Thursday, June 20, 2024

Fragrance Ingredients Are at Risk in the European Union

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L’Oréal chief executive officer Nicolas Hieronimus has always had an affinity for fragrance. But rather than take a victory lap while being inducted into the Hall of Fame at the Fragrance Foundation awards in New York on June 15, he used the time onstage to give an impassioned rallying cry.

“I would like to call on everybody in the room, on the actors of this industry, to join forces in the face of [regulations] threatening our art, which is about creating fragrances and emotions,” he said.

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“In Europe, and by extension in other places like California, there are regulations being worked on with very little scientific background and with hasty decisions that may limit considerably the access to many raw materials, particularly naturals,” continued Hieronimus.

“Can you imagine fragrances without citrus, without bergamot, without jasmine, without rose? It’s impossible,” the executive said. “So I call on everybody to mobilize with their trade associations, with the industry associations in every country. We have to defend this very beautiful creative art of perfume.”

Hieronimus’ concern echoes that of many as various proposals wind their way through the European Union’s governing bodies. How it all plays out could change fragrance-making as it is known today and will likely impact well beyond the union’s borders. This is because individual states in the U.S., such as California, and other geographic zones often follow the EU’s legislative stance on perfume ingredients.

Fragrance is a big — and growing — business. This year, it’s expected to generate $49.4 billion, then $50.8 billion in 2024 and $52.4 billion in 2025 worldwide, according to Statista data.

The European fragrance industry, which produces synthetic and natural fragrance ingredients for consumer products, such as perfumes and personal care, is a cornerstone of the continent’s economy, making an estimated 8 billion euros annually, according to the International Fragrance Association, or IFRA, which represents the fragrance industry.

It’s an industry at risk. Most recently, the Council of the European Union debated a proposal to always override safety data on natural ingredients — referred to as substances of more than one constituent, or MOCS — due to the classification of a single ingredient above the threshold of 0.1 to 3 percent.

A rose.A rose.

A rose.

“[That is] moving more and more away from a scientific approach, which really takes into account not only the potential hazards of a substance, but also what levels this substance is actually present in a consumer product,” said Joris Theewis, global regulatory strategy lead, scent, at IFF, adding people’s actual exposure levels should be considered, too.

The proposal came at a time when natural ingredients are growing in importance, as consumers are increasingly demanding more in their perfumes. Any ban on such substances would have a dramatic, knock-on effect across the whole scent industry. It could impact 80 percent of the current fragrance catalogue, including some of the most iconic perfumes, estimates show. And not all ingredients can be substituted.

The industry concerns seem to have been heeded. A week ago, late on June 30, the Council voted on the CLP regulation and decided to maintain the approach currently used for the classification of MOCS. And a review clause was introduced requiring that the EU report to the European Parliament and Council on articles linked to the MOCS classification four years after the revised CLP regulation is put into effect.

The fragrance industry lauded the decision.

“The natural fragrance ingredients used in perfumes, cosmetics, and personal and home care products are not deliberate ‘mixtures’ — they are substances that occur naturally. These can have hundreds of constituents depending on the geographical origin of the plant, climate conditions and so on,” said Aurélie Perrichet, regional director for Europe, IFRA, in a statement released right after the proposal was handed down. “The option the Council has opted for would continue to allow for these MOCS to be classified based on all relevant available scientific data — whether on their individual constituents or on the full substance.”

“From essential oils to plant extracts or absolutes and others, fragrance and cosmetic sectors use natural ingredients to respond to growing societal demand for more natural products, meet the expectations of our consumers and deliver products they value and love,” said John Chave, director general of Cosmetics Europe, which also represents the European fragrance industry. “Cosmetics and fragrance sectors are moving away from fossil-based materials, in line with the overarching objectives of the European Green Deal — and the Council’s decision today supports this collective aim.

“The current approach already achieves the highest standards of consumer safety and any changes to chemicals legislation have cascading effects on consumer products, such as cosmetics,” he continued.

L’Oréal welcomed the EU Council’s stance. “The introduction of a review clause after four years to specify the rules seems perfectly reasonable to us,” a L’Oréal spokesperson said. “This period will allow for informed scientific debate and the involvement of all the players concerned on this complex subject.”

It gives industry players time, for instance, to tackle each downstream regulation regarding naturals’ safeguard clauses, proposals for which will probably come at the end of this summer.

“In the meantime, we will continue to apply strict rules, as we have always done, to protect the health of our consumers and limit our environmental impact,” the L’Oréal spokesperson continued. “In addition, by offering a broad spectrum of fragrances, the industry generates value for European manufacturers and retailers, and contributes to Europe’s global competitiveness. Made up mainly of [small and medium-sized enterprises] and [intermediate-sized enterprises], perfumery is one of the leading employers in Europe and the sector. There are thousands of growers and producers in the supply and value chain who have perfected their craft over the centuries, and who provide a living for many families in small farming communities across the EU.”

The European Green Deal, under which most of the pending fragrance-related proposals fall, has as its umbrella aim to make Europe the first climate-neutral continent. Among its subgoals is to have the continent be carbon-neutral by 2050, its economic growth decoupled from resource use and no person or place left behind. “The goals of the EU Green Deal are fantastic,” said Sam Chebl, head of regulatory EMEA, fragrance and beauty at Givaudan. “We are all behind them.”

Still, there’s been a swell of perfume industry and trade association delegates lobbying hard to protect the fragrance trade, which can be highly impacted by parts of the proposal.

“European lawmakers have shown a great interest in the European fragrance industry, which has a leading position in the world, and the greatest concentration of activities from agriculture to research and innovation to glassmaking,” said the L’Oréal spokesperson. “We are hopeful that the European Parliament will also support a position that will advance the EU’s agenda and support the thousands of SMEs, growers and producers, which make up this unique European industry and preserve its savoir-faire and contribution to economic growth.”

It is expected the Parliament will meet this fall to discuss the Council’s proposal.

The fragrance industry is by no means out of the woods yet in safeguarding its ingredients. “The Council’s position is only one of three in the trialogue between Parliament and Commission, so we still need to await the end-result of this legislative process,” said Theewis.

Another question mark hangs over maintaining safeguard clauses on naturals, including lavender, ylang-ylang and rose.

A lavender field.A lavender field.

A lavender field.

“Typically, if there are naturally occurring ingredients present that have a hazard flag, we proceed with a safety approach, managing the risk, making sure that the levels we use are 500-times below any detected toxicity,” said Chebl. “There’s suddenly this whole ecosystem and value chain that is threatened.”

“Also, we still face a considerable challenge under the cosmetic product regulation, or CPR, for constituents of natural ingredients that are classified with a Category 1B for reproductive effects,” continued Theewis. An example of this is para-cymene, which is abundant in some natural oils such as thyme and cumin. If such ingredients are not explicitly exempted from the regulations, they could be banned for use in cosmetics just based on the presence of one substance.

The Registration, Evaluation, Authorization and Restriction of Chemicals, or REACH, governing regulation for the management of chemicals in Europe that came into effect in 2007 is also impacting fragrance development. Its first mandate is to ensure that every chemical circulating on the continent is monitored.

“It is the most [advanced and] conservative in the world already, and it’s about to get even more conservative under the umbrella of the EU Green Deal,” said Chebl.

“EU REACH will be updated with additional requirements expected for the lowest-volume substances, which contain most of the natural ingredients,” said Theewis. “We expect many additional safety studies to be required, including multiple endocrine-effect screening studies, and full safety assessments, which will create a massive administrative burden for our industry and could prompt more hazard classifications for effects occurring in very high dosages that are not relevant for consumers, but would trigger bans in consumer products.”

To many, such moves would overlook years of toxicological and safety data and put into jeopardy some materials used for hundreds of years very securely. “We’re at risk of missing out on good science, basically,” said Chebl.

Already some fragrance ingredients have been banned, such as butylphenyl methylpropional, or lilial, which gives the essence of lilies. On March 1, 2022, it was forbidden to be used in personal care products in the EU, after the Commission classified it as a “reprotoxic” — a chemical that negatively affects fertility and fetal development.

“When you say REACH and CLP are amended, it means all the downstream regulations which govern the products that make it to consumers would be affected, meaning the cosmetic regulation, the detergents regulation and so on,” said Chebl.

Another key element associated with fragrance chemicals within the Green Deal is the Chemicals Strategy for Sustainability, or CSS, which aims to reshape chemical-related legislation to ensure the chemical sector reaches its goals quickly.

“Because of this simplification and speeding process of the usual way of managing chemicals, we’re finding ourselves in difficult situations that are putting a lot of materials at risk,” said Chebl.

Apart from the Green Deal is the subject of fragrance-related allergens. The number of those, which need to be labeled whenever leaving factories, has swelled from 26 in 2003 to an expected 81 today.

Some industry experts believe the way allergens are being discussed raises concerns by consumers questioning: “They’re declaring more allergens?”

“It’s an extended declaration to guide [people] in case of an excessively rare reaction,” said Chebl. “You can imagine the cost that will be incurred by all of these relabeling activities. Even though the industry has five years to become compliant, there’s potentially going to be a lot of package destruction, which is a bit counterproductive, because we’re going against green goals.”

This swiftly shifting landscape challenges perfumers.

“It’s a really hard subject, because it’s all about chemicals, but chemicals are in nature,” said perfumer Lyn Harris, who sees bright spots, however.

“What is great is the fragrance houses find the means through the distillation process to be able to remove that constituent that’s harmful,” she said. “In a couple of years, you’ve got this beautiful material again, but you have to go through a bit of pain to get there. The perfumer has to adapt, and we all have. It tests your creativity. I actually look at it positively — I have to.”

In formulating a perfume she’s now always especially mindful of ingredients.

“It becomes part of you,” said Harris. “I am connected to one of the most amazing fragrance houses in the world, which is Robertet, and their code book does guide you. You do have choice. It opens you up — you just have to be really flexible and very determined. You have to embrace change.

“We are all reformulating,” she said

As fragrance executives prepare to focus on upcoming EU revisions of REACH and the cosmetics regulation, expected to be voted on at the end of 2024 or in 2025, they are looking to safeguard that new hazard classes are put forward in a more scientifically sound manner. “Just because something carries a hazard, it does not make it risky,” said Chebl.

Fragrance is the only specialty ingredients industry to have instituted safety requirements voluntarily, via IFRA, and some of those have been codified into law in the EU and elsewhere.

“So it would be a shame to suddenly say that all of this is not enough, and not valid, and turn the industry upside down over no real safety concern,” said Chebl, adding it’s also not very green.

Gaining critical mass, the fragrance industry is joining forces with the trade associations of other, larger industries, such as cosmetics, detergents and home care, in its battle. “Companies need to mobilize to showcase fragrances’ contribution to our culture and well-being, and to our economies and biodiversity,” said the L’Oréal spokesperson.

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