RAPID ALERT SYSTEM FOR ……… Introduction Food safety and consumer health protection is of interest to government authorities, producers, non-governmental organizations, trade organizations as well as the general public. The strategy of food safety in the European Union (EU) includes the Rapid Alert System for Food and Feed (RASFF), which is an effective tool for exchanging information between all members of the system relating to the existence of the risk to human health identified in food, feed or food contact materials. Based on information from the RASFF, prompt action and early risk prevention is possible as an essential element of food safety strategy. ….. Table 1. The members of the RASFF and their representative organizations EUROPEAN UNION European Commission Health and Consumer Protection DirectorateGeneral European Food Safety Authority (EFSA) ESTONIA Veterinaar-ja Toiduamet (Veterinary and Food Board) FINLAND Elintarviketurvallisuusvirasto Evira (Finnish Food Safety Authority Evira) FRANCE Portail de l’Economie et des Finances Direction Générale de la concurrence, de la consommation et de la répression des fraudes (DGCCRF) Ministère de l'Agriculture et de l'Agroalimentaire (Ministry of Agriculture, Food and Forestry) GERMANY Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) (Federal Office of Consumer Protection and Food Safety) GREECE Hellenic Food Authority (EFET) HUNGARY Nemzeti Élelmiszerlánc-biztonsági Hivatal (National Food Chain Safety Office) ICELAND The Icelandic Food and Veterinary Authority MAST IRELAND F.S.A.I. - Food Safety Authority of Ireland ITALY Ministero della Salute (Ministry of Health) LATVIA Partikas un Veterinarais Dienests (Food and Veterinary Service) LIECHTENSTEIN Amt für Lebensmittelkontrolle/Landesveterinäramt (Office for Food Inspection and Veterinary Affairs) LITHUANIA Lietuvos Respublikos Valstybinė Maisto Ir Veterinarijos Tarnyba (State Food and Veterinary Service of the Republic of Lithuania) LUXEMBOURG OSQCA: Organisme pour la sécurité et la qualité de la chaîne alimentaire MALTA Food Safety Commission NETHERLANDS Voedsel en Waren Autoriteit (Food and Consumer Product Safety Authority ) 1 NORWAY Statens tilsyn for planter, fisk, dyr, og Næringsmidler (Norwegian Food Safety Authority) POLAND Główny Inspektorat Sanitarny (Chief Sanitary Inspectorate) PORTUGAL Ministério da Agricultura, Desenvolvimento Rural e Pescas (MADRP) Ministério da Agricultura, do Mar, do Ambiente e do Ordenamento do Território (MAMAOT) Source: http://ec.europa.eu/food/food/rapidalert/members_en.htm Commission Regulation (EU) No 16/2011 lays down implementing rules for the RASFF to operate correctly. Special attention must be undertaken both for cases where a serious risk was identified and in relation to other cases where, although a risk of lesser gravity or urgency was identified, an exchange of information is necessary between and among the members of the RASFF network. ….. An alert notification, an information notification and a border rejection notification are recognized as an original notification. A notification that contains additional information in relation to original notification is called follow-up notification [Commission Regulation (EU) No 16/2011, RASFF Preliminary Annual Report 2013]. There are three main categories of notifications. The first category, the biggest one, concerns controls at the outer EEA borders in points of entry or border inspection posts when the consignment is not accepted for import (“border control-consignment detained”) or a sample is taken for analysis at the border (screening) and the consignment is released (“border-control consignment released”). The second category of notifications concerns products placed on the market in one of the member countries including the EEA countries (“official control on the internal market”). Market notifications include: a consumer complaint, a company notification as the outcome of its own-check or a food poisoning as the basis of the notification. The third category of notifications is related to official controls in a nonmember country, when a non-member country informs a RASFF member about a risk identified during its official controls concerning a product that may be present in the RASFF member country [RASFF Annual Report 2012]. In 2012, there were five such notifications, three originated from Canada, two were provided through INFOSAN (International Food Safety Authorities Network). In 2013, there was only one such notification provided through INFOSAN. In Tables 2 and 3, the number of all notifications in the RASFF in 2006−2013 is presented. The increase in the total number of original notifications was observed in 2006−2011, whereas since 2011, the decrease was noted (Figure 1A, Table 2). This decrease in 2013 was 8.6% in relation to 2012 and it was mostly due to the significant decrease in the number of border rejection notifications (−15.9%). Similar tendency can be seen for follow-up notifications (Figure 1B; Table 3). It may indicate on more effective border controls in the past, which eliminated dangerous products for consumers and now that the RASFF fulfill its task and less questionable products enter the territory of the European Community. Figure 1. Total number of (A) original notifications and (B) follow-up notifications in 2006−2013. 2 Total number of original notifications A 4000 3500 3000 2500 2000 1500 1000 500 20 06 20 07 20 08 20 09 20 10 20 11 20 12 20 13 20 06 20 07 20 08 20 09 20 10 20 11 20 12 20 13 0 Total number of follow-up notifications B 5500 5000 4500 4000 3500 3000 2500 2000 1500 1000 500 0 Source: Own preparation based on Annual Report 2010; Preliminary Annual Report 2013 Table 3. The number of follow-up notifications in the RASFF (20062013) Follow-up notifications Alert Border InforInforTotal Year notifirejection mation mation for cation notifinotifiatten-tion cation cation 2006 2157 923 640 3720 2007 2440 978 796 4214 2008 1789 743 1329 3861 2009 1848 732 2099 4679 2010 2051 971 2202 5224 2011 2265 1053 421 480 5345 2012 2312 906 74 663 5281 2013 2376 525 1 763 5156 Change 2013/2012 +2.8 +15.1 2.4 42.1 98.6 [%] *Without notifications which were withdrawn Source: Own preparation based on Annual Report 2010; Preliminary Annual Report 2013 ….. 1. Contaminants 3 Information for follow-up 1126 1326 1493 +12.6 The RASFF notifications are mostly related to contaminants that are defined as substances that may be present in food as a result of food production, transport or holding as well as a result of environmental contamination. It means that they are not intentionally added to food. ….. 1.1. Mycotoxins The adverse effects of mold-infected food or feed have been known for centuries but the recognition of the chemical nature and the role of mycotoxins as possible carcinogens has been the subject on intensive studies only since the early 1960s [Shibamoto, Bjeldanes 2009]. Mycotoxins are toxic secondary metabolites produced by filamentous fungi, commonly known as molds, mainly by Aspergillus and Fusarium species. Diseases resulting from the consumption of mycotoxins are called mycotoxicoses. …… Both, the peanut and cotton seed supplemented feed were contaminated by Aspergillus flavus mold. The effort was undertaken to isolate the active toxins from the fungus and the toxins were named aflatoxins [Richard 2007; Schibamoto, Bjeldanes 2009]. ….. 1.1.1. Aflatoxins ……. The structures of aflatoxins are shown in Figure 2. Another hydroxylated metabolite of aflatoxin B1, aflatoxin M1, is not a contaminant of grains. It was found primarily in animal tissues and fluids such as milk or urine [Richard 2007, Schibamoto , Bjeldanes 2009]. Figure 2. Structures of aflatoxins O O R O O Aflatoxin B1 G1 B2 G2 B2a G2a O X OCH3 R H H H H OH OH X CH2 CH2O CH2CH2 CH2CH2O CH2CH2 CH2CH2O Source: Own preparation The aflatoxins are lipid soluble and considerably stable during cooking or roasting. They are primarily hepatotoxic and cause liver damage in animals. The International Agency for Research on Cancer (IARC) classified aflatoxin B1 as carcinogenic to humans (group 1) [IARC Monographs on the Evaluation of Carcinogenic Risks to Humans]. …… Source: Own preparation Because animal and human health problems related to these mycotoxins are almost exclusively associated with the consumption of contaminated maize or products made from maize [Bolger et al. 2001; Marasas 2001], European Community regulations for fumonisins concerns maize and its products. The sum of fumonisin B1 and B2 cannot exceed 200 µg/kg 4 in processed maize-based foods and baby foods for infants and young children and 2000 µg/kg in unprocessed maize [Commission Regulation (EU) No 1881/206]. 1.1.2. Deoxynivalenol Deoxynivalenol (DON, vomitoxin or feed refusal toxin due to its strong emetic effects after consumption; Figure 5) is produced primarily by several molds of the genus Fusarium, especially by different strains of Fusarium graminearum, a common contaminant of several grains. It belongs to mycotoxins called trichothecenes of the type B [Richard 2007; CAST 2003]. The major crops affected by DON are corn, wheat, oats and barley. Swine are the animals most usually affected by this toxin. The level above 1 µg of DON/g of product is considered harmful to these animals [Richard 2007]. One of the most important physicochemical property of DON is its heat-stability, which is the risk of its occurrence in food. DON may cause short-term nausea and vomiting. Other effects include diarrhea, abdominal pain, headache, dizziness and fever [Sobrova et al. 2010]. ………….. Figure 5. The structure of DON H O OH O O OH OH Source: Own preparation deoksyniwalenol …….. 1.1.3. Mycotoxins in the RASFF notifications Since 2011, the decrease in the total number of RASFF notifications related to mycotoxins is observed (Table 6). Contamination of food with aflatoxins and ochratoxin A are the most frequently notified (Table 7). In 2010−2013, border rejections contributed more than 80% of all the RASFF notifications concerning mycotoxins. The number of alert and information for attention was usually similar and was about 710% of the total number of notifications (Table 6). Table 6. The number of notifications related to mycotoxins in 20092013 Year Alert Border Information for Information for rejection attention follow-up Change in relation to previous year [%] 2009 665 2010 47 586 46 679 +2.1% 2011 64 514 46 7 631 -7.1 2012 38 425 53 9 525 -16.8 2013 78 269 55 3 405 -22.9 Source: Own preparation based on RASFF Annual Report 2012, RASFF Preliminary Annual Report 2013 ….. 5 Total Significant decrease in the number of notifications related to aflatoxins is observed since 2009. The number of notifications for ochratoxin A is much lower than for aflatoxins and since 2010, the number of notifications is on the similar level (Figure 8 and Figure 8a; Table 7). Figure 8. The number of notifications on aflatoxins and ochratoxin A in food and feed in 20022012 1000 Aflatoxins Total number of notifications 900 800 700 600 500 400 300 200 100 20 02 20 03 20 04 20 05 20 06 20 07 20 08 20 09 20 10 20 11 20 12 0 Source: Own preparation based on RASFF Annual Report 2011, RASFF Annual Report 2012 Figure 8a. The number of notifications on aflatoxins and ochratoxin A in food and feed in 20022012 60 Ochratoxin A Total number of notifications 50 40 30 20 10 20 02 20 03 20 04 20 05 20 06 20 07 20 08 20 09 20 10 20 11 20 12 0 Source: Own preparation based on RASFF Annual Report 2011, RASFF Annual Report 2012 Most of notifications on mycotoxins were usually related to: nuts, nut products and seeds (e.g. 515 in 2009, 204 in 2012), fruits and vegetables (e.g. 68 in 2009, 157 in 2012), feed (e.g. 9 in 2009, 79 in 2012), herb and spices (e.g. 34 in 2009, 37 in 2012), cereals and bakery products (e.g. 21 in 2009, 34 in 2012). These products originated from such countries as India, Argentina, China, Turkey, USA and Iran [RASFF Annual Report 2009; RASFF Annual Report 2012]. 1.2. Heavy metals 6 ….. Therefore, the main source of human exposure to heavy metals is contaminated food, and water. Heavy metals can bind to proteins, enzymes, and nucleic acids changing their functions and causing adverse health effect [Landis, Yu 1999]. Among the many heavy metals, lead (Pb), cadmium (Cd), and mercury (Hg) have been recognized as the most toxic. Their maximal levels, and also tin (Sn), in food are regulated by the European Commission [Commission Regulation (EC) No 1881/2006 with further amendments]. ….. Mercury compounds cause neuromuscular and neurological defects including loss of sensation, loss of coordination and hearing, slurred speech (so called Minamata disease). Pregnant women exposed to methyl mercury gave birth to infants with severe psychomotor signs of brain damage and cerebral palsy. Later symptoms included progressive deafness, blindness, lack of coordination and mental deterioration [Shibamoto, Bjeldanes 2009]. ….. 1.3. Dioxins and dioxin-like compounds ….. PCDDs are derivatives of dibenzo-p-dioxin. There are 75 dioxin derivatives (congeners) differing only in the number and position of chlorine atom. PCDFs are derivatives of dibenzofuran. There are 135 congeners of PCDF (Figure 9). Toxicity of dioxins and PCBs is expressed in toxicity equivalent factor (TEF). The most toxic is 2,3,7,8-tertachlorodibenzop-dioxin (TCDD) for which TEF was established as 1. Figure 9. The structure of PCDD, PCDF and PCB O nlC O Cln nlC Cln Cln nlC O PCDD PCDF PCB Source: Own preparation Dioxins and PCBs are toxic due to their (1) irreversible chemical reactivity in binding to important macromolecules such as DNA, (2) reversible reactivity to specific sites in receptors and enzymes, and (3) accumulation in lipid-rich cellular components [Landis, Yu 1999]. They may damage the immune system, interfere with hormones (estrogenic compounds), cause reproductive and developmental problems, and also cancer. In 1997, based on animal data and on human epidemiology data, the IARC classified TCDD as known human carcinogen (1 group) [IARC Monographs on the Evaluation of Carcinogenic Risks to Humans]. However, TCDD does not affect genetic material and there is a level of exposure below which cancer risk would be negligible [WHO 2010]. 1.4. Melamine 7 Melamine is aromatic amine having a number of industrial uses, including the production of melamine resins, laminates, glues, coatings, flame retardants, adhesives, and molding compounds. Melamine is a name used both for the chemical compound and for the plastic made from it. Due to the high content of nitrogen, melamine has been illegally added to food and feed to elevate the level of proteins. In 2008, in China there was a mass poisoning of children, caused by melamine added to milk powder to overestimate the protein content in this product. In 2012, there were 3 notifications on the melamine content in dog food. Melamine can migrate in wet pet food from the can coating at a level above 2.5 mg/kg relative to a feed with moisture content of 12% but below the Specific Migration Limit (SML) of 2.5 mg/kg in the wet pet food. EC has established the maximum level of 2.5 mg/kg for canned wet pet food on a ‘as sold’ basis [Commission Regulation (EU) No 107/2013]. In food, the melamine content cannot be higher than 1.0 mg/kg (in powdered infant formulae and follow-on formulae) and 2.5 mg/kg in other food [Commission Regulation (EU) No 594/2012]. Conclusion The RASFF is an important element of consumer protection system in the European Union. It enables immediate action when danger occurs and allows rapid elimination of hazardous to health products from the European Union. It also provides a uniform level of food safety throughout EU territory. Every year, a hundreds of notifications are registered in the RASFF and appropriate actions are undertaken to protect consumer against dangerous food. The bases for notifications identified every year are border controls, official controls on the market and company’s own check. The RASFF notifies also cases of consumer complaint and cases of food poisoning. A non-member country (the third country) can also inform a RASFF member about a risk found during official controls concerning food or feed that may be on the market in one of the member countries. On the other hand, the European Union must inform a third country if a product subjected to a notification has been exported to that country. Therefore, the RASFF system can be considered as a global system informing about a serious health risk derived from food, feed, and food contact materials. References: 1. Afshar, P., Shokrzadeh, M., Kalhori, S., Babaee, Z., Saeedi Saravi, S.S., 2013, Occurrence of ochratoxin A and afatoxin M1 in human breast milk in Sari, Iran, Food Control, vol. 31, 525–529. 2. Bolger, M., Coker, R.D., DiNovi, M., Gaylor, D., Gelderblom, W.C.A., Olsen, M., Paster, N., Riley, R.T., Shephard, G., Speijers, G.J.A., 2001, Fumonisins. Safety Evaluation of Certain Mycotoxins in Foods, FAO Food and Nutrition Paper 74. World Health Organization, Geneva, pp. 103-279. 3. CAST, 2003, Mycotoxins - risks in plant, animal and human systems, Task Force Report, No. 139. Council for Agricultural Science and Technology, Ames, Iowa, p. 1–191. 4. Chmielnicka, J., 2002, Toksyczność metal i półmetali (metaloidów) w: Seńczuk, W. (ed.), Toksykologia Współczesna, Wydawnictwo Lekarskie PZWL, Warszawa, p.360–446. 5. Clark, H.A, Snedeker, S.M., 2006, Ochratoxin A: its cancer risk and potential for exposure, Journal of Toxicology and Environmental Health. Part B, Critical Reviews, 9 (3), 265–296. doi:10.1080/15287390500195570. PMID 16621780. 6. Commission Regulation (EC) No 16/2011 of 10 January 2011 laying down implementing measures for the Rapid alert system for food and feed, Journal of the European Union, L 6/7-L 6/10. 7. Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs, Official Journal of the European Union, L 364/5-L 364/24. 8 8. Commission Regulation (EC) No 277/2012 of 28 March 2012 amending Annexes I and II to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels and action thresholds for dioxins and polychlorinated biphenyls, Journal of the European Union, L 91/1-L 91/7. ….. mgr Jan Kowalski Poznań University of Economics 9