A new red-tape mission is about to worsen the lives of Eastern European consumers, producers, and suppliers.  Under the influence of the Green Deal, the European Union’s Chemical Agency (ECHA) will transition to a hazard-based approachpremised on preventing any potential threat. Regulators will no longer focus on concrete exposure levels to determine whether a product is safe for consumers, as they used to in the older risk-oriented assessments. Instead, policymakers will use lab-related hypothetical scenarios or advanced statistical tests to label a consumer good as dangerous or remove it entirely from store shelves if it could constitute a problem in any way, shape, or form.

However, trying to achieve zero dangers comes at a high cost. In the case of the ECHA’s revised rules, increasing regulatory pressure raises the costs of complying with said rules. This increase leaves many smaller companies unviable, making perfectly safe goods unavailable to consumers. The effect will be decisive for Eastern European countries already heavily invested in chemical markets, which therefore have the most to lose from any disruption.

The best example of this dynamic comes from an unlikely source – essential oils. Often assumed to be just relaxation tools, these steam or water-based plant extracts are widespread ingredients in most toiletries, cosmetics, and perfumes and are the economic bread and butter of many Eastern European countries. Bulgaria is the world’s top producer of rose oil, with up to two tonnes of rosesharvested yearly in the famous region of Rose Valley. Not to be outdone, the Tedre farm in southern Estonia has cultivated a waste-efficient carbon monoxide method of extracting oil from its 2.5 hectares of raspberries. Though not comparable to Bulgaria or Estonia in terms of output, Lithuania does produce important essential oils like mint, chamomile, juniper, and spruce.

However, hazard-based regulations would have essential oils on the chopping block. Policymakers plan to replace their current designation as complex natural substances with the nebulous idea of ‘more than one constituent substance.’ In practice, this redesignation means that essential oils will be treated the same way as synthetic mixtures – subject to the complete restrictions of hazard-based rules.

Most Eastern European firms will quickly find their businesses unviable because of the ECHA’s decision. Like the Tedre farmers, Bulgarian cultivators in the Rose Valley, and Lithuanian agriculturalists, these producers and retailers tend to besmaller domestic enterprises. Scaring consumers away with severe warnings on labels and prohibiting products are extra costs they can ill afford to take on (which is why 85% of all firms signed up to onerous legislation are large international conglomerates).

The economic consequences for the essential oils market in countries like Bulgaria, Estonia, Lithuania, and others in the region will be severe. Looking at export numbers alone, Bulgaria could lose 445 million euros from its sale of essential oils and associated toiletries. Lithuania and Estonia’s numbers are more modest but still significant, at 379.9 million euroand 19.1 million euro, respectively.

Eastern European member states should encourage the ECHA to abandon its cause before it is too late. Tentative steps occurred on the 30^th of June when Bulgaria and seven other states in the Permanent Representatives Committee urged the European Commission to prepare a report four years into the future on essential oils. The analysis will outline different norms regulating the ‘more than one constituent substance’ category. Estonia, Lithuania, and all other Eastern European countries should join Bulgaria in this endeavor.

Yet they should aim to do more. They must encourage the revival of risk-based thinking in the EU’s attitude towards chemicals. Risk-bearing is the only form of decision-making grounded in concrete toxicological data, aware of the fundamental economic trade-offs, and sensitive to the consumer experience. The time to end destructive campaigns (no matter how well-intentioned they may be) is here and now.  

Originally published here

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

New EU rules are coming after scented candles, perfumes, and wellness routines. The clean beauty cosmetics market has grown substantially as more European customers move from synthetic cosmetics to natural replacements. Put into numbers, the sector reached 2.29 billion euros in 2022 and is projected to surpass 3 billion in 2026. This growth is thanks to water or steam extracts called essential oils. Chances are your favorite sustainable make-up includes one of nine-hundred ninety-two such emulsions – some of which are household names like lavender, cinnamon, rose, and sage. If that were not enough, your preferred bio-degradable perfume most likely comes from one of the fragrances essential oils provide. Nevertheless, consumers should worry about the future of the industry. The European Chemicals Agency (ECHA) wants to move from a risk to a hazard-based assessment of essential oils, leaving the entire business in limbo.

For non-experts, ‘risk’ and ‘hazard’ may sound the same. They are, however, very different ways of thinking about regulation. Hazard assesses the characteristics of a substance alone to arrive at a recommendation; risk, too, looks at the nature of a compound before also considering probabilities and exposure levels. Less abstractly, it’s the difference between judging cars as dangerous per se versus looking at the chances of an accident to decide whether the situation threatens one’s safety.

The consequences of each method are at odds, too. Where hazard will shy away from any material as long as there is even hypothetical proof that it is dangerous, risk assessment accepts that an item may pose a problem only after a certain concentration threshold has been exceeded. Using the same analogy again, it is akin to never hopping into a car out of fear of what could happen on the one hand and deciding to drive after establishing the safest route to go on the other.

The ECHA’s change of heart sees essential oils labeled as dangerous. So long as a single molecule (examined under the right laboratory conditions) becomes an issue, consumers will see a skull and crossbones on the beauty product’s packaging. Buyers then tend (research suggests) to avoid the items on sale.

Producers are consequently in a bind. They could look for alternatives to essential oils, yet most substitutes are already banned under EU regulation 2021/1902. So the option in many cases will be to pull out of the market altogether. As the dominoes fall, shampoos, shower gels, conditioners, foundation make-up, colognes, and deodorants are no longer available. Hazard-based thinking subsequently causes billions of euros in current and future revenue losses and leaves consumers with far fewer options.

The trouble does not end there, though. Several European countries are top producers of essential oils and will take the full brunt of the clean beauty market’s fall. Bulgaria is the world’s champion in rose oil extraction, responsible for distilling almost 2 tonnes of the material annually. Its 92 million euros worth of exports to France and Germany are now in danger. The loss would be another terrible blow to the EU’s poorest nation. France, the world’s third-largest producer of essential oils, sees 458 million euros wiped out thanks to the ECHA’s scheme. Italy is a crucial node in the global supply chain of one emulsion in particular – 95% of all bergamot oil is produced in the southern part of the country by a group of Calabrian families passing down techniques from generation to generation. Interrupting the trade will cost Italy upwards of 174 million euros and disrupt a way of life, all while throwing global trade into chaos.

Hazard cannot, therefore, wish trade-offs away, only worsen them. Giving up on a car will see you stranded when you need one the most; giving up on essential oils throws away valuable products and scuppers an entire business. Policymakers should encourage the ECHA to adopt a risk-based view, judging substances by safe use levels rather than all-or-nothing thinking. Now that is a wellness program all consumers can get behind.

Originally published here

Whether you’re applying perfume before a night out or mosquito repellent this summer, you might use essential oils in the process. The concentrated extractions from plants are used widely in the home and not only for wellness bloggers – they freshen up your laundry, treat your acne, and fend off fruit flies. Yet under EU new rules pushed, essential oil use could become severely disrupted. The Swedish presidency of the European Union has the chance to keep insect bites away from our summers.

The EU’s Chemical Agency ECHA has announced plans to shift its assessments of chemical compounds (which includes even simple plant extracts) from a risk-based assessment to a hazard-based assessment. The difference is not merely semantic. In risk communications, “risk” and “hazard” mean different things in the English language.

Let’s use the example of just being outside. The sun represents a hazard, because outside of giving you a sunburn through its UV light, it can cause more severe conditions such as skin cancer. People manage this hazard by limiting their exposure, such as standing in the shade, bringing in a parasol or applying sun cream. The equation thus becomes risk = hazard x exposure. The question of any risk assessment is therefore: how likely is it that a certain product will negatively affect its users?

If you applied a hazard-based approach to life, you would fear cars on roads you are not crossing, duck under planes that are flying at a normal altitude, or, quite frankly, not go outside at all. Unfortunately, ECHA intends on applying this overtly overcautious approach to essential oils, by labeling them as dangerous. The agency is incentivised to assess essential oil under the Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008), meaning it would require them to carry warning labels pointing to its danger or be restricted from sale.

As with anything, dosage makes the difference. While a glass of water is perfectly safe, consuming more than five liters in under an hour could actually kill you through water intoxication. The same applies to essential oil: while mosquito-repellent is perfectly safe for humans to use and (fortunately) very unpleasant to mosquitos, it can be toxic if you drink it. While this fact seems obvious to consumers, who are also advised to keep essential oils or chemicals such as cleaning products away from children, it appears to escape regulators who believe it is a hazardous substance.

If consumers do not have access to essential oil products or are disincentivized from their use, they are likely to shift to artificial and possibly more harmful alternatives, such as bug repellents containing diethyltoluamide, known as DEET, which can affect the human nervous system and negatively impact plants and animals.

Warning labels can have a lasting effect on how consumers view the products they buy. If essential oils are subdued by unwarranted danger labels, it could shift consumers to worse alternatives, and impact an industry that is also important. In 2022, the global market value of essential oil surpassed €24 billion. In 2021, France exported over €450 million worth of essential oil products. This means that regulation currently supported by the Swedish presidency would not only affect consumers in the EU and Sweden alike, it would also undermine this country’s own vibrant and developing industry.

Chemical policy is nerdy, and it’s certainly not as appealing as the essential oil used to make our perfumes. Yet it is important to remind regulators that a paternalistic and hazard-based approach to their classification is neither necessary nor practical. Policy-makers need to weigh the risks and benefits of each product and act accordingly. In this case, acting accordingly means NOT labeling everything that contains essential oils as dangerous, most importantly… because in moderate use they aren’t.

Originally published here