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Full Version: Is A New Regulatory Limit for Thujone Needed?
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Provenance
The question of whether there should be regulatory changes for chop.gif intake limits is the topic of a new artycile by Lachenmeier in Regulatory Toxicology and Pharmacology, "Risk assessment of thujone in foods and medicines containing sage and wormwood – evidence for a need of regulatory changes?"

The short answer is no.

QUOTE
It was not until the 1960s that the first systematic toxicological studies in animals were conducted; these demonstrated that the effects were threshold-based and allowed for the estimation of acceptable daily intakes of thujone (Surber, 1962; Margaria, 1963). In 1979, the Codex Alimentarius Commission proposed the following maximum chop.gif limits in food and beverages: 0.5 mg/kg for ready-to-eat foods and beverages in general; 5 mg/kg in alcoholic beverages containing less than 25% vol; 10 mg/kg in alcoholic beverages above 25% vol; 25 mg/kg in food containing sage; 35 mg/kg in bitters and 250 mg/kg in sage stuffings (Codex Alimentarius, 1979). With the exception of the 250 mg/kg limit for sage stuffings, the Codex Alimentarius proposal was introduced into the European Union law in 1988 (European Council, 1988), which re-legalized the production of absinthe from wormwood as well as the food use of other chop.gif-containing plants. This European regulation has recently been amended to now regulating only beverages and the 35 mg/kg limitation applying to all Artemisia-derived alcoholic beverages (and not only bitters) (European Parliament and Council, 2008). However, the specific limits for sage preparations and the general limit for foods were removed from the regulation, so that Artemisia absinthium, Salvia officinalis and other thujone-containing flavouring plants can now be used in foods without restrictions.


QUOTE
While the restrictions for foods have been lowered, the opposite has occurred for medicines. In addition to food and beverage use, Artemisia absinthium L. and especially Salvia officinalis L. are common medicines and are sold as such, or as preparations or extracts (e.g., sage tea). The European Medicines Agency (EMA) has recently evaluated herbal medicinal products containing both plant species (EMA, 2009a; EMA, 2009b). Although the assessors judged the toxicological data on chop.gif and the quality of available studies to be insufficient to set a maximum daily intake, the EMA nevertheless proposed a daily intake of 3.0 mg/person as acceptable for a maximum duration of use of 2 weeks in the Artemisia absinthium monograph (EMA, 2009a). An increased acceptable daily intake (ADI) of 5.0 mg/person was later implemented in the Salvia officinalis monograph (EMA, 2009b). As these new EMA ADI values also question the current practices for food (e.g., the intake of 3 mg could be reached by drinking less than 100 ml of a spirit containing 35 mg/kg of chop.gif), our intention with this article is to re-evaluate the toxicological evidence concerning thujone. In addition, we will update the risk assessment using the "benchmark dose" (BMD) approach that is currently preferred by international agencies and in the scientific literature over the previously used "no observed (adverse) effect level" (NO(A)EL) (see, e.g., Filipsson et al., 2003; IPCS, 2009; Bi, 2010).


QUOTE
The human study also did not report any side effects during a six-week study period where 250 mg wormwood in capsules was administered three times a day (Krebs et al., 2009).


QUOTE
In conclusion, the evidence does not point to any need for changes in regulations but confirms the current limits as sufficiently protective for consumers.
Alan
QUOTE(Provenance @ Aug 26 2010, 08:32 AM) *

The short answer is no.

Or maybe, if I read it correctly, it depends where you are.

I believe you mean "no" based on the EU perspective of Lachenmeier.

Given that the EU limit is so much higher than the USA etc, doesn't this study indicate that the US limit could indeed be changed to reflect the EU?
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