The draft regulation will create a common European register of commissioned studies. This is to guarantee that companies applying for a product authorisation submit all relevant information and do not hold back studies with unfavourable results.
Studies should be made publicly available and easily accessible in an electronic format via EFSA's website, with the possibility to search, download and print them. Citizens will also have “automatic and immediate access” to all safety related information submitted by industry in the risk assessment process.
The Commission proposal revises eight pieces of sectoral legislation, bringing them in line with the general food rules and strengthening transparency in the area of GMOs, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.
It will also increase EFSA’s budget by €62,5 million euros a year.
Data kept confidential 'if duly justified'
Intellectual property rights and data exclusivity will be guaranteed in line with existing EU law, and EFSA will protect confidential information “as long as this is duly justified”.
However, confidential information could be disclosed in two cases, it said. When urgent action is essential to protect public health, animal health or the environment and when the information is part of the conclusions of the EFSA opinion and relates to foreseeable health effects.
Ute Woelke, vice president of strategic regulatory affairs flavours and head of global raw materials at Symrise said it was difficult to find the right balance between intellectual property and transparency.
"We’ve seen these discussions over many years now. It’s understandable that there’s a wish to be more transparent but we also have to be clear that for companies that spend huge amount of their yearly budget on innovation, protection of that is important," she told FoodNavigator.
“What is key for us is consumer safety, that is absolutely mandatory, and we are committed to submitting whatever is needed so that EFSA or any other evaluating body can conclude our materials and products are safe."
The proposal, which covers the entire agri-food chain, will also apply to ingredients and products that have already been authorised by EFSA.
It also allows the Commission to ask EFSA to commission studies to verify submitted evidence if needed, and controls and audits to ensure that laboratories are compliant with the relevant standards.
Greater citizen access
The proposal comes as part of the Commission's Fitness Check of the General Food Law, which dates back from 2002, but also on the back of a European Citizens' Initiative in October last year, entitled 'Ban glyphosate and protect people and the environment from toxic pesticide'.
The initiative, which was submitted to the Commission, collected over one million (1,070,865) signatures, and included a demands to increase the transparency of scientific studies submitted to EFSA for opinions.
The Commission said the proposals will give citizens greater access to food safety information submitted to EFSA by industry and involve member states' scientists more closely in approval procedures.
Commissioner for health and food safety Vytenis Andriukaitis said yesterday: "The EU's science-based risk assessment for food safety is one of the most stringent in the world. We are now making it even stronger through clearer transparency rules and more effective risk communication throughout the process. With this reform citizens will have immediate access to scientific studies supporting applications for authorisation."
Before becoming law, it must go to members of the European Parliament and member states for approval. The Commission said it hoped to see it adopted by mid-2019.
An EFSA spokesperson said the Authority strongly welcomed the proposals and supported any effort to increase transparency and public confidence in EU food risk assessment.
‘Lifting the veil’
European consumer rights association BEUC welcomed the Commission’s decision to “lift the veil on the studies which help determine whether a GMO or a flavouring is safe”.
Senior food policy officer at BEUC Camille Perrin welcomed the register of commissioned studies, saying it would prevent industry from hiding away unfavourable results or even stopping the studies at the lab stage.
However, she added reservations about allowing pre-submission meetings between EFSA staff and individual industry applicants. “We will be very vigilant on how this is to work out concretely, because of the risk it might affect EFSA’s independence.”
“More fundamentally, if we are to restore consumer trust in how their food is regulated, we need more publicly-funded research driven by societal needs, not commercial ones. The EU must do away with the current trend of conditioning research funds to public-private partnerships,” Perrin added.
Beware the caveat
Corporate Europe Observatory’s food policy campaigner Martin Pigeon said that certain aspects of the proposal – the public register, EFSA’s budget increase and automatically publishing study data – were “a welcome first step in the right direction”.
However, he added: “The Commission’s proposal features a big caveat that means anyone wanting to quote and use the data will need to ask permission to do so from the company that has provided EFSA with this data.”
“This creates a huge risk that industry will block any scientific scrutiny of EFSA’s assessment of their products. If scientists cannot quote this data in scientific publications there will be only a limited incentive for the scientific community to double-check EFSA’s work.
"The publication of much-needed independent cross checks of industry data must not depend on the goodwill of private entities whose primary objective is to make a profit, not to protect public health and the environment.”
Europe's biotech trade group, EuropaBio, said that elements of the proposal could help increase trust and understanding of the science behind EFSA’s risk assessment opinions and the decisions of EU policymakers based on this.
“To date, these decisions have often been hampered by misunderstanding or mistrust of the system to the detriment of innovation, due in part to a lack of adequate information and in part to misinformation.”
However, the trade group added: “Disclosure of technical information, on its own, is unlikely to improve the public understanding of science and the trust in the risk assessment process.”
Its secretary general John Brennan said: “Our sector supports the objective to increase connection with the public and trust in the risk assessment process. We would like to see more transparency in the rules of procedure for risk assessment, and from Member States when it comes to whether or not they vote with the scientific evidence assessing product safety.”