Food & Feed Analysis I/2017. Gluten-free food: Standards and regulations you should know about

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1 R-Biopharm news Food & Feed Analysis I/2017 Gluten-free food: Standards and regulations you should know about Producers of gluten-free food must comply with certain requirements in terms of labelling, manufacturing and analysis. From Codex Alimentarius to the AOECS standard and EU regulations: We have summarized the existing legislations and recent resolutions you should be aware of in Codex Alimentarius The Codex Alimentarius is a collection of standards for food safety. It is jointly developed by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) with the objective to ensure consumer protection. The document is based on scientific knowledge and contains regulations for different aspects of food safety, including toxins, supplements, residues, microorganisms, GMO and food allergens. The standards laid down in the Codex Alimentarius are recommendations and not legally binding; however, many national laws are based on the Codex standard. The document CODEX STAN : Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten is of particular interest to producers of gluten-free food. Among other things, the standard defines limit values for gluten. Accordingly, a product may only be labelled as gluten-free if it contains no more than 20 mg/kg gluten. Products containing more than 20 but less than 100 mg/kg gluten may be labelled as very low gluten. At the beginning of December 2016, the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), a board of the Codex Alimentarius Commission, met in Hamburg, Germany. continued on page 2 R-Biopharm for the safety of your analysis.

2 R-Biopharm AG continued from page 1 An important decision in the official report: The analysis method to be used for the detection of gluten is an ELISA test based on the R5 antibody (such as RIDASCREEN Gliadin, Art. No. R7001). Use of a G12 ELISA is not recommended due to the lack of comparability until further notice. RIDASCREEN Gliadin, Art. No. R7001 AOECS The AOECS (Association of European Coeliac Societies) is the European umbrella organization of national coeliac societies. Its member societies are licensing the use of the trademarkprotected Crossed Grain symbol. Manufacturers that wish to use this symbol must sign a licensing contract. This will require high production standards and regular analyses proving that the products are gluten-free. Not all products can use the Crossed Grain symbol. In order to protect consumers from misleading claims, unprocessed foods which are free from gluten by nature, cannot use the gluten-free symbol. This includes, for example, fresh fruit and vegetables as well as eggs and milk. The AOECS regularly publishes the AOECS Standard for Gluten-Free Foods, which defines the technical requirements for the licensing of the Crossed Grain symbol. For example, it contains HACCP guides and statements on the analysis method to be used for the detection of gluten. In the current edition of the standard (September 2016), the AOECS requires the use of a sandwich ELISA based on the R5 antibody for gluten analysis (such as RIDASCREEN Gliadin, Art. No. R7001) in accordance with the Codex standard. For the detection of gluten in fermented or hydrolyzed foods, an R5 competitive ELISA has to be applied (such as RIDASCREEN Gliadin competitive, Art. No. R7021). In addition, a lateral flow test based on the R5 antibody can be used for rapid in-house hygiene control (such as RIDA QUICK Gliadin, Art. No. R7003, R7004, R7005). EU regulations EU regulations are mandatory for all manufacturers which sell their products in the EU. The following laws must be observed: Food Information Regulation (LMIV)/EU regulation No. 1169/2011: This resolution stipulates that information on potential allergens must always be provided to the consumer even when the food is offered unpacked, for example in restaurants or bakeries. Previously, allergens had to be labelled only on packaged food. EC regulation No. 41/2009: An important point in this document is the specification of Europe-wide binding limit values for labelling products as gluten-free or very low gluten. It adopts the limit values defined in the Codex standard. Implementing regulation No. 828/2014: This regulation became effective on 20 th July, 2016 and replaces regulation No. 41/2009. The paper now also contains rules concerning the use of the claims suitable for people intolerant to gluten/ coeliacs and specifically formulated for people intolerant to gluten/coeliacs. page 2

3 New products Optimized RIDASCREEN Chloramphenicol The use of the broad-spectrum antibiotic chloramphenicol (CAP) for food-producing animals is prohibited throughout the EU and in many other countries. As CAP has excellent antibacterial and pharmacokinetic properties and can also be cheaply produced, it is used throughout the world in spite of this. Residues of chloramphenicol can also have other undesirable effects, which can cause damage to the bone marrow and potentially lethal pancytopenia (anaemia) in consumers. In order to ensure the protection of consumers, Minimum Required Performance Level, MRPL have been introduced for residue control tests. These are 300 ng/kg for all of the matrices which are examined. The newly developed test, RIDASCREEN Chloramphenicol (Art. No. R1511), is a competitive enzyme immunoassay (ELISA) for the quantitative analysis of CAP in milk, milk powder, dairy products, honey, meat, fish, shrimp, eggs, urine, plasma/serum and animal feeds. This new test will replace the previous RIDASCREEN Chloramphenicol test (Art. No. R1505), when the product stock is sold out. In contrast to the previous test, the new CAP test offers a whole series of improvements: Due to the reduction of the total incubation time to 45 minutes and the provision of all reagents as ready-to-use solutions, examination of samples is now considerably quicker and simpler. The wide spectrum of analysed matrices (including for the metabolite chloramphenicol-glucuronide in urine), as well as improved sensitivity, enables reliable examination of CAP in a variety of samples. Detailed information (comparison of the old and the new test, validation report, etc.) is available on request. Please contact your local distributor. RIDASCREEN Chloramphenicol, Art. No. R1511 RIDA SMART APP Analyser SET The new RIDA SMART APP Analyser SET (Art. No. ZRSAM1000-SET) contains everything needed for the mycotoxin analysis in one complete package. The RIDA SMART APP Analyser SET (Art. No. ZRSAM1000-SET) contains the license for the App, a Nexus 6P smartphone and the smartphone stand. RIDA SMART APP Analyser SET, Art. No. ZRSAM1000-SET page 3

4 Our products Changes in RIDA STAMP product line The RIDA STAMP products Vibrio (Art. No. HS0311/HS0312), RIDA STAMP Cereus (Art. No. HS0351/HS0352) and RIDA STAMP Staph (Art. No. HS1791/ HS1792) are being discontinued. As an alternative, the appropriate Compact Dry plates can be used in connection with the Compact Dry Swab (Art. No. ZCS ). The 50 unit package of RIDA STAMP Salmonella (Art. No. HS0391) and RIDA STAMP S. aureus (Art. No. HS0461) will no longer be produced. The smaller kits with 25 units are still available. Information from R-Biopharm Rhône, Scotland Trichothecenes: Optimize your mycotoxin analysis with multi-analyte testing Mycotoxin detection is a challenge to many farmers, food producers and laboratories. On the one hand, the matrices to be tested are often very complex; for example animal feed is difficult to analyze since the exact composition is often unclear. On the other hand, mycotoxin analysis poses a problem since there is a large number of mycotoxins that might be present in the product. One group of mycotoxins which is particularly relevant are the trichothecenes. These are mainly produced by molds of the Fusarium genus and are frequently found in cereals. Trichothecenes are classified into four subgroups (type A to D) according to their chemical structure with types A and B being the most relevant. Important toxins within the group are T-2, HT-2, DON and Nivalenol. Analysis of trichothecenes in a single run can be performed by GC or more commonly by LC-MS/MS. These methods require some sample clean-up and solid phase extraction (SPE) columns are generally favored. R-Biopharm can provide a number of SPE columns for the detection of trichothecenes in a single LC-MS/MS run. PuriTox Trichothecene (Art. No. TC-T220) PuriTox DON/NIV (Art. No. TC-C210) TRICHOTHECENE P columns (Art. No. RBRP51) Test format Syringe format SPE Gravity flow SPE Test tube SPE Detection GC or LC-MS/MS GC or LC-MS/MS GC or LC-MS/MS Advantages One sample preparation for simultaneous detection of 9 trichothecenes Easy-to-use format therefore are quicker and easier to work with One sample preparation for simultaneous detection of 9 trichothecenes Used with vacuum manifold One sample preparation for simultaneous detection of 9 trichothecenes page 4

5 R-Biopharm AG Official methods: Immunoaffinity columns for vitamin analysis In many countries around the world, there are prescribed methods of food analysis, where the legal basis for food control is that all laboratories should follow a dispute resolution method in cases of disagreement of results. These official methods have invariably been tested by an inter-laboratory validation study to demonstrate that different laboratories using different equipment can achieve comparable results when analysing the same samples. These inter-laboratory studies are based on the results from a minimum of eight different laboratories and establish the method performance in terms of the recovery, precision and limits of detection and quantification. These parameters are known as the method performance characteristics, and indicate the performance that any laboratory can expect to achieve when closely following the method. The most widely known Official Methods are those of AOAC International and ISO, and the European Committee for Standardization (CEN) standards. At the AOAC International meeting in Dallas, September 2016 the Expert Review Panel (ERP) for the Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) awarded Final Action Status to method entitled Vitamin B12 in Infant Formula and Adult/Pediatric Formulas Ultra-High- Performance Liquid Chromatography. The immunoaffinity column used in the Multi Lab Trial (MLT) organized by Nestec Centre de recherches Nestlé (Lausanne, Switzerland) was EASI-EXTRACT VITAMIN B12 (LGE) supplied by R-Biopharm Rhône. The data from the MLT met the specifications laid out in SMPR for Vitamin B12 in Infant Formula and Adult/Pediatric Nutritional Formula. At the AOAC International mid-year meeting in Gaithersburg 2016 the Expert Review Panel (ERP) for the Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) awarded First Action AOAC approval to method entitled Determination of Biotin by Liquid Chromatography Coupled with Immunoaffinity Column Clean-up. The immunoaffinity column used in the Single Lab Validation (SLV) performed by AsureQuality (Auckland New Zealand) was EASI-EXTRACT BIOTIN supplied by R-Biopharm Rhône. The data from the SLV met the specifications laid out in SMPR for determination of biotin in Infant Formula and Adult Nutritionals. In addition method was selected for Multi Lab Trial (MLT) to generate the required data to support progress of the method to Final Action Status. EASI-EXTRACT VITAMIN B12 (LGE), Art. No. RBRP88/RBRP88B page 5

6 RIDASOFT Win/RIDASOFT Win.NET Art. No. Z9996 Since RIDASOFT Win is an obsolete version with respect to the current PC software and is no longer in line with current requirements, maintenance will no longer be available after version There will also be no more updates for RIDASOFT Win after this version. Maintenance will still be provided for the RIDASOFT Win.NET (Art. No. Z9996), and the software can run both on 32 and on 64 bit systems, but only from Windows XP - Service Pack 3. This software is suitable for measuring, analysis, and documentation of the RIDASCREEN ELISA and also adapted to other R-Biopharm tests. A selection of addressable microtiter plate READERs is available upon request. Please contact your local distributor. Current version: 1.98 If you are interested in an update of RIDASOFT Win.NET, please contact your local distributor. If you are interested in our products, please contact your local distributor. Fairs and conferences IAFP S European Symposium on Food Safety Brussels, Belgium nd Food Allergen Management Symposium FAMS 2017 Sydney, Australia Food Safety Supply Chain Conference Rockville, USA Free from Food Expo Barcelona, Spain th Mycotoxin Workshop 2017 (Society for mycotox.research) Bydgoszct, Poland Analysts workshops R-Biopharm AG 2017 Title Date Real-time PCR (Basic workshop) Antibiotics (ELISA/IAC/HPLC) Mycotoxins (ELISA/LFD/IAC/ Automation) Allergens (PCR/ELISA/LFD/ Automation) Microbiology Pathogens (ELISA/PCR/Automation) Vitamins (HPLC/VitaFast / RIDASCREEN ) Enzymatic General information: The number of participants for the workshop is limited. Communication language will be English. Workshop fee will be EUR + 19 % VAT More information and registration: Web-based workshop brochure "Analysts workshops R-Biopharm AG 2017" at or International Sales Department Phone: Fax: sales@r-biopharm.de All workshops will take place in Darmstadt. The next R-Biopharm news will be published in the II nd quarter R-Biopharm news is edited by R-Biopharm AG An der neuen Bergstraße Darmstadt, Germany Reg.-No.: Amtsgericht Darmstadt, HRB 8321 Phone: Fax: info@r-biopharm.de