Essential oil products generate hundreds of millions euros for several countries in Central and Eastern Europe. New rules threaten the industry.

New rules by the European Union’s Chemical Agency (ECHA) would significantly impact the commercialisation and use of essential oil products. 

This includes a wide variety of products consumers use, including everything from perfumes and other fragrances, to humidifier scents and insect repellents. The agency intends to adopt a new way of measuring harm caused by chemicals that doesn’t take into account the actual dosage that consumers will be exposed to.

It is unfortunate that the ECHA has chosen this exact moment to put overly restrictive chemical regulations in place. 

Following the European Green Deal’s footsteps and its vision of a toxic-free environment, the ECHA is replacing careful risk assessments based on actual exposure levels with a sweeping hazard-based approach grounded in hypothetical scenarios. The difference in practice between the two is radical. Where the first allows the use of a substance so long as it satisfies a safety threshold, the latter would prohibit compounds so long as something could go wrong.

The regulations will not spare even safe natural products from this effect, including steam and water-distilled (or manually pressed) extracts like essential oils. Under the current framework, policymakers classify them as complex natural substances. But all that would change with the hazard mentality, which would identify essential oils as mixtures of “more than one constituent substance” and restrict them as though they were volatile artificial materials, by legislation EU 2021/1902 on “toxic cosmetics”.

Impact in Central and Eastern Europe

The new ECHA guidelines will make it unfeasible for the sizeable Central and Eastern European essential oils industry to bring goods to the market. 

The businesses in Bulgaria’s famous Rose Valley harvest around two tonnes of rose oil yearly and earn 445 million euros for the country in exports of essential oils and toiletries. Similarly, the Tedre farm in Estonia produces 2.5 hectares of world-class raspberries and extracts raspberry oil based on a proprietary carbon monoxide method. Lithuania created 379.9 million euros worth of cosmetics exports from mint, chamomile, juniper, and spruce emulsions. 

Finally, Hungary benefits from 713.78 million euros of beauty industry exports. If only one part of a rose, raspberry, or mint product could be toxic or highly allergic, their goods will receive a harsh warning label at best. At worst, policymakers will make sure that they cannot commercialise these products at all. 

Firms in Bulgaria, Estonia, Lithuania, and other Central and Eastern European countries are smaller than most international conglomerates and cannot pay the extra costs of compliance; instead, they will withdraw their goods from exchange entirely.

The last thing Central and Eastern Europeans need right now is needless red tape complicating consumers’ daily lives.  The ECHA’s overly cautious approach would only add fuel to the fire. Inflation, the general rise in prices across the economy, has hit Central and Eastern European countries harder than most, leaving most people unable to afford as much as they did before and devaluing their savings. 

Annual inflation rates are projected to be higher than the 2023 EU average of 7.1 per cent (6.1 in the euro area) in countries such as Bulgaria (8.6 per cent), Lithuania (10.7 per cent), Estonia (11.2 per cent), and Hungary (a whopping 21.9 per cent). Yet the hazard-based process will ultimately exacerbate inflationary pressures.

Convincing the EU to change course

As the insights of economics show, the lower supply coupled with the same demand results in higher prices, driving inflation forward and causing more suffering to ordinary buyers. For all its good intentions, the hazard-based mentality will deteriorate Central and Eastern European consumers’ purchasing power and living standards.

The way to stop the worst scenario from materialising is to convince EU regulators to change course. 

Some member states, Bulgaria among them, have already acted via the Permanent Representatives Committee. 

On June 30 this year, the Committee requested the European Commission re-evaluate the status of essential oils as “more than one constituent substance” four years into the new legislation. All Central and Eastern European states should support the request. 

Moreover, they should champion the reinstatement of a risk-based mentality as the only science-driven option that keeps consumers safe without sacrificing their economic well-being. 

Central and Eastern Europeans would have one less thing to worry about.   

Originally published here

Lots of things are ‘possibly’ carcinogenic, depending how and in what quantities you consume them

The International Agency for Research on Cancer (IARC), a body associated with the World Health Organization, recently announced it will classify the artificial sweetener aspartame as “possibly carcinogenic.” The agency has yet to reveal the full data set on which this decision is based but whatever the upcoming release says, the announcement already has many consumers worried about their intake of sugar substitutes.

The truth is that aspartame is safe for consumption. The WHO’s new classification says more about flaws in the agency’s risk communication strategy than it does about aspartame.

IARC categorizes what it calls “agents” into four categories of carcinogen. Group 1 includes those where there is strong evidence of a link with cancer — radiation, for instance, or opium and tobacco. Group 3 agents have been analyzed and shown not to pose any cancer risk whatsoever. To the relief of many readers no doubt, one Group 3 agent is caffeine. Group 2A comprises those agents that are “probably carcinogenic,” indicating a higher risk than in Group 2B, which lists those agents that are “possibly carcinogenic” — which is where aspartame is going.

To determine whether an agent is carcinogenic or not, IARC does a hazard-based assessment, meaning it looks at an agent’s potential to cause harm, not the likelihood it actually will. But IARC is not a food safety agency and its findings say nothing about whether reasonable consumption would constitute a risk for consumers. In the case of aspartame, an individual weighing 60 kilograms would need to drink 12 to 36 cans a day of aspartame-sweetened soda to raise his or her potential cancer risk beyond baseline levels — which is why aspartame has been permitted for use in Canada and many other jurisdictions for over 40 years. While it is unclear how much of an increase you assume at the 12-36 drink range, it is likely less than one one-hundredth of a per cent, in absolute terms. Below this amount of consumption, consumers are not at risk.

Consumers need to understand that the responsibilities of the IARC are very different from those of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and that it uses quite different methods. JECFA has never found aspartame to be carcinogenic, while IARC, in the long list of products it has evaluated, almost always finds agents to be carcinogenic — because it does not take into account how much a reasonable consumer will take in.

For aspartame to be included in the 2B (i.e., “possible carcinogen”) category, only one of the following characteristics needs to be met: “limited evidence of carcinogenicity in humans, or sufficient evidence of carcinogenicity in experimental animals, or strong mechanistic evidence, showing that the agent exhibits key characteristics of human carcinogens.” “Limited evidence” means the agency does not need to establish a linear relationship between the agent and cancer in the same way it does in Group 1. This makes the “possibly” in “possibly carcinogenic” do a lot of heavy lifting.

The problem with IARC’s classifications is that ultimately they give consumers very limited information. When we remove exposure levels, i.e., dosage, from the equation, almost anything can become harmful. The sun is harmful on a hot summer day, yet most consumers limit their exposure by applying sunscreen or seeking shade. While there are instances in which the sun could be considered carcinogenic, it wouldn’t be good risk communication to label it as a cancer-causing agent, and therefore something to be avoided at all costs — not without alerting consumers to the fact that there is a healthy amount of sunshine they should feel comfortable getting. Just as there is an excessive amount of sunshine that would cause cancer, there is an excessive amount of aspartame that theoretically could too. However, most consumers don’t sunbathe to a cancer-inducing level or drink 10 litres of diet pop a day.

Aspartame and similar food additives have helped us move away from an additive we probably should consume with more care: sugar. Overconsumption of sugar can lead to significant health problems, including obesity and diabetes. Scaring people off artificial sweeteners by blurring the realities of risk perception risks pushing them back to sugar-sweetened drinks that are ultimately worse for them.

The classification of aspartame as a possible carcinogen also opens the floodgates for an entirely different scourge: tort lawyers. Especially in the United States, IARC’s hazard-based assessments have abetted class-action lawsuits that in jury-based trials have frivolously extracted millions of dollars from the manufacturers of safe products. This may enable some trial lawyers to afford high-rise apartments in New York but does little to advance public health.

Cancer is a major problem in our society, and more effort should be made to persuade consumers to modify behaviour that increases their risk of it. That said, advisory decisions such as the aspartame warning do the public health debate a disservice by distorting risk perceptions and feeding into conspiracies about the global food industry poisoning consumers.

Originally published here