4. Conclusions

The first section of this chapter describes, within the limitations of the data, the fundamental aspects of the market for essential oils. Production is estimated to reach more than 150,000 tonnes or about \$6B USD in 2017 across the world. The main producers, by continent are China and India (Asia), Morocco and Tunisia (Africa), the USA, Canada, Mexico (Americas), and France and Germany (Europe). As a consequence of growth in consumer interest in natural and healthy living, of a rise in income in developing nations of the world, and of an increase in knowledge and use of essential oils (aromatherapy, spa therapy, and more), demand is expected to expand by 2020. Production often occurs on rural area farms (about 1.6 million farms, 0.6% of the world in total). World trade data values exports in excess of \$4B USD and imports above \$4.5B USD in 2016. Europe accounts for about 40% of world exports and it is expected to maintain this market share in the coming years due to the demand for essential oils in various sectors. At the country level, the US, Germany, the UK, and France are the main exporters. The latter three countries are also the main world importers. Demand for essential oils worldwide is driven first by companies producing flavourings and fragrances. Growing sales of flavourings and fragrances indicate future demand increases for raw materials (essential oils). The three main companies in the flavouring and fragrance sector are Givaudan, Firmenich, and IFF; combined, they represent 46% of total sales. Consumption is driven by the same factors described above that drive production. The following countries consume the most essential oils in the world: the US (40%), Western Europe (30%), and Japan (7%). The second section of the chapter examines the principal EU regulations governing essential oils. General regulations, known as REACH and CLP, refer to chemical products, which also affect essential oils. EU legislation for specific product uses (flavourings for food, cosmetics, additives for use in animal feed) also relates to essential oils. REACH and CLP concern the registration, evaluation, authorisation, and restriction of chemicals (essential oils included). They have many goals: to protect human and environmental health from the use of chemical products; to instil manufacturers and importers with the responsibility of understanding and managing the risks associated with the use of these substances; to allow free circulation of substances in the EU market through similar requirements in EU countries; to improve competitiveness and foster innovation in the EU chemical industry; to promote the use of alternative methods to assess the substance hazards and limit animal testing. All substances subject to regulation (waste excluded) must be registered and authorised, as described by these regulations. The European Chemical Agency, established by REACH, oversees application and authorisation for registry admission and ultimate entry into the marketplace. CLP regulates substance and mixture classification, labelling, and packaging. It determines if the properties of a substance or mixture are dangerous. It also ensures high levels of human and environmental health protection, a standard classification schema, labelling and packaging criteria for EU member states, and a catalogue of substances consistent with chemical classification used by the United Nations. Pre-market entry, dangerous substances, and mixtures must be 'selfclassified' by manufacturers, importers, and other related parties (downstream users) into a class and category of danger correlated with the related physical, human, and/or environmental health hazard(s). This regulation also details precise information and pictograms for substance/mixture label placement. Specific regulations for flavourings/flavouring ingredients are limited for those not of risk to consumer health on the basis of available scientific data and as long as their use does not mislead the consumer. Risks are assessed under a commission of the Food Safety Authority (EFSA) and enter into an EU list that allows their market entry as such or for use in food. These specific regulations also lay out label standards for intermediate and end-user sales. Cosmetics-related legislation aims to guarantee high quality and the health and safety of the consumer. It establishes the concept of a Responsible Person to submit all security documentation, safety reports, and safety assessments. Moreover, the Responsible Person must guarantee product traceability and market surveillance. The regulation also specifies label and advertising claims, rules on animal testing, manufacturing standards (GMP), indications relating to carcinogenic, mutagenic and toxic for reproduction (CMR) substances, and nano-materials. Additives for animal nutrition are the most important contents of the related regulation that applies 'only if the additive is authorised according to Regulation (EC) No 1831/2003 and the specific Authorisation Regulation, respecting the conditions set by this rule, can it be placed on the market, used and transformed'. The EFSA is the authority who manages the authorisation under the second principal regulation of interest for the examined products, Regulation (EC) No 429/2008 on "preparation and presentation of applications, evaluation, and authorization of additives".

## Acknowledgements

registered or recognised per Regulation (EC) 183/2005 guidelines. Finally, it should be noted that the authorisation for a new additive (Article 4) or for a new use requires submission of an application to the European Commission—Directorate General for Health and Consumer Protection (DG SANTE), that demonstrates compliance with paragraph 2 of Article 5 and at least one of the characteristics named in paragraph 3 of Article 5. Regulation (EC) No 429/2008 contains preparation and presentation rules for additive application, evaluation, and authorisation. Completed applications are forwarded to the Commission, which sends it to EFSA and to the VII-DGSAF Office of the Ministry of Health for evaluation by the member state Ministry of Health and Community Laboratory. At the end of the evaluation, EFSA issues an opinion (Article 8), which is sent to the EU Commission for preparation of an ad hoc regulation. Each authorised additive is entered in a community register with authorisation date, expiration

The first section of this chapter describes, within the limitations of the data, the fundamental aspects of the market for essential oils. Production is estimated to reach more than 150,000 tonnes or about \$6B USD in 2017 across the world. The main producers, by continent are China and India (Asia), Morocco and Tunisia (Africa), the USA, Canada, Mexico (Americas), and France and Germany (Europe). As a consequence of growth in consumer interest in natural and healthy living, of a rise in income in developing nations of the world, and of an increase in knowledge and use of essential oils (aromatherapy, spa therapy, and more), demand is expected to expand by 2020. Production often occurs on rural area farms (about 1.6 million farms, 0.6% of the world in total). World trade data values exports in excess of \$4B USD and imports above \$4.5B USD in 2016. Europe accounts for about 40% of world exports and it is expected to maintain this market share in the coming years due to the demand for essential oils in various sectors. At the country level, the US, Germany, the UK, and France are the main exporters. The latter three countries are also the main world importers. Demand for essential oils worldwide is driven first by companies producing flavourings and fragrances. Growing sales of flavourings and fragrances indicate future demand increases for raw materials (essential oils). The three main companies in the flavouring and fragrance sector are Givaudan, Firmenich, and IFF; combined, they represent 46% of total sales. Consumption is driven by the same factors described above that drive production. The following countries consume the most essential oils in the world: the US (40%), Western Europe (30%), and Japan (7%). The second section of the chapter examines the principal EU regulations governing essential oils. General regulations, known as REACH and CLP, refer to chemical products, which also affect essential oils. EU legislation for specific product uses (flavourings for food, cosmetics, additives for use in animal feed) also relates to essential oils. REACH and CLP concern the registration, evaluation, authorisation, and restriction of chemicals (essential oils included). They have many goals: to protect human and environmental health from the use of chemical products; to instil manufacturers and importers with the responsibility of understanding and managing the risks associated with the use of these substances; to allow free circulation of

date, and the relative Authorisation Regulation.

4. Conclusions

122 Potential of Essential Oils

The authors thank Dr. Tibor Verduna for his contributions (data research).

## Conflicts of interest

The authors have no conflicts of interest to declare.
