A complicated question, but even partial answers are wellcome:
What is the legal liability for people, who are developing or commercially resp. non-commercially administering the analytical methods for the detection of food allergens? I mean the legal aspects of analytical methods, which are used to enforce the existing worldwide law on listing the food allergens on food packages. I am most interested in DNA-based methods. If an analytical method is not good or has a flaw, who takes legal responsibility for potential problems? The producer of problem-causing food, the inventor of the method, or the facility which does the testing? If there are standards (norms) published by ISO or CEN or other institutions, are they actually a law, or just expert recommendations? There is a European standard "EN 15842:2010 Foodstuffs - Detection of food allergens - General considerations and validation of methods (European Commitee on Standardization, 2010)". If I develop / want to commercially perform a new method for use in EU, must I validate it according to this European standard, or is it only a voluntary enterprise, which I can brag about, but am not obligated to do? Is there a review article on these issues? Partial answers (e.g. only your country outside EU, anecdotal experiences at the legal court etc) are also appreciated.
The book does not seem to address legal issues. At least text search with words like law, directive, legal etc. does not lead me to relevant sections. However, the book will be probably useful for other questions in my field, so thank You.
I will probably edit the question to make more clear, that it is about legal aspects.
Thank you Barbara for your question. I am definitely not competent to reply, but have been at a conference in London today organised by the Laboratory of the Government Chemist. I will circulate your question with my co-author Michael Walker and his colleagues and get back to you with any reply.
@ Ms. Hazel Gowland - thank You !
@ All - I have a partial answer.
The CEN European standards only by themselves are not a law. However, there are cases, when these European standards are mentioned or incorporated into the Directives of European Union, and this way they can become a law. The example I gave in my question, i.e. EN 15842:2010 is so far not incorporated into EU law, at least to the best knowledge of my colleague next door.
Just curious.... PCR detects DNA. Allergens are not DNA, and although allergens are derived from sources that possess DNA, I would suppose allergens can be present without their source DNA being present? So wouldn't a PCR used to detect an allergen source (as indirect detection of allergen) be liable for false negative results?
You are right it is an indirect method, because the proteins are responsible for allergic reaction, not DNA. But in some cases, where sufficient amount of DNA tends to accompany proteins, it is O.K. to use this indirect method, while sometimes it is not.
There is a nice ppt presentation about it. It says, for example, that nuts are O.K. to detect by PCR for allergenic issue, while eggs are not:
http://www.achipia.cl/prontus_achipia/site/artic/20130805/asocfile/20130805143821/food_allergen_detection_methods___bert_popping.pdf
Dear Barbara
We treat this in Switzerland (not member of EU) like the following, roughly:
We are accredited and are allowed to develop new methods. After full validation this method is in the accredited scope and may be used to judge Food products. If we find a product containing not declared allergens, the supplier has to prof us ether that this is not the case, using his regular control measurements or he has to correct the declaration. So the method is just the beginning and cannot reflect the true Situation. If the supplier can Show that our measurement was false, we take back our contestation inclusive the invoice. At the end of the day we are responsible. But a single measurement cannot show a statistical valid true Situation. But on the other hand we cannot test so far, Otherwise costs and effort would explode with our increasing the food safety.
I hope I could explain what we do
Best regards
René Köppel
Food forensics is a brand new branch of the science of food safety. At the moment there are no obvious legal issues restricting or surrounding any method. However, your perspective is an interesting one to keep in mind and would be an important element in the formulation of laws relating to popular analytical methods or the role of chemical analysts and cooks.
Dear Barbara, a new test in medicine is what nowadays health managers and policy-makers call a health technology. The best way to implement it is after a complex multidisciplinary process called health technology assessment. An important but still part of it is to find high quality evidences for the efficacy of that the test. There is a way to do that - validation of the new method against the accepted gold standard. In your case you can find information about these standards in the corresponding EU Regulation you mention about. Having done that health technology assessment process deals with economic, legal, social and ethical issues in regard to that method. In that way you can have a full picture of advantages and shortcomings of your test. Then these data are presented to the governmental body authorized to take health policy decisions. Only then implementation can be without legal issues.
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