Executive Summary:
This Commission Recommendation (EU) 2015/976 addresses the need for monitoring the presence of tropane alkaloids in food due to their potential occurrence as impurities. It urges Member States, with the collaboration of food business operators, to perform monitoring activities and investigations. Analytical results should be provided to EFSA by October 2016.
Key Points / Main Content:
Monitoring of Tropane Alkaloids:
* Member States should monitor tropane alkaloids in food, focusing on: buckwheat, sorghum, millet, maize, flours of the above, cereal-based foods for infants and young children, breakfast cereals, grain milling products, grains for human consumption, gluten-free products, food supplements, teas and herbal infusions, legume vegetables without pods, pulses, and oilseeds and derived products.
* The analysis should include at least atropine and scopolamine and, if possible, the separate analysis of hyoscyamine enantiomers and other tropane alkaloids.
Sampling and Analysis:
* Sampling procedures should align with Commission Regulation (EC) No 401/2006.
* The preferred method of analysis is high-performance liquid chromatography mass spectrometry–mass spectrometry (HPLC-MS/MS) or, if not possible, gas chromatography-mass spectrometry (GC-MS).
* The Limit of Quantification (LOQ) for atropine and scopolamine should preferably be below 5 μg/kg (and no higher than 10 μg/kg) for agricultural commodities, ingredients, food supplements, and herbal teas; and preferably lower than 2 μg/kg for finished foods (e.g., breakfast cereals) and 1 μg/kg for cereal-based foods for infants and young children.
Investigations and Reporting:
* Member States, with food business operators, should investigate agricultural conditions leading to the presence of tropane alkaloids when significant levels are detected.
* Analytical results must be provided to EFSA regularly, with a final deadline of October 2016, using EFSA's data submission format.
Impact Analysis:
Member States:
* Impact: Required to actively monitor tropane alkaloids in specified foods and investigate the causes of their presence.
* Action Required: Conduct monitoring activities, perform investigations, and report analytical results to EFSA by October 2016.
Food Business Operators:
* Impact: Need to actively participate in the monitoring process and investigations.
* Action Required: Collaborate with Member States in monitoring efforts and investigations to identify the agricultural conditions resulting in the presence of tropane alkaloids in food.
European Food Safety Authority (EFSA):
* Impact: Responsible for receiving and processing the data submitted by Member States.
* Action Required: Provide guidance on data submission formats and analyze the data received from Member States.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Treaty on the Functioning of the European Union: One of the primary treaties forming the constitutional basis of the European Union.
European Food Safety Authority (EFSA): An agency of the European Union that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
tropane alkaloids: A group of naturally occurring toxic alkaloids found in several plant families, including Datura.
Datura stramonium: A plant species, also known as jimsonweed, that contains tropane alkaloids.
Commission Regulation EC No 401/2006: A European Commission regulation laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs.
Vytenis Andriukaitis: Member of the European Commission at the time of the recommendation.
23.6.2015 EN Official Journal of the European Union L 157/97
RECOMMENDATIONS
COMMISSION RECOMMENDATION (EU) 2015/976
of 19 June 2015
on the monitoring of the presence of tropane alkaloids in food
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,
Whereas:
(1) The Scientific Panel on Contaminants in the Food Chain (‘Contam’) of the European Food Safety Authority (EFSA)
adopted an opinion on tropane alkaloids in food and feed (1).
(2) The most studied tropane alkaloids are (-)-hyoscyamine and (-)-scopolamine. Atropine is the racemic mixture of
(-)-hyoscyamine and (+)-hyoscyamine of which only the (-)-hyoscyamine enantiomer exhibits anticholinergic
activity.
(3) The presence of tropane alkaloids in genus Datura is well known. Datura stramonium is widely distributed in
temperate and tropical regions and for this reason seeds of Datura stramonium have been found as impurities in
linseed, soybean, sorghum, millet, sunflower and buckwheat and products thereof. The Datura stramonium seeds
can not be easily removed from sorghum, millet and buckwheat by sorting and cleaning.
(4) More occurrence data are needed on the presence of tropane alkaloids in food. There is also a need to understand
the agricultural conditions under which tropane alkaloids occur in agricultural commodities.
(5) It is therefore appropriate to recommend the monitoring of the presence of tropane alkaloids in food,
HAS ADOPTED THIS RECOMMENDATION:
1. Member States should, with the active involvement of food business operators, perform monitoring for the presence
of tropane alkaloids in food, and particularly in:
— cereals and cereal-derived products, in particular (in order of priority):
— buckwheat, sorghum, millet, maize and buckwheat, sorghum, millet and maize flour,
— cereal-based food for infants and young children,
— breakfast cereals,
— grain milling products,
— grains for human consumption,
— gluten-free products,
— food supplements, teas and herbal infusions,
— legume vegetables (without pods), pulses and oilseeds and derived products.
2. The tropane alkaloids to be analysed are at least atropine and scopolamine and, if possible, to analyse the
hyoscyamine enantiomers separately and also other tropane alkaloids.
(1) EFSA Contam Panel (EFSA Panel on Contaminants in the Food Chain), 2013. Scientific Opinion on Tropane alkaloids in food and feed.
EFSA Journal 2013;11(10):3386, 113 pp. doi:10.2903/j.efsa.2013.3386.L 157/98 EN Official Journal of the European Union 23.6.2015
3. In order to ensure that the samples are representative for the sampled lot, Member States should follow the sampling
procedures laid down in Commission Regulation (EC) No 401/2006 (1).
4. The method of analysis to be used for monitoring is preferably high performance liquid chromatography — mass
spectrometry/(mass spectrometry) (HPLC-MS/(MS)) or, if HPLC-MS/(MS) is not possible, gas chromatography — mass
spectrometry (GC-MS).
The Limit of Quantification (LOQ) for atropine (racemic mixture of hyoscyamine enantiomers) and scopolamine
should be preferably below 5 µg/kg and not higher 10 µg/kg for agricultural commodities, ingredients, food
supplements and herbal teas and should preferably be lower than 2 µg/kg for finished foods (e.g. breakfast cereals)
and 1 µg/kg for cereal-based foods for infants and young children.
5. Member States, with the active involvement of the food business operators, should perform investigations to identify
the agricultural conditions resulting in the presence of tropane alkaloids in food in case significant levels of tropane
alkaloids are observed.
6. Member States should ensure that the analytical results are provided on a regular basis and by the latest by
October 2016 to EFSA in the EFSA data submission format in line with the requirements of EFSA's Guidance on
Standard Sample Description (SSD) for Food and Feed (2) and the additional EFSA's specific reporting requirements.
Done at Brussels, 19 June 2015.
For the Commission
Vytenis ANDRIUKAITIS
Member of the Commission
(1) Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official
control of the levels of mycotoxins in foodstuffs (OJ L 70, 9.3.2006, p. 12).
(2) http://www.efsa.europa.eu/en/datex/datexsubmitdata.htm