeding (in few cases in cooperation with foreign companies or laboratories), and experiments gauging the influence of GE plant varieties on the environment.

b) Commercial Production

Since 2011 Poland's Parliament (the Sejm) has been conducting a debate on a new, very restrictive legislative proposal pertaining to agricultural biotechnology. On January 28, 2013, the ban on cultivation of GE crops entered into force along with the amended Law of the Seed (Seed Act). Obligatory measures were implemented into Polish law, which is a significantly burden thus discourages farmers interested in planting GE crops on a commercial scale. The Ministry of Agriculture (MOAg) drafted regulations containing coexistence requirements that call for isolation zones between GE crops and conventional and organic crops of 500 and 1,000 meters, respectively.

c) Exports

Not applicable.

d) Imports

Poland imports feeds enhanced through biotechnology. According to Poland's Feed Act of 22 July 2006 (OJ 2006 No. 144, item.1045), this kind of import is banned. In practice the ban has been suspended by the Polish Parliament many times, the last time until January 1st, 2019. Originally, this ban was to apply in 2008, but was delayed first until 2013 then again until 2017 due to strong opposition from Poland's livestock industry. Annually Poland imports an estimated 1.8 thousand metric tons (MT) of animal feed with GE content. Imports originate from Argentina and Brazil (transshipped through Germany and The Netherlands) and the United States.

Current legislation prohibits planting of GE crops. Effective 28 January 2013 the amended Seed Act entered into force. Concurrently the MOAg began regulating cultivation of the two EU-approved GE events. The MOAg based its cultivation restriction on authorities defined under Article104, paragraph 9 of the amended Seed Act.

e) Food Aid Recipient Countries

Poland is not a food aid recipient, consequently faces no issues related to biotechnology that would impede the importation of food aid donations. Poland is traditionally a cash donor.

Part B: POLICY

a) Regulatory Framework

The June 22, 2001 law on “Genetically Modified Organisms" (O.J. 2007, No 36, pos.233, 2009n No 18 pos. 97, 2015 pos. 277) is the basis for the current regulation applicable to GE products/research.

The Act regulates:

• the contained use of GM organisms;

• deliberate release of “GMOs" into the environment;

• introducing “GMO" products in to the market.

The Act harmonizes Polish law with European Union law. It stablishes background for The National Strategy for the Biological Security. The Strategy was developed in the Institute of Plant Breeding and Acclimatization in 2005.

Ministry of Environment (MOE) is the competent authority handling the notification and regulation of agricultural biotechnology use in Poland. The MOE is advised by the Polish Commission for the use of GE Products, an expert advisory body consisting of scientists, representatives from administrative authorities and non-governmental organizations. MOE cooperates with the Ministry of Health (MOH) regarding address of potential risks to human health. The MOE is the Competent Authority in reference to the Cartagena Protocol on Biosafety.The Ministry of Agriculture (MOA) is responsible for animal health, crops, feeds, and agricultural risks associated with biotechnology. The MOA is the Competent Authority in reference to food and feed enhanced through biotechnology and on rules for co-existence.

On June 1, 2011, the Parliament passed the revised National Seeds Law with restrictive language prohibiting distribution of GE seeds (officially banned for commercial trade since 2006). On January 2, 2013, the Polish Council of Ministers, at the request of the Minister of Agriculture, re-authorized its 2008 framework position on biotechnology. With re-authorization of the government policy and under the auspices of the EU safeguard clause, the MOA regulated cultivation of GE crops effective January 28. On January 28, 2013, the ban on cultivation of GE crops entered into force along with the amended Law of the Seed.

On June 20, 2013, the European Commission took Poland to the EU Court of Justice for failure to comply with the EU principles of monitoring of GE crops, including registry location of such crops. The Polish President vetoed the new seeds law passed by the Parliament; in part on grounds the proposed legislation would prohibit registration of genetically-engineered seed in the national registry, a requisite for commercial cultivation in Poland and in part the legislation would not bring Poland into compliance with the findings of the European Court of Justice.

On February 6, 2014, the Polish President signed an amendment to the Act on genetically modified organisms introducing stricter rules to ensure greater safety associated with the cultivation and use of genetically modified organisms in the laboratories. There are a lot of sectoral Acts and regulations on “GMO" legislation in Poland; except the basic Law on Genetically Modified Organisms. Sectoral laws are essential for the functioning of “GMOs" in Poland. The following Acts are the most important within the system of biosafety in Poland:

• The Act of 22 July 2006, on Feed (OJ 2006 No. 144, item. 1045), with later amendments - it introduces to the Polish law the provisions of EU regulations and implements the EU directives, regulates the production and use of medicated feed and marketing, as well as the requirements of quality and hygiene of feed and placing them in the market. It regulates supervision and official control of feed.

• The Act of 25 August 2006, On Food Safety and Nutrition and amendments. The Act defines, among others, health requirements of food, requirements for compliance with the principles of food hygiene, materials and articles intended to come into contact with food and the competences of authorities and basic procedures and requirements of official food controls.

• Act of 9 November 2012, Seed (OJ 2012 pos. 1512), and amendments. The Act regulates the issues related to the examination and assessment of varieties for registration, record keeping crop varieties and production, trade, assessment and control of seed.

Regulations to the Seed Law are as follows:

• Council of Ministers of 2 January 2013. On the prohibition of seed potato Amflora (OJ 2013 pos. 27).

• Council of Ministers of 2 January 2013. On the Prohibition of Seed Maize MON 810 (OJ 2013 pos. 39)

• Council of Ministers of 8 May 2013. Amending the Regulation on the Prohibition of Seed Maize MON 810 (OJ 2013 pos. 590)

• Council of Ministers of 30 April 2014. Amending the regulation on the prohibition of seed maize MON 810 (OJ 2014 pos. 641)

On 18 November 2008 the Council of Ministers adopted the Framework Poland's Position on Genetically Modified Organisms. The Government's position is negative in relation to the placing in the market of the EU Community of GM organisms, GM food and feed. The Government opposes marketing of products under Directive 2001/18 / EC. It is against the authorization of “GMOs" for cultivation and release of “GMOs" into the environment for experimental purposes. It is recognized, however, as reasonable to perform experiments aimed at obtaining results on agri-environmental impact of genetically modified organisms on the environment in the Polish climatic conditions, carried out by research institutions and universities.

b) Approvals

For information regarding bioengineered crops approved for cultivation, food or feed use in the EU. On January 28, 2013, the ban on cultivation of GE crops entered into force in Poland along with the amended Law of the Seed (a number of Member States have invoked the so-called 'safeguard clause' of the previous EU Directive 90/220/EEC. This clause is also included in Directive 2001/18/EC, which replaced Directive 90/220/EEC. This safeguard clause provides that where a Member State has justifiable reasons to consider that a “GMO," which has received written consent for placing on the market, constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the use and/or sale of that product on its territory.)

c) Field-Testing

In 2015, two GE plants were undergoing field tests in Poland: poplars and flax.

d) Stacked Event Approvals

Poland implements EU legislation regarding stacked events.

e) Additional Requirements

There are no additional requirements.

f) Coexistence

The Polish Ministry of Agriculture has draft coexistence implementing regulations that call for isolation zones between GE crops and their conventional and organic crops of 500 and 1,000 meters, respectively. As of December 2016 legislation on co-existence of geetically modified crops with conventional and organic farming is continues to be under development. 16 Polish regions have passed declaration as GMO free. No official statement regarding the possible implementation date has been issued by the Polish Government.

g) Labeling

Packaged foods and feeds derived from and/or containing GE enhanced ingredients must be labeled.

“Contains GMOs" is a typical example of a product label statement found on the Polish market.

Labeling is enforced by local authorities and follows EU labeling standards.

h) Trade Barriers

Currently there are no trade restrictions on U.S. products at the national level. The European anti-biotech climate remains the major trade constraint for GE products.

i) Intellectual Property Rights

Poland adheres to EU legislation.

j) Cartagena Protocol Ratification

Poland – date of ratification: December 10, 2003.

k) International Treaties/Fora

Poland has not taken any significant position in international fora, e.g. at the Codex Alimentarius. The MOAg and MOE are openly opposed to GE plants and products. On January 2, 2013, the Polish Council of Ministers, at the request of the MOAg, re-authorized its 2008 framework position on biotechnology and permitted the Ministry to ban cultivation of GE crops by applying the EU safeguard clause. This position is being popularized during many international meetings of Agricultural decision makers.

l) Related Issues

While Polish scientists are interested in New Breeding Technologies (zinc fingers, site directed mutagenesis, etc.,) Polish authorities are rather hesitant in their adoption. Reportedly even research studies on (EU approved) GE plants are not granted permission to be conducted lately.

m) Monitoring and Testing

The Ministry of Agriculture (MOAg) is responsible for animal health, crops, feeds, and agricultural risks associated with biotechnology. The MOA is the Competent Authority in reference to food and feed enhanced through biotechnology and on rules for co-existence. Campaign was followed by MOAg field and laboratory inspections (nine thousand test conducted), which confirmed successful implementation of “GMO" cultivation ban in Poland.

n) Low Level Presence Policy

Low-Level Presence Policy: Poland has been open to imports of commodities holding a low-level presence of bioengineered events in general. Despite its official anti-GE position, at the EU level Poland supports resolution of the issue.

Part C: MARKETING

a) Market Acceptance

As of January 2013, Poland enforced a ban on cultivation of GE crops. Recent retail studies show that purchase decisions of the majority of Polish customers are determined by price of the product – versus its ingredient list. Further promotional media campaigns included: “GMO" free mozzarella like cheese from Zott company. Poultry producer Drosed promotes its products as “GMO" free.

b) Public/Private Opinions

Nearly70 percent of the Polish population is against usage or cultivation of GE crops and products. Studies also reveal that level of knowledge in Poland about GE plants and products is very shallow. Anti-GE organizations active in Poland include: Greenpeace, International Coalition to Protect the Polish Countryside, Stop “GMO," Friends of the Polish Countryside, The Greens/European Free Alliance in the European Parliament, Friends of the Earth, Association of Ecological Farmers. All groups are very vocal and employ Polish celebrities in order to attract media coverage. Consistent with their marketing strategy in other countries, their scripts are based on innuendos, not verified studies or actual results of the technologies use in other countries.

c) Marketing Studies

Polls conducted in Poland in 2012 show that nearly 70 percent of respondents were against buying/eating food derived from GE crops. Usage of feeds containing GE content is not being questioned, mostly due to lack of awareness.

Chapter 2: ANIMAL BIOTECHNOLOGY

Cloning is an animal biotechnology that developers frequently utilize in conjunction with other animal biotechnologies such as genetic engineering.

Part E: PRODUCTION AND TRADE

a) Biotechnology Product Development

In Poland GE animals are used for basic research and pharmaceutical studies, but as in any EU country it is not allowed to use GE animals for food. Research on GE animals is very limited. Three research centers in Poland: Institute of Animal Breeding in Balice (Krakow), Institute of Animal Genetics in Jastrzebiec (Warsaw) and Agricultural University (Poznan) conduct such research. Each research project must be approved by the MOE.

The main objectives of research on GE animals are:

- Use in the production of proteins, enzymes and other substances in the pharmaceutical industry;

- Immunization of livestock for diseases;

- Increase productivity and efficiency of animals and thus obtain the desired animals traits for breeding;

- Production of material for xenotransplantation. This technology uses cloning for multiplication of animals with organs used for transplantations. It is the only use of animal cloning currently implemented apart from research projects.

b) Commercial Production

In Poland GE animals are used for basic research and pharmaceutical studies. Likewise, there are no commercial applications of animal cloning.

c) Biotechnology Exports

N/A

d) Biotechnology Imports

N/A

Part F: POLICY

a) Regulation

Legislation on GE animals is based on the Polish Law on “Genetically Modified Organisms" dated June 22, 2001 (updated May 21, 2003). This legislation mainly addresses GE plants. There is no legislation regarding cloning of animals. The Sejm is working on a new biotechnology law. The MOE is responsible for oversight of existing biotechnology regulations. The MOH is responsible for regulation of food originating from GE animals. These foods are considered “novel foods."

There are no regulations in Poland which are specific to GE animals. Biotechnology in general in Poland remains a very political issue.

b) Labeling and Traceability

Poland has been following the EU regulations in this area; there is no national policy in place.

c) Trade Barriers

Main trade barrier remains the EU policy.

d) Intellectual Property Rights

N/A

e) International Treaties/Fora

N/A

Part G: MARKETING

a) Market Acceptance

N/A

b) Public/Private Opinions

So far, there haven't been significant discussions on the topic that would divide the general public into distinctive opinion groups.

c) Market Studies

FAS Warsaw is not aware of any market studies or activities related to animal biotechnology and GE animals.