Regulatory situation

Anon. Regulatory Situation of Herbal Medicines A Worldwide Review. Geneva, Switzerland World Health Organization, 1998. 

The regulatory situation is liable to change and is also subject to the influence of various interest groups. The proponents of industrial biotechnology, represented for example by the BIO and EuropaBio industry associations, need to maintain or even increase the level of activity on this front, which requires commitment from their members. 

For general background information, on the regulatory situation up to 1999, refer to the regulatory update (331). The main source of information is the website of the European Stabiliser Producers Association (ESPA) (www.stabilisers.org). 

Globally, a wide range of conventional policies control the availability of herbal products to the general public. How this is accomplished depends on their derivation and whether they are categorized as medicinals, drugs, botanicals, or dietary supplements. The status of the regulatory situation as viewed worldwide in 1998 is available online (WHO, 1998). However, as... 

IV Regulatory situation (licensing status) in the country of manufacture... 

Regulatory situation in other countries (Marketing authorization, withdrawn from the market, application rejected, deferred or withdrawn.) ... 

Despite this fact, some governments are now enforcing regulations that are based on test methods that are not suitable for determining formaldehyde exposure levels and risks. Thus, some countries have regulated the formaldehyde content of particleboard, relying on the perforator method, European Standard Method EN 120) (4) which theoretically measures the total quantity of free formaldehyde in particleboard. The current regulatory situation for some countries is shown in Table II. 

Bulletin of the World Health Organization. Regulatory situation of herbal medicines. A worldwide review. Geneva, 1998 1-43. 

All these assays are extremely sensitive, but in most regulatory situations, positive results require further confirmation by instrumental methods. 

The ADI provides the bright line between exposures that are safe and those that are unsafe. Because it is a primary (i.e., a non-derived) food safety standard, it is easily interpretable across a range of regulatory situations. However, with the exception of residue determinations made using bioassays, because the ADI reflects total residues of concern, it cannot provide a standard for regulatory enforcement. Maximum residue limits (MRLs) and tolerances (in the USA) provide that enforcement standard. 

The following subsections provide information on the regulatory situation for each of the EDTs under consideration. As mentioned in the Preface, useful input on... 

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