FAILURES OF THE EU AUTHORISATION SYSTEM FOR GMOS - CAUSES, IMPACTS AND SOLUTIONS - UPDATE MARCH 2013

Transcription

1 FAILURES OF THE EU AUTHORISATION SYSTEM FOR GMOS - CAUSES, IMPACTS AND SOLUTIONS - UPDATE MARCH 2013 EXECUTIVE SUMMARY 1. The EU s authorisation system for Genetically Modified Organisms (GM) remains problematically slow: Fewer products have been authorised in 2012 compared to previous years. The time it takes to authorise a product has not improved. Legally prescribed timelines to put products to the vote have not been met. The EU is falling further behind the main exporting countries of key agricultural commodities, which are accelerating authorisation processes. 2. The slow-down of the EU GM authorisation system, in combination with global trade and agriculture trends, is increasing the barriers and raising the cost, of the trade flow of key commodities to the EU. A first observable consequence is that the trade of key commodities is diverted to other markets, such as Asia, where demand is increasing. More, acute trade disruptions can be expected in the future if the EU does not normalise the authorisation process of safe GM crop products and eliminate the backlog in approvals. 3. Six policy responses are required to avert trade disruptions and cost increases: 1. Put products to the vote in a timely manner as required by law. 2. Improve efficiency of GM authorization system to close the time gap with exporting countries. 3. Adoption of workable approaches to stacked events and renewals of authorisations. 4. Extension of the technical solution for potential presence of not yet EU-authorised GMOs to food and seeds. 5. A comprehensive policy to deal with Low Level Presence (Adventitious Presence) of GM products yet unauthorized in the EU. 6. Strict adherence to science-based policy making. 4. Process efficiency recommendations were made in two external evaluation reports drafted for the European Commission i. Few have been implemented. They should again be considered by the European Commission and Member States. Failures of the EU Authorisation System for GMOs - Causes, Impacts and Solutions Produced by EuropaBio 1

2 FACTS AND ANALYSIS The charts below show the average time it takes for a GM food/feed/import (FFI) product to move through the EU authorisation process. Five observations can be made: months is the average time it takes to authorise a product for FFI (including risk assessment and processing safety assessed dossiers to the votes by Member States). 2. There has been no improvement of this amount of time in 2012 (chart 2) compared to averages of previous years (2004 to 2011, chart 1) months one third of the total time is spent after completion of the EFSA risk assessment on file processing and voting-related procedures, which are coordinated by the European Commission (charts 1 and 2). 4. It took the Commission on average almost 10 months in 2012 to draft authorisation decisions of safety assessed applications, and to bring these to the vote by Member States (blue in chart 2). The legal timeline is 3 months. 5. It takes longer to move stacked products through the system (chart 3). Slower processing and voting-related procedures are the cause of the slowdown. Notes regarding charts 1 to 3. These charts do not include products for which a cultivation request was submitted. There are 22 such products at various stages in the process. Seven of these have a positive opinion from EFSA and have been waiting to be processed by the European Commission for many years (see annex). Regarding chart 3, EFSA only starts its review of applications for stacked products after the EFSA opinions for the singles are adopted, hence the overall timelines for the stack review are largely effected by the timelines for the reviews of its singles. In charts 2 and 3, whereas the vote now takes place in the Appeal Committee, this previously took place in Council. Failures of the EU Authorisation System for GMOs - Causes, Impacts and Solutions Produced by EuropaBio 2

3 Box 1: How the EU authorisation should work. The EU has one of the world s strictest authorisation procedures for GM products. First, the European Food Safety Authority (EFSA) has a timeframe of six months to carry out an extensive scientific risk assessment. EFSA can put the risk assessment on hold if additional data are deemed necessary. If EFSA finds the product as safe as its non-gm counterpart, EFSA delivers a favourable opinion for its authorisation. In the next phase, a political decision must be taken which involves the Commission and the Member States. EU legislation requires the Commission to keep to specific timelines ii : it has a maximum of 3 months to ask the Member States to vote. If they vote and do not reach a qualified majority, the Commission has to organise another vote within 2 months iii. If again no qualified majority is reached, the Commission may authorise the product. The timelines set in EU legislation are almost always exceeded. THE EU AUTHORISATION SYSTEM HAS SLOWED DOWN Box 2: Data trends GM product submissions Data 74 products in the authorisation process (blue line). 55 of these are being examined by EFSA (red line). 19 products with EFSA positive opinions awaiting political action by the EC. All products in the EU authorisation system as of December Trends Every year, more product applications are submitted (green bars) than authorisations issued (yellow bars). Since 2010 the number of authorisations has decreased annually. The backlog continues to grow as new applications exceed authorisations. The evolution of the authorisation slow-down and backlog Global authorisation timelines are increasingly out of synchrony. The governments of the main exporting countries of agricultural commodities operate faster authorisation systems, and they have decided to accelerate further. While the EU still takes close to 3.7 years on average for an import approval, approvals in Brazil currently take just over 2 years, the U.S. is aiming at 1.5 years, and Argentina introduced measures to cut approval times by half (currently about 1.5 years). An approval in those countries means that the product is approved for both import and cultivation. One year difference can comprise one or two agricultural seasons in the exporting country. If the current rate of authorisation continues (6.6 authorisations issued vs new applications entering the system on average per year between ), the backlog of pending products will increase to 106 by Status Status Expectation Trend 1 Jan Jan Jan iv Backlog of products awaiting 65 products 74 products 83 products negative authorisation Time it takes to authorise a food/ 45 months 45 months 45 months no improvement feed/import (FFI) product in the EU Risk assessment stage in authorisation for a FFI product 29 months 30 months 31 months Negative Box 3: Why did GMO authorisation stall but not authorisations for other regulated products? Despite the fact that there are 19 GM dossiers waiting for Commission processing and Member State voting, four Standing Committee meetings were cancelled where these products could have been voted on between September 2012 and January Other regulated product groups under DG Sanco s responsibility continued to be processed as normal without cancellations of standing committee meetings. Failures of the EU Authorisation System for GMOs - Causes, Impacts and Solutions Produced by EuropaBio 3

4 Slow authorisations of stacked products a major concern Most GMOs entering the market today are stacked events, in which two or more GMO traits are combined by means of conventional crossing, thereby addressing regional farmer s needs. The number of stacks to be approved in the EU is growing. Different factors slow-down EU approvals of stacks. Stacked events do not require a separate authorisation in key exporting countries, as long as the constituent single events are authorised. Instead, for example in the USA, when a single event is approved, any combination of that event with other approved single events is automatically approved (or is approved thereafter with a fast-track procedure). Therefore, stacked events do not have to go through an additional full product authorisation as they do in the EU. In the EU, however, stacks not only need to be authorised, but their authorisation takes more time than that of single events, even if all the constituent singles of the stack have already been assessed. Number of products Total stacks in the EU authorisation system The EU has a policy of only starting the risk assessment of a stacked product once the risk assessment of the single events composing that stack is completed. Therefore vital time is lost. Lastly, the data requirements for stacked products are much higher in the EU than elsewhere, despite the fact that these are just seed products resulting from conventional breeding which has a long history of safety. The impact is that stacked products have the potential to reach the market in other geographic areas significantly before getting authorised in the EU. Box 4: Comparing risk assessment processes for pharmaceuticals and GMOs The European Medicine Agency (EMA) and the European Food Safety Authority (EFSA) are responsible for the opinions on the authorisation of pharmaceutical and GMO products respectively. Both pharmaceutical and GMO products undergo similar extensive evaluation processes, but there are important differences. Pharmaceutical products GMOs Timelines The authorization procedure may take up to maximum 210 days, and includes many steps; but at the end of this period, the committee adopts an opinion on whether the medicine should be marketed or not. There are rarely any delays. The 210 day period has distinct time-limited phases: for example, by day 80, the rapporteur coordinating the assessment must report, or by day 100, the rapporteur must have received comments from other reviewers, etc. Applicants can have pre-submission meetings with the EMA where they discuss the plans and developments. Meetings The applicable timeline for the total duration of the risk assessment phase is six months. This time limit is almost never adhered to in practice, as it can be extended by whenever EFSA requires supplementary information v. Many requests by EFSA for supplementary information result from retroactively imposing new requirements on pending applications. The different timelines set in the risk management phase are rarely respected. These are: 3 months to ask Member States to vote, and 2 months to hold a second vote in a higher committee. (Pre-) submission meetings are not an option with EFSA, despite repeated requests. Failures of the EU Authorisation System for GMOs - Causes, Impacts and Solutions Produced by EuropaBio 4

5 TRENDS THAT WILL LEAD TO TRADE DISRUPTION Biotech is the norm for several traded commodities. In 2011, the global GM adoption rates per crop were 82% for cotton, 75% for soybean, 32% for maize and 25% for rapeseed/ canola vi. Adoption rates are much higher in the main exporting countries. For example, in the US, Brazil and Argentina, soy adoption rates stand at 92%, 89% and 99%, respectively, and continue to increase vii. In 2014, more than half of global seeds sales are expected to be GM seeds viii. In 2011, 16.7 million farmers planted 160 million hectares of biotech crops in 29 countries. More farmers grow GM crops around the world than the total number of farmers in the EU. Continuing increases in: GM adoption, varieties and developers. Looking ahead to 2015, it is estimated that 20 million farmers will be growing GM crops in 40 countries on about 200 million ha, and that the number of GM events commercially cultivated worldwide will increase sharply. This includes new combinations of several GM events into one plant (stacks). Major new crops include potato, rice and banana. New traits include: stress tolerance (cold, drought, saline), healthier oils and improved grain quality. New developers include government laboratories in China, India, Brazil, Australia, and the USA. Farmers in the EU do not have the freedom of choice to use this technology due to the failing approval system applications submitted as early as 1996 are still trapped in the political deciosn process, despite repeated positive assessments by EFSA. Increasing EU dependence on imports of agricultural commodities. The EU is the biggest net importer of agricultural commodities ix. The biggest million ha M M T Soybean Other crops exporters are North and South American countries, where modern biotech crops are widely grown and have contributed to higher productivity. European import dependency is particularly high for soya where EU domestic production covers only 7% of demand. Soy proteins are key for EU animal production. EU livestock feed contains ingredients made from GM crops. There is rapid growth of traded commodities, most notably soy and maize products. The EU imports upwards of 30 million tons annually - equivalent to 60 kg per EU citizen per year (500 million) x. Asian nations demand for soy and maize products is increasing even faster, which increases competition for supply. More GM-related trade incidents. The likely presence of GMOs that are not yet authorised in the imports to the EU is increasing continuously. Exporting countries no longer follow a strict mirror policy with regard to approvals whereby they wait for EU approval, and exporters cannot cope with the logistical capacity of segregating GM material. Trade-related incidents are therefore more and more likely and EU authorities will be responsible for managing these. These incidents will decrease public trust in the capacity of authorities. Global GM hectarage Millions of tonnes of grain traded globally Projected 465 MMT 50 There is the increased cost of raw materials to the EU. 0 The overall cost to the economy of such disruptions could total 9.6 billion, according to a report published by the EU Commission xi. This negatively impacts EU farmers, livestock breeders, commodity importers and their users as well as food companies. If there is doubt, grain traders avert the risk that their shipments are denied from unloading in the EU and reroute to locations outside the EU. As the EU s relative importance in global commodity trade (maize and soy) decreases, it loses influence on the approval decisions of exporting countries. Failures of the EU Authorisation System for GMOs - Causes, Impacts and Solutions Produced by EuropaBio 5

6 POLITICAL AND PROCESS RECOMMENDATIONS FOR EFFICIENCY Political recommendations 1. Place more political emphasis on more efficient processing of GM import applications. Put the products to the vote by Member States in accordance with the timelines foreseen in EU legislation. Establish and implement a plan to put products to the vote and clear the backlog in Technical process recommendations can be found below. 2. Consider how greater efficiencies can be achieved in the processing of stacked products. The delay by the EU to authorize this type of products needs to be addressed, because they are dealt with in a more time-efficient manner in other jurisdictions. 1. Extend the technical solution for the potential presence of GM events, in traded commodities, not yet approved in the EU, to food and seed. The current feed-only approach is not coherent with the realities of the commodity and food manufacturing markets. The European Commission should fix the current situation whereby conventional fields have to be destroyed because of a very rigid application/ interpretation of the legislation. 2. Develop a comprehensive forward-looking strategy to deal with the increasing likelihood of Low-Level Presence (Adventitious Presence) of EU unauthorized GM products in feed, food and seed, and engage in on-going discussions on this subject with the major trading partners. Include practical consideration of unauthorized, discontinued, off-license products and products not submitted for approval in the EU. 3. Ensure that risk assessment is and remains science-based and proportionate to the risk being assessed- including on issues such as toxicity studies and anti-biotic resistance markers. Process recommendations Two independent external evaluation reports financed by the European Commission made a series of recommendations to increase efficiencies in the approval process. EuropaBio has also published a report xii. Each report identified shortcomings in the implementation of EU legislation and stated that efficiency gains are possible without compromising safety or changing legislation. The main recommendations were in the following areas: Process inefficiencies in the European Commission (predictability and timing for risk assessed dossiers) Efficiency improvements for EFSA, particularly regarding the completeness check, stacks, scope, sequential review, stand-alone applications and renewals Transparency and transition period to deal constantly changing requirements in EFSA guidance: tackling reinterpretation and retroactivity Tackling the escalation of data requirements Avoiding late and questionable mandates to EFSA Few of these recommendations are being implemented. For concrete recommendations on each of the above mentioned issues, please refer to EuropaBio s report Approvals of GMOs in the European Union xiii (2011). Failures of the EU Authorisation System for GMOs - Causes, Impacts and Solutions Produced by EuropaBio 6

7 ANNEX: TIMELINES FOR GM PRODUCTS WITH A POSITIVE EFSA SAFETY OPINION AND AWAITING COMMISSION ACTION Status as of 1 January 2013 Timelines not compliant with EU law Timelines compliant for the moment Product (scope) xiv Trait, company Application Received by EFSA xv Publication of EFSA Opinion Applications for food/ feed/ imports Months (m) and days (d) waiting for the European Commission (EC) to schedule first vote xvi : maximum: 3 months Rapeseed MS8xRF3 (ff) (renewal) male sterility, herbicide tol., Bayer 06/ /09/ m 11 d and counting Rapeseed GT73 (ffip - renewal) herbicide tol., Monsanto 06/ /12/ m 18 d and counting Maize MON863 (ffip - renewal) insect res., Monsanto 06/ /03/ m 03 d and counting insect res., herbicide tol., Maize MON89034x1507x Monsanto, Dow MON88017x59122 (ffip) AgroSciences 10/ /09/ m 06 d and counting insect res., herbicide tol., Maize MON89034x1507xNK603 (ffip) Monsanto, Dow 02/ /09/ m 06 d and counting AgroSciences Cotton MON531 (ffip - renewal) insect res., Monsanto 06/ /09/ m 17 d and counting Cotton MON1445 (ffip - renewal) herbicide tol., Monsanto 06/ /12/ m 17 d and counting Cotton MON531xMON1445 (ff - insect res., herbicide tol., renewal) Monsanto 06/ /03/ m 05 d and counting Rapeseed MS8, RF3 & MS8xRF3 (ffip - male sterility, herbicide extension of scope) tol., Bayer 06/ /09/ m 07 d and counting Soybean MON87705 (ff) altered for healthier oil, herbicide tol., Monsanto 02/ /10/ m 02 d and counting Maize MON87460 (ffip) drought tolerant, Monsanto 05/ /11/ m 17 d and counting Maize MON810 (extension of scope - insect res., Monsanto pollen) 03/ /12/ d and counting Applications including cultivation in their scope Maize 1507 (c) insect res., Pioneer, Dow voted after 47 m 22 d 11/ /03/2005 AgroSciences (25/02/09) Maize Bt11(ipc) insect res., Syngenta voted after 45 m 06 d 05/ /05/2005 (25/02/09) Maize NK603 (ffipc) herbicide tol., Monsanto 08/ /06/ m 22 d and counting Maize MON810 (ffipc - renewal) insect res., Monsanto 06/ /07/ m 03 d and counting Maize MON88017 (c) insect res., herbicide tol., Monsanto 04/ /11/ m 23 d and counting Maize GA21 (ffipc) herbicide tol., Syngenta 07/ /12/ m 17 d and counting Soybean MON (c) herbicide tol., Monsanto 11/ /06/ m 12 d and counting Months (m) and days (d) waiting for the EC to schedule second vote xvii maximum: 2 months 46 m 08 d and counting 46 m 08 d and counting i i ii Timelines according to Regulation (EC) No 1829/2003, Art 7 and Council Decision 1999/468/EC Art 5.4. iii Two months maximum under the new procedure involving the Appeal Committee (for some products under the old procedure involving Council even without delay ). iv Estimates based on business as usual scenario v Regulation 1829/2003, Article 6 vi ISAAA 2011 vii ISAAA 2011, for Brazil: Celeres 2012 viii Phillips Mc Dougall. The Global Seed Market: ix EU Commission, MAP, May x EU Commission, MAP, May xi Study on the Implications of Asynchronous GMO Approvals, on behalf of DG AGRI, Dec 2010: xii xiii EuropaBio 2011: Approvals of GMOs in the European Union : xiv This list does not include products which have been put on hold following an agreement between the applicant and the European Commission. xv Where the application date is before EFSA creation (2002), it refers to the date of application to Member State authorities. xvi Standing Committee or Regulatory Committee xvii Appeal Committee or Council Failures of the EU Authorisation System for GMOs - Causes, Impacts and Solutions Produced by EuropaBio 7