- Rose oil is expected to be included in the European Pharmacopoeia within 2-3 years, which will allow its use in the composition of medicinal products.
- This will open up a new niche, a new market and a new opportunity for the sector, which has had a difficult few years.
- At the same time, the risk that it will be damaged by the controversial EU regulations has not yet been completely averted.
Herbal, lavender, pine and juniper oils have been listed for years in the European Pharmacopoeia - a standardized reference for the quality control of medicinal products in countries that have signed the Convention on the Development of Medicinal Products. This enables these oils to be included in various medicinal products and food supplements and opens up new niches and markets for them. Now rose oil is also on its way and this will open up many valuable opportunities for the sector.
Bulgaria is a leader in the export of the raw product that is used in perfumery, cosmetics and aromatherapy. However, these niches are no longer enough for companies, which are increasingly feeling the uncertainty and problems with supply chains in global markets. In order to maintain sustainability in the industry, to secure clients and plan stable deliveries, companies in the sector see a future in pharmaceuticals in particular.
Furthermore, the industry's focus over the past year and beyond has not been on its development, but on "saving" rose oil from artificially created smear campaigns and the European Commission's attempts to regulate potentially harmful elements in the composition of essential oils. So the initiative from the European Pharmacopoeia Commission (the decision-making body) to include rose oil in the European Pharmacopoeia marks a significant step forward. And although this process has nothing to do with Brussels' attempts to reform chemical legislation and enact new regulations for essential oils, the clearing of rose oil's name and image is more necessary than ever.
The path of rose oil into the European Pharmacopoeia
A pharmacopeia is a book containing guidelines for the identification of medicinal ingredients. The mission of the European Pharmacopoeia is to contribute to the protection of public health in Europe by emphasizing the quality of medicinal products and their ingredients. A procedure is currently underway for the inclusion of rose oil in the permitted ingredients for European pharmacology by the relevant institutions. The initiative comes from the European Pharmacopoeia Commission, which is working with industry representatives to achieve this. This committee makes all technical decisions on what will and will not be included in the pharmacopeia.
Nikolay Nenkov, owner of one of the leaders in the rose oil sector in Bulgaria- Galen-N, also took part in the process. During the second meeting of essential oil producers "Distilled in Bulgaria", which took place recently in Sofia, he told KInsights that he had been approached by the Medicines Agency this summer at the request of the European Pharmacopoeia Commission. "Bulgarian distilleries, including ours, were asked to send samples of our production to the Council of Europe, which is the "chapeau" of the European Pharmacopoeia. Samples of rose oil from different vintages and the region are used to carry out the relevant studies," says Nenkov. "This means that the international organization considers it appropriate to include rose oil in the circle of essential oils that can be used to treat and prevent various ailments and diseases," he adds.
The process takes about 2-3 years, but when it is completed, producers and processors will have certainty and predictability in the industry, says Nenkov. Vesela Chervarova from the company Bioland also believes that this will safeguard the future of rose oil and ensure permanently high purchase prices. Of course, this is also an opportunity for Bulgaria's regions to specialize in the production of rose oil with higher added value and to give a strong boost to the local and national economy, adds Nenkov.
Gray clouds over the rose fields
The sector has faced a number of challenges in recent years. After peaks in production and purchase prices in the period 2016 - 2018, there was a significant slump in the market. Purchase prices for a kilogram of rose petals fell to an absolute minimum - from 4.8 levs in 2016 to 1.8 levs in 2021, while the purchase price for a kilogram of crude rose oil also fell by half - from almost EUR 12,000 thousand at its peak to less than EUR 6,000 in 2020-2021. The reasons for this lay in the increasingly fierce competition on the international markets - for example from Turkey. These were exacerbated by suspicions of unfair practices by traders in the country. However, the most serious shock was caused by the Covid-19 crisis, which managed to block the sale of high-quality cosmetics and perfumes and reduce orders for rose oil.
In 2022, the market began to recover, but then came another threat - a reform in the chemical regulations from Brussels.
The Commission was doubtless well-intentioned - aiming at more concern for human health and the avoidance of potential risks which, according to some studies, may be hidden in certain molecules in the composition of essential oils. In practice, the new texts in the regulations do not consider rose and other oils as single and indivisible substances, but as a mixture of different ingredients that are now subject to regulation.
Labeling traditionally natural products as potentially hazardous led to serious objections from essential oil producers - not only in Bulgaria, but also in other essential oil producers like France. There was a risk that the labels of products containing essential oils would have to include a pictogram with hazardous content, which would deter consumers. The greater danger was that entire industries would refuse to use such oils and manufacturers feared that their products would be banned altogether.
In the end, the Council and the European Parliament conceded on part of the problematic paragraphs in one of the directives, which was finalized in the negotiations between the institutions last week. "We believe that we are close to finding a compromise that will satisfy the industry. Thank you to the joint efforts of the institutions, business associations and our representatives in the European Parliament, our arguments have been heard and accepted in the CLP (Classification, Labeling and Packaging of substances and mixtures)," said Margarita Alexandrova from the Ministry of Economy in Bulgaria, who is leading the negotiations on this issue in the Council.
Nevertheless, problematic texts remain in the second legislative initiative (the so-called REACH regulation- Registration, Evaluation, Authorisation and Restriction of Chemicals), the examination of which will take until the next EU mandate - after next year's European Parliament elections. This carries a certain risk, as it is not clear what the "green" mood among legislators will be in the new parliamentary term. The full impact of the reform, which is part of the European Green Pact, will therefore only become apparent after 2024.
According to Andrey Novakov MEP (GERB/EPP), who is one of the active Bulgarian representatives on this issue, it is more important than ever for Bulgaria to push the processes for the inclusion of rose oil in the European Pharmacopoeia forward so as to dispel any doubt about the benefits and advantages of rose oil for the environment and human health.