Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparative analysis of the EU regulatory requirements for essential oils as ingredients for the pharmaceutical, cosmetic products and feed additives ***

Dr. Olga Petina (Abschlußjahr: 2023)

Summary
Language: English
Due to their aromatic smell and specific pharmacological impact, the essential oils are used in the wide range of products: as feed additives, as active substances and excipients in medical products, and as fragrance and active substances in cosmetic products. This opens great economic opportunities for essential oils manufacturers and suppliers to sell their products to the customers from diverse industries. On the other site, essential oils become subject of diverse legislations with strong and complex requirements. In this study the European regulatory requirements for cosmetic ingredients, active substance and excipients for pharmaceutical use and feed additives have been reviewed in detail with the focus on essential oils.
According to the Directive 2001/83/EC the data on the quality of active substance is the integrated part of the marketing authorisation dossier for medical products. The essential oil manufacturers should provide data regarding the characteristics, manufacturing, testing and stability of their product according to the European legislation. Although there are various EMA (HMPC) Guidelines on herbal preparations the requirements, which were developed mostly for extracts, are not fully addressed to essential oils. The complex nature of essential oils, the production features (e.g. traditional steam distillation on the field, small batches sizes of crude oil, manufacturing often outside of Europe), many suppliers of plant material and crude oil with limited botanical/scientific education and experience in the manufacturing of active substance lead to the deviation from the Guidelines and intensive discussions between authorities and applicants.
The European Union strictly regulates the feed additives as well. The essential oils used as feed additive must be authorized according to the Regulation (EC) No 1831/2003 before the placing on the European market. In most cases essential oils are authorized under the Category “2” (Sensory Additives) and Functional Group “b” (flavouring compounds). This type belongs to non-holder-specific authorisations and once granted it could be used by every essential oil manufacturer if its product complies with the conditions laid down in corresponding Commission Implementing Regulation.
Compared to the active substances for pharmaceutical use and feed additives the cosmetic ingredients are not so detailed regulated in EU. Cosmetics Regulation (EC) No. 1223/2009 is aimed only indirectly to the suppliers or manufacturers of the substances used as a cosmetic ingredient. From this reason the cosmetic industry developed mechanisms for self-regulations, e.g. through standards created by industry associations (IFSA Standards), private certification (ISO 9001, EFfCI GMP etc.) or own requitements of single cosmetic company. Moreover, the market players obliged to carry out the comprehensive requirements of REACH and CLP for essential oils manufactured or imported in EU and EEA while the essential oils as ingredients for medicals and feed are out of scope of these regulations. This results in a significant amount of documentation that must be provided by essential oil suppliers for cosmetic sector, similar to that required for active substances in pharmaceuticals and feed additives. However, unlike pharmaceutical and feed industries, these documentations are not harmonized.
Although the fundamental principles like the high requirements for the quality of essential oils, quality control, manufacturing standards, supply chain traceability are similar for all industries discussed in this work the mechanisms and documentation reflecting these differ depending on the scope of essential oil application. As result, the essential oil suppliers, which are usually small and intermediate entrepreneurs, should be familiar with diverse European regulations and the final product should be consider as a combination from the essential oil itself and the appropriate documentation which play a critical role that the supplier is competitive on the market.
Pages: 71
Annexes: 1, Pages: 7