Brussels, Belgium
May 29, 2015
Source: EuropeBio
Summary
In order to contribute to a competitive and sustainable Europe, a functioning evidence-based EU policy on GMOs
is needed. Such a policy requires:
- the EU-wide authorisation of safe products,
- adherence to and implementation of the EU’s existing established timelines as prescribed by laws,
- regulatory workability and predictability,
- an enabling regulatory environment and legal certainty,
- trade facilitating measures and
- additional risk communication to build trust
None of the above requirements are currently completely fulfilled. To fulfil them, it is simply necessary to apply
and implement the existing EU legislation properly and improve legal certainty. Jointly, we believe that failing
to support the EU’s own best science is the single most damaging element for growth, innovation, investment as
well as consumer confidence and safety. Like all industries and supply chains, we require and demand a
reasonable level of legal and regulatory certainty. The Commission proposal to nationalize GM imports puts
the whole set of principal requirements outlined above at risk. We therefore firmly and principally reject this policy
approach.
The Food and Feed Chain Coalition (FFC) represents different parts of the food and feed chain whose members
are directly impacted by EU policies related to Genetically Modified Organisms (GMOs). We fully agree with
President Juncker that “Jobs, growth and investment will only return to Europe if we create the right regulatory
environment and promote a climate of entrepreneurship and job creation. We must not stifle innovation and
competitiveness with too prescriptive and too detailed regulations (…)”. This is also and especially true for
agriculture and the food and feed chain. The EU’s stance on agricultural biotechnology is one of the most striking
examples of the EU stifling innovation and competitiveness.
Agricultural biotechnology for feed and food production has been taken up rapidly by farmers in many parts of the world where they are given the choice and GM crops have become an important element in global food and feed supplies. Without a functioning and evidence-based EU policy on GMOs, the development and availability of innovative products for farmers as well as balance of the EU’s supply for food and feed uses is threatened and the reliability of the European food and feed chain is undermined. This translates into considerable additional commercial and legal risks for operators, higher costs for supplies and trade disruptions1. Furthermore, the precedent of allowing short term political considerations to take priority over scientific evidence represents one of the biggest disincentives for high technology sectors to invest in the EU.
A functioning evidence-based EU policy on GMOs would require:
1. EU-wide authorisation of safe products
Any product authorisation system is only functional if it leads to the authorisation of safe products. Scientific safety evaluations should not be overruled by considerations related to other, such as socio/economical, factors and therefore leading to non-science based decisions.
- EU status: All GM products on the market have been proven to be as safe as conventionally bred crops. Despite this, GMO authorisations in the EU are regularly being unduly delayed or blocked.
- Required Action:
- The Commission must ensure efficient and diligent decision-making on safety assessed applications as legally required.
- Member States should vote in accordance with the scientific evidence on product safety. Those that continue to vote against or abstain on the authorisation of safe products should be required to state their real reasons for doing so (which are usually not related to product safety). Their voting behaviour harms innovation and jobs, perpetuates unfounded prejudices about the technology and undermines public trust in the EU regulatory processes.
2. Adherence to and implementation of the EU’s existing laws
Public Institutions are required to follow and implement democratically agreed legislation.
- EU Status: On paper, the EU’s primary legislative framework on GMOs is demanding but solid. In practice, the existing and democratically agreed EU law has routinely been broken by the EU Commission and several Member States2.
- Required Actions:
- The Commission must ensure the proper functioning of the EU authorisation system leading to decisions on GM authorisations driven by science-based considerations and in accordance with the timelines prescribed by EU law3.
- Member States must be forced to lift scientifically untenable and legally questionable cultivation and import bans.
- The Commission must stop referring safety assessed products back to EFSA for unfounded reasons and avoid potential discrimination between safety assessed products.
3. Regulatory Workability and Predictability
It is a legitimate expectation of applicants and operators to know how to comply with regulatory requirements.
- EU Status: Most recently, it has taken the EU Commission more than 1 year to authorise 17 pending applications, The EU authorisation system for GMOs must not allow for such unsubstantiated delays in meeting regulatory timelines to prevent new backlogs of dossiers for both EU import and cultivation authorisations.
- Required Actions:
- Risk assessment (on GMOs as on other products) should be practical, effective and efficient, and its complexity should be commensurate with the level of risk.
- Implementing regulation 503/2013 should be revoked or amended as it enshrines an approach to stacked events which is not commensurate with the level of risk and poses a high unnecessary burden on the regulatory system and international trade. It introduces political demands in the risk assessment requirements which go against scientific evidence and against the will of the risk assessor.
4. Enabling regulatory environment and legal Certainty
Despite continuous requests from operators as well as Member States, the EU still lacks an enabling regulatory environment for the use of GMOs in EU agriculture and food and feed production. The problem of an unintentional and unavoidable presence of traces of GMOs in non-GM products continues to present a serious and long-lasting threat to plant breeders, farmers and all operators involved in the processing of home grown or imported agricultural raw materials for food and feed use in the EU. This puts the EU food and feed chain at a competitive disadvantage globally, increasing the cost of seeds, farm production and food and drink industry inputs.
- EU Status: Without a practical minimum required performance limit and a defined uniform approach for sampling and testing for food and seed, there is no legal certainty when it comes to implementing the EU zero tolerance policy as regards non-authorised GMOs. There is also no appropriate legal framework when it comes to traces of authorised GM seeds in non-GM seeds.
- Required Actions:
- The Commission should extend the existing “technical solution” (which has provided an interpretation of zero for not yet approved GMOs and introduced harmonized rules for sampling and testing) for feed to food and seed to grant legal certainty to all operators.
- The Commission should propose practical labelling thresholds for the adventitious presence of GM seed in non-GM seed, similar to food and feed products (Regulation 1829/2003)5.
5. Trade facilitating measures
The EU plays a key role in the world as a leading exporter and importer of seed and agricultural commodities. The EU should therefore develop trade facilitating measures.
- EU Status: The increasing a-synchronicity of authorisations, combined with the EU’s zero tolerance policy to traces of GMOs not (yet) EU approved even when they are found safe by third countries and EFSA, has led to unnecessary trade disruptions, legal uncertainty and higher costs.
- Required Actions:
- Approve pending and upcoming import dossiers which have been deemed safe by EFSA.
- Streamline the EU authorisation process to reduce the a-synchronicity6.
- The EU should engage in ongoing international cooperations to find sustainable solutions to the “low level presence” of safety-assessed but not yet EU-authorised GMOs.
- The EU must stop deviating from internationally agreed standards but rather deepen its regulatory cooperation with its trading partners to reduce unnecessary duplications and burdens for operators and taxpayers.
6. Risk Communication to build Trust
We are convinced that public authorities responsible for the authorisation of products assessed as safe also have a responsibility to communicate about this product safety – especially when unfounded concerns persist.
- EU Status: There is no doubt about the safety of risk assessed GMOs, as confirmed by EFSA’s product specific scientific opinions, numerous studies conducted by the European Commission and Member State Authorities, using significant amounts of taxpayers’ money. The most trusted and representative scientific institutions such as the European Academies Science Advisory Council concur with the assessment that GMOs are at least as safe as conventional crops.
- Required Actions:
- Public institutions at EU and Member State level should provide transparent, clear and easily accessible information about GMO product safety.
- Even more importantly, public institutions should stop fuelling unfounded concerns by delaying or blocking the approval of safe products and by banning EU approved safe products.
Before this background, the FFC is of the opinion that the Commission’s policy approach to nationalise authorisation decisions for GM cultivation (as already adopted) as well as for GM imports (as recently proposed) should be rejected as it fails to deliver on any of the concerns and needs of the European food and feed chain operators.
A proper implementation needed
- The Commission should focus on a better implementation of the system providing legal certainty for operators instead of allowing Member States to renationalise the use of GMOs despite EU authorisation based on scientific grounds.
- Only a workable and legally sound system can generate benefits for economic operators and consumers.
Internal market
- The Internal Market defined as “an area without internal frontiers” is the backbone of the European economy. The EU must ensure the effective functioning of the single market which will enable an effective trade policy. The use of GMOs should remain regulated at Union level to preserve the internal market.
Trade policy
- World trade is a pillar of the EU economy. Trade distortions, created by unjustifiable restrictions on the use of GM plants in violation of the EU Commitments under the WTO and SPS agreements, must be rejected.
Jobs and Growth
- In order to boost jobs and growth in the framework of the smart regulation agenda, it is vital to avoid any restrictions of free movement and use of products within the internal market.
- A potential move towards nationalisation would have huge socio-economic impact and negative consequences for all EU agri food chain partners. This situation would lead to significant job losses and lower investment in agri-food chain activities in countries which would restrict or prohibit the use of GMOs or GM food and feed. EU’s competitiveness and growth prospects cannot be put at risk by a nationalisation proposal.
1 According to studies on behalf the European Commission, the total cost to the economy would be € 9.6 billion.
2 Examples include the Commission’s regular undue delay when putting products to the Member State vote (as admitted in its reply to parliamentary question E-004184/2012), the Commission’s entire failure to do so, the Commission’s repeated request for additional EFSA opinions on the same products “in a dilatory manner” (both as ruled by the General Court in its judgment of 26 September 2013 on case T-164/10) , and in the numerous safeguard clauses on cultivation and import, which are maintained or renewed despite regular EFSA rejections of the new “scientific evidence” presented, and even despite rulings by EU and national courts declaring some of these bans illegal.
3 The Commission highlighted this legal obligation in its reply to Parliamentary question E-2014-011172
4 In its reply to Parliamentary Question E-008611/2013, the Commission stated that it “will continue, as in the recent past, to pay particular attention to authorisations which can have major impact on trade”.
5 The Commission explained the need for a threshold in a 2003 memo and Council asked for it in 2006 and 2008.
6 The Commission stated its intention to “reduce the asynchronicity of authorisations between the EU and exporting third countries” in its reply to Parliamentary Question E-006082/201
a.v.e.c. is since 1966 representing and promoting the interests of the European poultry meat sector. Members are national organisations representing poultry processors and the poultry trade in 16 EU countries with about 95% of the EU poultry meat production. The European poultry meat business employs more than 300 000 citizens and has a turnover of more than 32 billion Euros.
COCERAL is the European association of cereals, rice, feedstuffs oilseeds, olive oil, oils and fats and agrosupply trade. It represents the interest of the European collectors, traders, importers, exporters and port silo storekeepers of the above mentioned agricultural products. COCERAL’s full members are 26 national associations in 18 countries, and 1 European association [Unistock]. With about 2500 companies as part of COCERAL national members, the sector trades agricultural raw materials destined to the supply of the food and feed chains, as well as for technical and energy uses.
Copa-Cogeca is the united voice of farmers and agri-cooperatives in the EU. Together, they ensure that EU agriculture is sustainable, innovative and competitive, guaranteeing food security to half a billion people throughout Europe. Copa represents over 23 million farmers and their families whilst Cogeca represents the interests of 22,000 agricultural cooperatives. They have 66 member organisations from the EU member states.
ESA European Seed Association is the voice of the European seed sector, representing those active in research, breeding, production and marketing of seeds. Its membership consists of more 36 national seed associations, representing more than 7000 seed businesses, and of more than 60 individual company members.
EuropaBio is the European Association of BioIndustries. Our members are involved in research, development, testing, manufacturing and commercialisation of biotech products and processes in human and animal healthcare, diagnostics, bioinformatics, chemicals, crop protection, agriculture, food and environmental products and services. EuropaBio also counts a number of National Biotech Associations in its membership who in turn represent more than 1800 biotech SMEs.
The European Flour Millers’ association is the voice of the European flour milling industry. It gathers the national associations from 28 European countries. They represent 3 800 companies employing some 45 000 people. With some 45 million t of agricultural commodities processed in the EU each year, the sector is the largest single food user of EU domestic wheat, rye and oats.
EUVEPRO is the European Vegetable Protein Federation representing the interest of the producers of vegetable proteins for human consumption in the EU.
FEDIOL, the EU vegetable oil and proteinmeal industry association, represents the interests of the European seed and bean crushers, meal producers, vegetable oils producers, refiners and bottlers. FEDIOL’s members are 12 national associations and associated company members in 5 other EU countries. With about 150 facilities in Europe the sector provides 20.000 direct employments. Its members process approximately 36 million tonnes of basic products a year, both of EU origin and imported from third country markets.
FEFAC is the European Compound Feed Manufacturers’ Federation. FEFAC represents 24 national Associations in 23 EU Member States as well as Associations in Switzerland, Turkey, Croatia, Serbia, Russia and Norway with observer/associate member status, and is the only independent spokesman of the European Compound Feed Industry at the level of the European Institutions. The European compound feed industry employs over 110,000 persons on app. 4,000 production sites often in rural areas, which offer few employment opportunities.
The Federation of European Rice Millers is the voice of the European rice milling industry. FERM is made up of 21 company members from around Europe as well as 3 national rice milling associations of Italy, Spain and Portugal. In representing over 90% of the milling capacity in Europe it is able to reflect credibly and authoritatively the interests of the industry.
FoodDrinkEurope represents the European food and drink industry, the largest manufacturing sector in the EU in terms of turnover and employment. It aims to promote the industry's interests to European and international institutions, contributing to a framework addressing, inter alia, food safety and science, nutrition and health, environmental sustainability and competitiveness.
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The European Livestock and Meat Trades Union (UECBV) represents national federations of livestock traders, meat industry, and meat traders. Through its 52 national member federations, UECBV is the voice for some 20,000 trading and industrial companies.
Unistock Europe is the only European association of professional storekeepers for agribulk commodities in the European Union. Unistock Europe full members are present in 11 countries. With a total of approximately 79 port silos facilities Unistock Europe proactively represents the united voice for the agri-bulk storage sector towards the EU authorities. Unistock Europe is a full member of COCERAL.
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