Polycyclic Aromatic Hydrocarbons in herbal medicinal products/traditional herbal medicinal products - Scientific guideline

The purpose of this reflection paper is to promote discussion about the presence of polycyclic aromatic hydrocarbons (PAHs) in herbal substances, herbal preparations and herbal medicines and to invite all interested parties including suppliers and manufacturers of herbal substances/herbal preparations, manufacturers of HMPs/THMPs, pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients' associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data or documented information (new, published or unpublished) and comments relevant to the evaluation of this problem.

Keywords: Herbal medicinal products; traditional herbal medicinal products; herbal substances; herbal preparations; polycyclic aromatic hydrocarbons; safety; HMPC

Current version

Reflection paper on polycyclic aromatic hydrocarbons in herbal medicinal products/traditional herbal medicinal products

Consultation dates: 29/06/2016 to 15/12/2016Draft: consultation closedReference Number: EMA/HMPC/300551/2015Summary:

The purpose of this reflection paper is to promote discussion about the presence of polycyclic aromatic hydrocarbons in herbal substances, herbal preparations and herbal medicines and to invite all interested parties including suppliers and manufacturers of herbal substances/herbal preparations, manufacturers of HMPs/THMPs, pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data or documented information (new, published or unpublished) and comments relevant to the evaluation of this problem.

Document history - First version (current)

Reflection paper on polycyclic aromatic hydrocarbons in herbal medicinal products/traditional herbal medicinal products

Consultation dates: 29/06/2016 to 15/12/2016Draft: consultation closedReference Number: EMA/HMPC/300551/2015Summary:

The purpose of this reflection paper is to promote discussion about the presence of polycyclic aromatic hydrocarbons in herbal substances, herbal preparations and herbal medicines and to invite all interested parties including suppliers and manufacturers of herbal substances/herbal preparations, manufacturers of HMPs/THMPs, pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States to submit any scientific data or documented information (new, published or unpublished) and comments relevant to the evaluation of this problem.

Overview of comments received on “Reflection paper on Polycyclic Aromatic Hydrocarbons in herbal medicinal products/traditional herbal medicinal products” (EMA/HMPC/300551/2015)

Reference Number: EMA/HMPC/679440/2017