Toward an EU Ultra-Processed Food Directive
Is the European Commission Able to Understand Basic Risk Management Principles?
Health science activists and NGOs are pushing the European Commission to launch a directive or regulation against what they have deemed “ultra-processed food” (UPF). It sounds like something in line with what Brussels bureaucrats would like to busy themselves with, but what would such a directive entail?
It would need a clear taxonomy – what is and is not to be defined as an ultra-processed food?
What ingredients added to food would be considered as safe (ie, not ultra)?
Would it be a regulation or a directive?
Would the European Commission consider regulatory impact assessments?
What significant stakeholders would be allowed to lobby the process (including health advocates, medical associations, NGOs, industry groups, a wide range of actors down the food value chain, restaurant groups and food supplements manufacturers)?
As a veteran of the REACH regulation two decades ago, I wonder whether Brussels still has the regulatory sophistication or will-power to push through such a monster policy process again.
From a risk perspective, my focus on any EU ultra-processed food policy process is more basic: Would any directive be risk-based or hazard-based?
As risk equals hazard times exposure, a risk-based regulatory approach would focus on measures to reduce exposure to hazards.
The hazard-based approach demands that a substance or product is proven to be safe (at any exposure levels) in order to be allowed onto the market.
Given that any EU Ultra-Processed Food Directive would be led by DG Santé (the European Commission’s Health and Food Safety Directorate-General), with their lock-step relations with the World Health Organization, my suspicion is that they would take a hazard-based approach (more precautionary and not focused on setting exposure levels to UPFs). The WHO’s International Agency for Research on Cancer (IARC) is considering a monograph on UPFs. As IARC take a hazard-based approach (disregarding exposure levels), they will certainly determine this large, ill-defined class of food ingredients as carcinogenic, pushing the momentum further onto the European Commission’s regulatory schedule.
Ad Hoc Risk Management
At a recent risk communications conference in Brussels, I tossed a slow-ball question at Jiri Sochor, a senior official at the European Commission responsible for Food Improvement Agents, on whether DG Santé favors the risk-based or hazard-based policy approach. His answer surprised me.
Sochor said in situations where a substance or product is essential (and cannot be banned), the European Commission takes a risk-based approach, and where it is not essential, they preferred the hazard-based route. Sochor’s answer was definitely a foul ball since he basically admitted to a room of risk specialists that the European Commission does not have a clear risk management strategy.
I followed up my question to Jiri over the break asking directly whether any Ultra-Processed Food Directive would be risk-based or hazard based (according to his delineation of essential products that could not be banned). His answer was even more frightening, informing me simply that there won’t be such a regulation.
Perhaps that was wishful thinking on Jiri’s behalf, but policy pathways do not follow a straight line in Brussels. For example, the European Commission was forced into rushing through a precautionary policy against neonicotinoid pesticides under pressure from French Environment Minister, Ségolène Royal, in return for France’s support on another unrelated issue during an EU Council meeting and the hope of the Hollande goverment to attract more votes from French greens and the far left. The results of the European Union’s precautionary ban on neonicotinoids were catastrophic for farmers, for the environment and for bees. See my BeeGate exposé of this sad story of a bad regulation.
On so-called ultra-processed foods, activists, NGOs, foundations and medical associations are intensifying their lobbying pressure on sympathetic bureaucrats in DG Santé. It just takes one damning report (perhaps in the Lancet) plus a false flag crisis (IARC?), to motivate some external pressure group or struggling EU leader to force the European Commission down another deep regulatory rabbit hole.
But is Brussels ready for a long, drawn-out regulatory process on ultra-processed foods? That begs an even more important question.
Does Brussels Understand Risk Management?
If senior officials in the European Commission DG for Health and Food Safety (and Animal Welfare) can’t even articulate a clear risk policy strategy and bounce between the hazard-based and risk-based approaches according to potential consequences emanating from their policies, then the answer is: No! Brussels is not ready for an ultra-processed food directive, or any regulatory process for that matter.
I am reminded of the chaos resulting from the EU’s Sustainable Use of Pesticides Directive. Shortly after REACH, the European Commission and Parliament chose not to consider any regulatory impact assessments (ie, on what might be the impact if a large number of pesticides were taken off of the market). Industry seemed helpless to insist on this basic requirement. The Directive also took a hazard-based approach without any stakeholder objection. What did this mean?
The previous directive, 91/414 (Oh how I miss those days of coded language and secret handshakes) was risk-based, setting and enforcing maximum residue levels (MRLs) for pesticide residues. This was a rational risk management approach: determine at what level a substance can harm the most vulnerable consumer and then reduce the allowed exposure levels significantly. The process then encourages regulators and researchers to work together to continuously try to lower the exposure levels (as low as reasonably achievable - ALARA).
The Sustainable Use Directive replaced 91/414. It was hazard-based, choosing not to focus on levels of exposures to pesticides, but on the demand for companies to prove that a pesticide is safe. Recall that there is no such thing as safe in toxicology (or in reality) but rather safer levels. The Directive got even more absurd when a further condition was added. In reauthorizing existing chemicals, companies had to prove that they were not endocrine disruptors. Without clear definitions of tolerable exposure levels, every substance that could not be proven to not be an endocrine disruptor would require the precautionary principle to be invoked and the EU began arbitrarily taking large numbers of pesticides off of the market. Such an add-on was ridiculous - coffee is an endocrine disruptor - but this type of opportunism happens in weak regulatory structures.
It became very clear shortly after its implementation that the Sustainable Use of Pesticides Directive was unworkable. No hazard-based regulation is workable. And now the same activists, older, with better networks and more money, are readying Brussels for an Ultra-Processed Food Directive. Following the activist playbook, they will insist that the regulatory process be hazard-based, and ignorant EU civil servants will not understand what the problem could be with such an approach. The food industry marketing gurus will be spending their time trying to reassure consumers that their products are not ultra-processed (according to whatever mystical definition is conjured) and won’t even notice the regulatory playbook being stacked up against them. This is madness.
Enjoy your raw milk.
If an Ultra-Processed Food Directive is hazard-based, it will become very clear early on that many food stabilizers, additives and important, well-tested ingredients or processes will be taken off of the market in the EU (and given export levels, they will effectively be banned globally). If implemented to its full effect, every packaged food in Europe would be banned, only because the industry toxicologists could not assure regulators that their ingredients were 100% safe. And yes, coffee will be banned under the EU’s demand to invoke the precautionary principle whenever safety is not certain.
Maybe our Brussels bureaucrats should try to understand risk management.
A White Paper on Risk Management
Since first week of the COVID-19 precautionary lockdowns, when I first realized how absolutely ignorant regulators were about basic risk management principles, I have been calling for an EU White Paper on Risk Management. There needs to be guidance on the steps to take in any risk management process. The hazard-based approach, connected to a twisted definition of the precautionary principle that expects every substance to be safe (with certainty), is uncertainty management – a bastard-child of risk management.
I will release a one-pager tomorrow on what a White Paper on Risk Management should consider. For example:
policy processes should start with a risk assessment, identifying hazards and the means to reduce exposures
the use of scenario models, impact assessments and risk reduction strategies are vital tools that need guidance documents
there needs to be a clear strategy on risk communications
precaution is meant to be a last resort when risk management has failed to reach an acceptable level of protection, but in the European Union and more frequently now in the US, precaution is seen as the first, and only measure
a White Paper would also need to determine the proper definition of the precautionary principle.
When an experienced EU official believes he can move between hazard-based and risk-based policy approaches, in an ad hoc manner, depending on how serious the consequences might be, then it is time for a technical policy document to guide officials and keep EU policy credible and responsible. We cannot have an Ultra-Processed Food Directive, or any other directive in the EU until European officials understand what risk management actually entails.
But clarity on risk management would go against the strategies of activists, NGOs and interest groups and make the policy process more difficult for regulators (precaution is an easy tool). Industry leaders have to get off of their butts now and stop pretending that everything will be fine if they just go on talking about better regulation. Just ask people in the pesticide industry.