I. Introduction [631462]

I. Introduction
In her opening speech, held in Brussels on 16 July
2009 on the occasion of the Conference regardingthe 30 years of RASFF that had been organised byDG Health & Consumers, the Commissioner,responsible for Health, Mrs Androulla Vassiliou,pointed out that the “ Rapid Alert System for Food
and Feed is a crucial tool for ensuring food safety inEurope ” by explaining that this Alert System “ has
grown over a period of 30 years into a highly valuedinstrument that its operators use to exchange infor-mation, in real-time, about actions they have taken toensure food and feed safety .”
1As we know, the
Rapid Alert System for Food and Feed (in the fol-lowing: RASFF) enables information to be sharedrapidly and efficiently between the European Com-mission, the official food and feed control authori-ties in the Member States, the European FoodSafety Authority (in the following: EFSA) and otherorganizations whenever a health risk has been iden-tified. Hence, this system allows safety measures to
be adopted quickly, efficiently and in a coordinatedmanner, in order to avert food safety risks beforethey can harm consumers. Indeed, by facilitatingthis system to have a swift exchange of informationbetween its members, the RASFF has become a fun-damental tool for guaranteeing a high level of pro-tection of human health and consumers’ interest inrelation to food and feed; which is one of the mainobjectives of the European Food Law (see Article 130 Years of the Rapid Alert System for Food and Feed 10
* Prof. Dr. Bánáti, Diána is Chair of the EFSA Management Board;
Director General of the Central Food Research Institute inBudapest and Professor and Chair of the Budapest Corvinus Uni-versity and the Szent István University. Contact: [anonimizat].
** Dr. Barbara Klaus, Solicitor and Partner of the renowned Law Firm
meyer//meisterernst, Milan, Italy (www.meyermeisterernst.com)and Teacher at the European Institute of Public AdministrationAntenna Luxembourg, European Centre for Judges and Lawyers(Master of European Legal Studies).
1 The speech of Commissioner Mrs Androulla Vassiliou can be
downloaded on the Website: http://ec.europa.eu/food/food/rapi-dalert/rasff_30_feedback_en.htm.EFFL 1|2010
30 Years of the Rapid Alert System for Food
and Feed
An overview on the European Alert Network, combined with a case study
on melamine contaminated foods
Diána Bánáti* and Barbara Klaus**
In 2009, the Rapid Alert System for Food and Feed (in short: RASFF) celebrated 30 years
of existence within the European Union. This European Alert Network has evolved to oneof the most important safety tools in the Food and Feed sector and it is therefore oftenpresented as one of the great success stories of the EU’s integrated approach to food safe-ty. Having the significance of this mechanism in mind, in order to ensure a high level ofHealth Protection, this Article provides an overview of the legal basis of the Rapid AlertSystem for Food and Feed and shows how this System functions in the practice; it alsotraces the history of this System from its beginnings and gives a vision how it may devel-op over the coming years. Moreover, is demonstrated that in the melamine poisoningcase, where a plastic substance had been added to milk and milk powder by a Chineseproducer in order to imitate a higher protein level, the European Rapid Alert System hadproven how efficient it was; just as the safety measures that have been undertaken in thiscase, it started with a news flash from the RASFF. Hence, a case study on melamine con-taminated foods has been incorporated into the present Article. EffL 1-10 11.02.2010 13:24 Uhr Seite 10

30 Years of the Rapid Alert System for Food and Feed
of Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January 2002laying down the general principles and require-ments of food law, establishing the European FoodSafety Authority and laying down procedures inmatters of food safety
2). Due to the importance of
this European Alert System, the basic rules of itsfunctioning have been laid down in the EuropeanGeneral Food Law (see Articles 35 and 50 ff. of Reg-ulation (EC) No 178/2002). In recent years, RASFFhas proved itself to be an effective tool for keepingfood and feed safe, not only within the EU, but alsoin other countries. In fact, the ultimate goal ofRASFF is to create a vision beyond boundaries, byworking on a global scale and setting up a world-wide functioning Alert System in the food sector; inorder to ensure food safety and through this, to pro-tect people, across the globe; as the following expla-nations will demonstrate.
II. Short overview on the evolution
of the European Alert System
The establishment of the first European Alert Sys-
tem can be traced back to 1979; when – following a“food crisis ” induced by mercury contaminated
oranges from Israel – the EU Member States beganto set up a system to inform each other in cases of arisk to human health following food-related prob-lems. As Olga Demine, who worked at the EuropeanCommission and who was a previous member of
the RASFF-Team, remembered
3: “In the beginning,
the system was really small. There were only one ortwo people from the Member States and three fromthe Commission; we were an efficient team ”. What
happened that time? Mercury was found in severalMember States in oranges imported from Israel.This case is storied under the slogan “ Orange terror-
ism”; as an extremist group (“ Arab Revolutionary
Army-Palestine Command ”) claimed it had contami-
nated the oranges with the aim of destroyingIsrael’s economy. Besides the economic impact (theMember States banned imports), this case damagedconsumers’ confidence regarding the safety of theirfood. In order to eliminate these concerns, theMember States’ food control authorities met on 13February 1979 and the idea to construct a rapidalert system was born. Following this, first stepstowards a legal basis for RASFF were taken: As animmediate measure, and until formal Rules couldbe adopted, Belgium, Denmark, France, Germany,Ireland, Italy, Luxembourg, the Netherlands and theUnited Kingdom agreed to set up a system ofmutual information in cases where there was a riskto human health due to a problem concerning food.The intention was to create a system which enablesthem to tackle any issue that arose and which wasflexible and free from formalised rules. In order tomake this spontaneously created, non-formal AlertSystem function, its members, besides determiningthe competent national authority responsible forfood safety and creating laboratories for the controlof foodstuffs, they set up contact points, both atnational level in the Member States and in the Euro-pean Commission, responsible for transmitting andreceiving notifications to and from the Commis-sion. As in the beginning, all communications weremade by telephone, no written record has sur-vived
4. Nevertheless, the first notification within
this non-formal Alert System was induced in 1979by spoiled calamari; where the European Commis-sion called the contact points in each Member Stateto tell them about the issue and what measures hadbeen taken to protect consumers
5.
In order to have this voluntary Alert System
based on formal Rules, the European Commissionworked out a “ Proposal for a Council decision intro-
ducing a community system for the rapid exchangeof information on dangers arising from the use ofconsumers products ” which was published in De-
cember 1979
6; and finally adopted in March 19842 OJ L 31, 1.2.2002, p. 1. This Regulation is commented by A.H.
Meyer/R. Streinz, LFGB – BasisVO. Lebensmittel- und Futtermit-telgesetzbuch. Verordnung (EG) Nr. 178/2002, München 2007.
3 See p. 11 of the RASFF Booklet entitled “ 30 years of keeping
consumers safe ”, published in 2009 by the DG SANCO, Office for
Official Publications of the European Communities, ISBN: 978-92-79-12224-8; available also on the Website: ec.europa.eu/food/food/rapidalert/docs/rasff30_booklet_en.pdf.
4 In the beginning, a direct line installed in the relevant “Food
Products” service at the Commission, as well as the telex link,were used by the contact point in each Member State to sendinformation directly to the Commission. The Commission thenevaluated the information received and was able to automaticallytransmit the message to the other contact points. Only in 1992 didthe fax replaced telex in the transmission; which had an importantimpact on the system’s efficiency and effectiveness. Finally, in2000, RASFF made the shift from fax to CIRCA, an email-basedtransmission system, a technology which allows notifications tobe transmitted quickly and to a greater number of contacts. Thefuture planning is a direct notification to an Internet-platform withrestricted access for the members of the network. See also p. 15,19 and 24 of the RASFF Booklet, cited above in footnote 3.
5 See p. 13 of the RASFF Booklet, cited above in footnote 3.6 COM/79/725final; OJ C 321, 22.12.1979, p. 7.EFFL 1|2010 11EffL 1-10 11.02.2010 13:24 Uhr Seite 11

(see Council Decision No 84/133/EEC of 2 March
1984 introducing a Community system for therapid exchange of information on dangers arisingfrom the use of consumer products
7). This first for-
mal Alert System comprised both of food and non-food products; but was restricted to products whichpresent a “ serious and immediate risk … for the
health or safety of consumers when used in normaland foreseeable conditions ” (see Article 1 of Council
Decision No 84/133/EEC). Hence, at the beginning,RASFF was used as “ short-term surveillance ”; in
order to manage serious and immediate dangers.One of the problems of its adequate application inpractice has turned out to be that the above men-tioned Decision No 84/133/EEC didn’t define what a“serious and immediate danger ” would be. Hence,
the early food network remained characterised byits great flexibility; which led to legal uncertainty.In this regard, attention should be given to the factthat, at that time, the main goal of the Alert Systemwas not only to protect consumers’ health, but theemphasis was to avoid unnecessary barriers to trade(a Directorate-General dedicated to health and con-sumers did not exist in those days; DG Health andConsumer Protection’ – known as DG SANCO – wascreated only in 1997).
Following the Commission report to the Council
of the European Union on the “ Rapid exchange of
information on dangers arising from the use of con-sumer products ” in 1989, it was decided to continue
the system; by adopting the Council Decision No89/45/EEC
8. Nevertheless, the number of notifica-
tions rose only slowly and in 1992, notificationswere still at the 10-per-year mark. Yet, the year 1992marked a significant turning point for the evolutionof the Rapid Alert System. With the creation of theEU internal market in 1992, food safety becameeven more of an “ European issue ” as the internal
frontiers had been abolished, in order to ensure freemovement of goods (and persons, services and capi-tal, see Article 14 of the EC Treaty
9). As a conse-
quence, the Rapid Alert System for food wasincluded for the first time in Council Directive92/59/EEC of 29 June 1992 on general productsafety
10together with the Rapid Alert System for
non-food products (so called RAPEX; now regulatedby Directive 2001/95/EC
11). Hence, during the
1990s, the Rapid Alert System for food improved;as the national contact points allowed RASFF tohave a single dedicated organisation to contact incase of a serious alert, greatly reducing the timeneeded to address such alerts. Furthermore, in order
for Member States and their contact points to beable to correctly apply the System, the Commissiondeveloped priorities and methods of operation forthe RASFF (for instance, a RASFF “ vademecum ”
12
was published in 1998, in order to ensure that
national contact points had the necessary tools toapply the System). The rapid alert system for foodhas been successfully applied in several cases offood contamination,. For instance, in 1998, whenhigh amounts of aflatoxins in pistachios importedfrom Iran were discovered, imports of nuts contain-ing contaminated pistachios into the EU werequickly stopped by this System; The EuropeanCommission adopted a safety measure allowingimports only provided that all nuts underwent adouble-check process on arrival at the EU bordersand were certified as being aflatoxin-free. Thismeasure is still in place today; and it has beenextended in order to cover other foodstuffs whererisk of the contamination by aflatoxins exists
13.
Nevertheless, the food crisis faced by the EU in
the 1990s showed also the “ loopholes ” of that Alert
System; which finally turned out not to be able toensure effectively a high level of protection. First ofall, this was due to the fact that it only focused onfood manufacturing and not on the further stagesof processing and distribution of food, where foodsafety issues may occur as well. Furthermore, dur-ing the Bovine Spongiform Encephalopathy (BSE)crisis that struck the UK in 1995 and during the1999 dioxins crisis in Belgium, the Rapid Alert Sys-tem set out in Council Directive 92/59/EEC could30 Years of the Rapid Alert System for Food and Feed 12
7 OJ L 70, 13.3.1984, p. 16.
8 Council Decision No 89/45/EEC of 21 December 1988 on a
Community system for the rapid exchange of information ondangers arising from the use of consumer products; OJ L 17 ,21.1.1989, p. 51.
9 See also Commentaries on EC-Treaty Articles: Rudolf Streinz,
EUV/EGV, Beck Verlag, München, 2003.
10 OJ L 228, 11.8.1992, p. 24: then repealed by Directive
2001/95/EC of the European Parliament and of the Council of3 December 2001 on general product safety, OJ L 11, 15.1.2002.
11 See reference in footnote No 10. 12 EU Working Document „ Criteria for notification to the RASFF “
of 28.5.2003.
13 See Commission Regulation (EC) No 1152/2009 of 27 November
2009 imposing special conditions governing the import ofcertain foodstuffs from certain third countries due to contamina-tion risk by aflatoxins and repealing Decision 2006/504/EC); OJ L 313, 28.11.2009, p. 40. With regards to the Principle of riskanalysis in general, see A.H. Meyer, Risk Analysis in accordancewith Art. 6, Regulation (EC) No. 178/2002, EFFL 2006, p. 146;M.A.R. Girela, EFFL, 2006, p. 270.EFFL 1|2010EffL 1-10 11.02.2010 13:24 Uhr Seite 12

30 Years of the Rapid Alert System for Food and Feed
not adequately been applied; due to the fact that at
that time, the System did not cover live animals norfeed. Hence, these food crises have demonstratedthe limits of the former Rapid Alert System and – atthe same time – they served as a turning point, notonly for the EU’s entire food safety policy, but alsofor the safety procedures, including the Alert Sys-tem. The Commission recognized the urgent needto set up an improved and broadened Rapid AlertSystem covering food and feed; in compliance withthe Commission’s overall “ farm to fork ” policy. For
this reason, both the legal basis and a formalizedprocedure for a specific RASFF-System applying tofood and feed, have been included, in 2002, into theGeneral European Food Law (see recital 59 and Arti-cles 35 and 50 of Regulation (EC) No 178/2002). Inaddition, the European Food and Feed SafetyAuthority (EFSA) was established by the Regulation(EC) No 178/2002; as an independent point of refer-ence for risk assessment and source of scientificadvice and communication on risks related to the
food chain. Hence, as we will see
14, EFSA plays a
key role in this new RASFF-System. Since the intro-duction of this System in 2002, the number of noti-fications has been steadily increasing: in 2002, itexceeded 3000, which was a rise of ca. 330% fromthe level of 1999 (698) and a near-doubling of thenumber in 2001 (1567); and it continued to grow inthe following years reaching 4414 in 2003 and 5562in 2004 up to 7170 in 2005); it now has settled toapprox. 7000 notifications per year
15. Moreover, an
important aspect of the RASFF System is, that itforesees procedures for providing information alsoto third countries, for instance for products origi-nating from their territories, which gives thesecountries the possibility to solve the safety prob-lems at home. The functioning of the RAFFS will bedescribed in the following Chapter.
III. Legal basis and functioning
of the RASFF16
The information flow of the RASFF system is
shown in Fig. 1 14 See Chapter III.
15 See p. 27 f. of the RASFF Booklet, cited above in footnote 3.16 See also the RAFFS leaflet available on Internet:
http://ec.europa.eu/food/food/rapidalert/docs/rasff_leaflet_en.pdf.EFFL 1|2010 13
Source: http://ec.europa.eu/
food/food/rapidalert/about_rasff_en.htm)EffL 1-10 11.02.2010 13:24 Uhr Seite 13

1. Legal basis
The legal basis of RASFF is found in Article 50 of
the Regulation (EC) No 178/2002. This provisionlays down the fundamental rules and the formalprocedures for RASFF, which foresees the notifica-tion of any direct or indirect risk to human healthderiving from food or feed (Article 50, Para. 1 ofRegulation (EC) No 178/2002). This system allowsinformation to be shared quickly between the Euro-pean Commission, the food and feed control author-ities of the Member States, EFSA and certain otherorganizations, in order to adopt coordinated safetymeasures efficiently and promptly.
2. Members
All EU Member States are part of the RASFF,together with the European Commission and theEFSA (Article 50, Para. 1 of Regulation (EC) No178/2002). Article 50, Para. 6 of Regulation (EC) No178/2002 foresees the possibility of the participationof applicant countries, third countries and interna-tional organizations in the RASFF, on the basis ofagreements between the Community and thosecountries or international organizations. Theseagreements provide reciprocity and include confi-dentiality measures equivalent to those applicable inthe Community. On the basis of those agreements,all the EFTA Member States Iceland, Liechtensteinand Norway are members of RASFF as well. Switzer-land, is not a member of the RASFF, although itshould be mentioned that the Swiss Health Author-ity “Schweizer Bundesamt für Gesundheit (BAG) ” is in
a continuous contact with the RASFF-Members.
All RASFF members have specific contact points.
For instance, in Germany, the Office of ConsumerProtection and Food Safety “ Bundesamt für Ver-
braucherschutz und Lebensmittelsicherheit (BVL) ”
has been designed as the competent contact point,while in Italy, the competent contact point is theMinistry of Health (“ Ministero del Lavoro, della
Salute e delle Politiche Sociali ”) and in Hungary, it is
the Hungarian Food Safety Office (“MagyarÉlelmiszer-Biztonsági Hivatal”)
17. These contact
points are responsible for exchanging informationon any direct or indirect risk to human health,deriving from food or feed (Article 50, Para. 1 ofRegulation (EC) No 178/2002); by notifying theCommission. The Commission (DG SANCO) has the task of man-
aging the network (Article 50, Para. 1 of Regulation(EC) No 178/2002 ). Hence, it receives all notifica-tions from members and carries out the necessarychecks before forwarding this information to theother members of the network (for instance regard-ing the completeness, the legislative requirements;the subject of the notification, the translation of theinformation into English, etc.).
Finally, also EFSA
18is involved in the RASFF:
this Authority receives all information forwardedvia this system (Article 35 of Regulation (EC) No178/2002). EFSA ’s task as an independent scientificbody is to analyze the content of these messages inorder to provide the Commission and the MemberStates with any information required for the pur-poses of risk analysis.
3. Information to be notified
According to Article 50, Para. 2 of Regulation (EC)No 178/2002, a RASFF notification is requiredwhen a RASFF member has any information abouta serious health risk deriving from food or feed; inthese cases, European Commission has to be noti-fied immediately through the RASFF. Article 50,Para 3 of Regulation (EC) No 178/2002 specifies thatRASFF members shall notify the Commission inparticular if they take such measures as withdraw-ing or recalling food or feed products from the mar-ket or when they restrict the marketing of the prod-uct in question. Moreover, members shall notify, ifthey agree with the responsible operator that a foodor feed should not be placed on the market if themeasure is taken on account of a serious risk. Exam-ples of health risks which may induce a notificationare, for instance salmonella in meat, parasites (lar-30 Years of the Rapid Alert System for Food and Feed 14
17 See for more detailed information on the single contact points:
http://ec.europa.eu/food/food/rapidalert/members_en.htm.
18 With regards to EFSA see: S. Gabbi, L’autorià europea per la
sicurezza alimentare, Giuffrè, Milano, 2009; V. Silano, Science,Risk Assessment and Decision-Making to Ensure Food and FeedSafety in the European Union, EFFL, 2009, p. 400; A. Kocharov,Data Ownership and Access Rights in the European Food SafetyAuthority, EFFL, 2009, p.335; B. van der Meulen, Science basedFood Law, EFFL 2009, p. 58; A. Alemanno/S. Mahieu, The Euro-pean Food Safety Authority before European Courts, EFFL, 2008p. 320; J. Savigny/L. Lizardo, Risk Communication to the Public-Responsibilities to Stakeholders, EFFL, 2008, p. 376; S. Gabbi,The Interaction between Risk Assessors and Risk Managers, EFFL,2007, p. 126.EFFL 1|2010EffL 1-10 11.02.2010 13:24 Uhr Seite 14

30 Years of the Rapid Alert System for Food and Feed
vae, worm, insects) in fish, fruits, dried fruits and
nuts, mercury in fish (tuna, swordfish, shark), afla-toxins in nuts, listeria in fish & cheese, pesticides infruits and vegetables, dioxins in cod liver oil & vet-erinary drug residues and migration of PrimaryAromatic Amines (PAA), phthalates and heavy met-als from plastic articles which come into contactwith foods.
It is the competent authority of the contact
points that decide if a specific issue falls under oneof the above mentioned cases. When notification isnecessary, a specific RASFF notification form isused; in order to provide the information to theCommission; which include details of the findingsand measures taken and all relevant documentssuch as bills, lists of companies having received theproducts, analytical reports, etc. After assessing theinformation (see above), the Commission forwardsthe alert to all RASFF members using one of the fol-lowing four types of notification.
4. Different types of RASFF notifications
It is important to emphasize that four types ofRASFF notifications exist: border rejection andmarket notification; the latter are subdivided intofurther two categories: alert and information notifi-cations.
A border rejection (see below Fig. 2) is sent when
a product’s entry is refused into the Community. Onthe other hand, a market notification is sent when arisk is found in a food or feed product placed on themarket. As mentioned above, there are two types ofmarket notifications: alert and information notifica-tions. Alert notifications (see below Fig. 3) are sentwhen a food or feed presenting a serious health riskis on the market and when rapid action is required.The scope of this notification is to provide allRASFF members with the information in order toconfirm whether the product in question is on theirmarket or not, so that they can also take the neces-sary measures. Information notifications (see belowFig. 4) shall be used when a risk is identified aboutfood or feed placed on the market, but the othermembers do not have to take rapid action. This isbecause the product has not reached their market orit is no longer present on their market or becausethe nature of the risk does not require rapid action.Finally, there are the news notifications (see belowFig. 5) which comprise any information related tothe safety of food and feed not communicated as an
alert or an information notification, but which isconsidered to be “interesting” or important for thecontrol authorities.
Source: http://ec.europa.eu/food/food/rapidalert/rasff_notifications_en.htm
5. Information provided to non-member
countries
The RASFF procedures foresee mechanisms in
order to have non-member countries included. Firstof all, in order to avoid the recurrence of the prob-lem detected, Article 53, Para 4 of Regulation (EC)No 178/2002 provides that if a product, subject to anotification, originates from a country that is not amember of RASFF (this is very often the case, forinstance in the melamine crisis), the Commissionnevertheless shall forward the notification informa-tion for further actions such as delisting of estab-lishments, suspension of exports, intensification ofcontrols and change of the legislation. The notifica-tion of non-members is done in a systematic wayvia the Commission Delegations and, in cases ofserious food or feed safety problems, sending a let-ter by the Commission directly to the competentauthority of the country concerned. In additionwhen the corrective plans and guarantees receivedfrom third countries are not sufficient, the Commis-sion may take more restrictive measures; forinstance prohibition of imports, systematic controlat the EU borders, mandatory presentation of healthcertificates, etc. The same notification duty isEFFL 1|2010 15
Fig. 2 Fig. 3
Fig. 5 Fig. 4EffL 1-10 11.02.2010 13:24 Uhr Seite 15

incumbent upon the Commission when a food or
feed subject to a notification is exported to a coun-try which is not a member of the RASFF. The scopeis to enable the non-member country (third coun-try) to undertake the necessary safety measures.
6. Publication of RASSF
All RASFF information is published on the onlinesearchable database “ Rapid Alert System for Food
and Feed (RASFF) Portal website ” (https://webgate.
ec.europa.eu/rasff-window/portal/) which was setup in July 2009 and which replaces the weekly sum-mary of notifications published on this web site. Inthis regard, attention should be paid to the fact thatconfidentiality requirements for the RASFF exist(see Article 52 of Regulation (EC) No 178/2002).Information in the RASFF shall in general be avail-able to the public, but members of the network arenot allowed to disclose any information which byits nature is covered by professional secrecy.
7. Implementation measures
Article 51 gives the Commission the power to adoptmeasures implementing Article 50. A CommissionRegulation is being drafted together with moredetailed guidelines with implementing measuresfor the RASFF. The scope is to set up a harmonizedapproach.
IV . Outlook: The global vision
A lot of food crises are global (for instance, themelamine crisis, described below under point V .,was a global one). The importance of the visiondescribed by Jan Baele, Policy Officer RASFF, Euro-pean Commission (2002–present) with the words“Whether it is in the context of INFOSAN or through
regional training sessions, the future of RASFF isinternational. ”
19becomes clear. Indeed, this aim is
in its phase of realization; through the EU, RASFF iscollaborating with third countries as well as withregional networks, with the World Health Organiza-tion (WHO) alert system and with the InternationalFood Safety Authorities Network (INFOSAN). TheWHO set up an integrated Alert System for epi-demics and other public health emergencies, called“Global Alert and Response ” (GAR) which is based
on strong national public health systems and capac-ity and an effective international system for coordi-nated response
20. Moreover, considering that, due
to the globalization of food production and trade,there is a risk of international cases concerningfood safety, the WHO, in collaboration with theFood and Agriculture Organization of the UnitedNations (FAO), has developed and manages the“International Food Safety Authorities Network ”
(INFOSAN) which is a global network of 177national food safety authorities
21. As we will see22,
INFOSAN took the lead role in the melamine case,by gathering information from amongst othersChina, the US Food and Drug Administration andfrom RASFF, in order to send the most accurate andup-to-date information to all INFOSAN membersacross the globe. This system, which disseminatesinformation about food safety issues and whichtends to improve national and international collabo-ration, was launched in 2004. INFOSAN consists ofnational focal points in the member countries thatreceive information from the WHO, in the form ofINFOSAN notes about relevant food safety issues(from food safety implications of a disease outbreakto food allergies) and distribute it to all relevantministries in the member countries. In addition,national contact points shall inform INFOSANwhen there is an emergency situation regardingfood contamination and food-borne disease withinternational implications.
V . Case study
After having explained the history and the func-tioning of RASFF, and its cooperation with otherAlert Networks worldwide, let’s come to a specificrecent example of its application, which is themelamine case. Melamine is a chemical compoundcommonly used in the manufacture of resins, plas-tics, glues and artificial fertilizers. Melamine isapproved for use as a food contact material but itsdeliberate addition to food is not allowed. Themelamine is a six nitrogen atoms containing30 Years of the Rapid Alert System for Food and Feed 16
19 See p. 37. of the RASFF Booklet, cited above in footnote 3.
20 See more about the WHO Website: http://www.who.int/csr/en/.21 See more about INFOSAN on the WHO Website:
http://www.who.int/foodsafety/fs_management/infosan/en/.
22 See below point V.EFFL 1|2010EffL 1-10 11.02.2010 13:24 Uhr Seite 16

30 Years of the Rapid Alert System for Food and Feed
(C3H6N6) heterocyclic compound (1,3,5- triazine-
2,4,6,-triamin), which due to its high nitrogen con-tent is appropriate to be used in food adulteration(see the chemical structure of the melamine pre-sented in Fig. 6.)
Fig. 6: The chemical structure of the melamine
The adulteration can be relatively simply detectedin case of the dilution of the valuable proteins con-taining milk even in less equipped laboratories.Consequently, the adulterators try to ensure thenitrogen level, according to the expectable nitrogencontent of proteins, adding other compounds to themilk. The traditional methods (such as the Kjeldahlmethod) and in routine laboratories for the detec-tion of proteins will obviously show a relativelyhigh nitrogen content. The experts carrying outsuch an examination thus may conclude that theexamined milk has the expected protein level. Obvi-ously, using more sophisticated and more expensivelaboratory methods (such as IR or UV spectroscopy,amino acid analysis) the melamine can be detected,however, these are not part of the so-called routinetests.
The first news about infant infections in China
(especially kidney problems: nephrolithiasis, tissuedamage, acute renal insufficiency) appeared in theEuropean media on 8
thSeptember 2008. The con-
nection between kidney damage and the high levelmelamine contamination of the milk powder con-sumed by infants was revealed very quickly. On 12
th
September 2008, the Chinese authorities ordered anation-wide examination of milk and milk powderproduced for infants, which caused the death of an
infant due to kidney stone formation. Similar ill-nesses had been reported continuously in the north-western region of the country since the end of June2008. Consumer concerns and the attention of theauthorities were also intensified because of thenews in the international media about the steadilyincreasing number of ill Chinese infants (over fiftythousands) and some death cases, and also becauseof the fact that a large quantity of Chinese productsbased on milk and milk powder is imported into theEuropean Union. The possibility of using contami-nated milk powder was a danger in the case of theimported products, first of all in composite foods(products containing components both of animaland plant origin), such as chocolates, biscuits andcream filled waffles. The producer of the melaminecontaminated milk powder, the largest milk productproducer of the country (Sanlu Group) had with-drawn seven hundred tons of milk powder pro-duced before 6
thAugust.
Melamine contaminated Chinese infant milk
powder, which caused the illnesses of 432 childrenwas reported to the above described Alert System,the RASFF, on 15
th September 2008. According to
the communication of the INFOSAN System of theWHO
23on 16th September 2008, the consumption
of milk powder contaminated by melamine hadcaused illnesses (first of all kidney problems) of1253 infants less than 11 months old. According tothe RASFF communication on 17
thSeptember
2008, the number of ill infants had reached 6244and three of them died due to the consumption ofmelamine contaminated milk powder. The Chineseauthorities had examined the melamine content ofthe products of 109 producers of the 175 infantfood producers until that time and based on thisexamination 22 products of 69 producers were con-taminated. The measured melamine contaminationvaried between 0.09-619 mg/kg, but in case of theSanlu products 2563 mg/kg melamine contamina-tion was detected. All the contaminated products ofthe 22 producers were withdrawn from the market.Furthermore, the yoghurt ice cream exported toHong Kong and the tinned coffee drinks producedin Taiwan (China) were withdrawn, too.
On 17
thSeptember 2008, the European Commis-
sion has asked EFSA24to provide urgent scientific
advice based on risk assessment regarding the con-sumption of melamine contaminated foods inEurope; and to evaluate the probability of worst
23 See more information on this system above, part IV.EFFL 1|2010 17
EffL 1-10 11.02.2010 13:24 Uhr Seite 17

case scenarios (this means the consequences of the
highest consumption of the most contaminatedproducts). EFSA informed the European Commis-sion about the results of this risk assessment on 24
th
September 200825. EFSA developed a number of
theoretical exposure scenarios for biscuits andchocolate containing milk powder, both for adultsand children. On the basis of these scenarios, EFSAconcluded that the estimated exposure did not raiseconcerns for the health of adults in Europe; but thatchildren, in worst case scenarios, consuming thehighest level of contamination, would exceed theTolerated Daily Intake (TDI). Based on this scientificopinion, on 26
thSeptember 2008, the European
Commission adopted, as an interim measure, Deci-sion No 2008/757/EC, imposing special conditionsgoverning the import of products containing milkor milk products originating in or consigned fromChina
26. The European Commission regarded the
measures involved in the Decision as “ precaution-
ary”, because at that time melamine contaminated
food had not been yet found amongst the productson the market in Europe. The EU Standing Commit-tee on Food Chain and Animal Health (SCFCAH) inits meeting held on 10
thOctober 2008 made some
amendments, based on which the European Com-mission adopted the Decision No 2008/798/EC on14
thOctober 200827. The chronological progress of
events is presented in Table 1.
The European decision makers were not sur-
prised by the Chinese reports about the melaminecontaminated foods, because following reports ofsickness and death of pet animals (cats and dogs) inthe United States, an investigation was undertakenby the US authorities to trace the source of theseanimal health problems. The American Food andDrug Administration (FDA) had forbidden the plac-ing on the market of all feed products containingmelamine contaminated wheat gluten or rice pro-tein concentration originating from China. Follow-ing this, EFSA published its preliminary scientificopinion about the occurrence of melamine andstructurally similar, analogous compounds in foodsand feeds
28. Consequently, the data regarding the
contaminated foods and the level of contaminationwere already available, based on which EFSA pre-pared its risk assessment following the serial ill-nesses in China in 2008. According to that, in thecase of consumption of chocolate, biscuits, caramelsand other foods containing contaminated milk pow-der, the melamine intake would not exceed the Tol-erable Daily Intake (TDI) of 0.5 mg/kg body weight
per day even in worst case scenarios.
Based on the available data, the consumers would
have to intake a very large quantity of contaminatedFebruary 2007 Death of pet animals due to con-
taminated feeds in the USA
8thJune 2007 EFSA preliminary opinion regard-ing melamine contamination infoods and feeds
8th September 2008 Reporting of infant kidney dis-eases in China
12th September 2008 China orders a national examina-tion
15thSeptember 2008 EU RASFF report
17thSeptember 2008 EC mandate to EFSA regarding riskassessment
24thSeptember 2008 EFSA risk assessment sent to EC
25thSeptember 2008 EFSA publishes risk assessmentand press release
25thSeptember 2008 EC announces safety measures
26thSeptember 2008 EC adopts Decision (2008/757/EC)
1stOctober 2008 The Decision of the HungarianMinistry for Agriculture and RuralDevelopment regarding the appli-cation of the 2008/757/ECDecision
10thOctober 2008 SCFCAH meeting with participa-tion of Member States representa-tives
14thOctober 2008 EC adopts new Decision(2008/798/EK)30 Years of the Rapid Alert System for Food and Feed 18
24 With regards to EFSA’s role see above, part III.
25 See Statement of EFSA on risks for public health due to the pres-
ences of melamine in infant milk and other milk products inChina, adopted on 24 September 2008, Question number: EFSA-Q-2008-695.
26 OJ L 259, 27.9.2008, p. 10.27 Commission Decision No 2008/798/EC of 14 October 2008
imposing special conditions governing the import of productscontaining milk or milk products originating in or consigned fromChina, and repealing Commission Decision 2008/757/EC, OJ L273, 15.10.2008, p. 18.
28 EFSA provisional statement on a request form the European Com-
mission related to melamine and structurally related to com-pounds such as cyanuric acid in protein-rich ingredients used forfood and feed, 7 June 2007, Question number: EFSA-Q-2007-093.EFFL 1|2010
Table 1: Chronology of the melamine contamination EffL 1-10 11.02.2010 13:24 Uhr Seite 18

30 Years of the Rapid Alert System for Food and Feed
foods to be able to exceed the TDI. This means that
adults would have to eat between 30 to 50 kg of con-taminated biscuits (depending on the type of bis-cuit), or 4 kg contaminated chocolate per day. Chil-dren would have to eat between 10 to 17 kg of con-taminated biscuits or 1 kg contaminated chocolateper day to reach this level. Consequently, adults andchildren with a mean consumption of chocolate,cookies and milk toffee or other foods containingmilk powder – according to the EFSA calculations –will not reach the critical level of melamine intake.However, in worst case scenarios – based on thecontamination levels known at present – childrencould potentially exceed the TDI by more than threetimes consuming regularly significant quantity ofchocolates containing milk powder and/or cookieswith high level of contamination. It means that anaverage six years old child who is consuming morethan 42 grams of chocolate or more than 44 gramsof creamy filled cookies would exceed the TDI pro-vided the products were highly contaminated. Inthe case of a six year old child with about 20 kgbody weight consuming more than 42 grams con-taminated chocolates per day the melamine intakewere three times higher than the TDI.
That is why the European Commission adopted
with the first Decision 2008/757/EC on the 26
thSep-
tember 2008, a total ban on all products containingmilk originating from China for infants and youngchildren. They ordered laboratory analysis on allcomposite foods (containing both animal and plantorigin products) from China, including feeds,containing more than 15 % milk powder. It hadalso been decided to destroy all products with morethan 2.5 mg/kg melamine content. This Decisionis based on Article 53 of the Regulation (EC) No178/2002/EC, which makes it possible to adoptappropriate community emergency measures –regarding food or feed imported from a third coun-try – in order to protect human health, animalhealth or the environment provided the risk cannotbe effectively reduced by the measures of the indi-vidual Member States. The European Commission,by adoption the second Decision No 2008/798/ECon 14
thOctober 2008, further increased the severity
of its measures following the consultation with therepresentatives of the Member States (StandingCommittee on Food Chain and Animal Health,SCOFCAH) and ordered the testing of all milk con-taining products, because there is no informationeither about milk powder content or about thequantity of milk used for the product on the prod-
uct labels. Control points have also been designatedto the Member States where checks can be carriedout.
In the meanwhile, the food controlling authori-
ties of some Member States ordered the recall ofcertain melamine contaminated products. The EUMember States imported approximately 19.500tons of confectionery products and sweets amongothers biscuits, cookies and candies from China in2007. Furthermore, 1250 tons of chocolate andchocolate products were imported into the EU. TheItalian Authorities decided to carry out extraordi-nary checks regarding the Chinese import foodproducts and demanded proof in case of non milk-based products that the product was milk-free. Themarketing of milk products of Chinese origin wasbanned and the checks of all infant milk productsand milk based products were ordered in France.The Tesco supermarket chain recalled the Chinese‘White Rabbit Creamy Candies’ products during thesecond part of September 2008 because melaminecontaminated candies were found in Singapore andin New-Zealand. Having found melamine in can-dies, Singapore was among the first States to banthe placing on the market of all milk products ofChinese origin. Malaysia also banned the import ofChinese milk products. Japan and Hong-Kongrecalled the Chinese products from the shelves ofthe supermarkets. Due to the assumed melaminecontamination, the British Cadbury confectioneryproducer withdrew 14 types of chocolate products,which were produced by its factory in Beijing.These products – chocolates, bars of chocolate andtoffees filled with chocolate cream – were recalledalso in Taiwan, Hong-Kong and Australia. All typesof Chinese milk products were forbidden on thePhilippine Islands at the end of September. Follow-ing the outbreak of the scandal, Australia withdrew4 products imported from China: the White RabbitCreamy Candies, one of the Cadbury chocolates pro-duced in China, the Lotte Koala cookie and the Kirinmilk tea. Besides this, the Australian authoritiespaid special attention to the vegetables importedfrom China, which due to their regular insecticidecontamination anyhow belong to the group of riskyproducts to be examined with increased intensity.
The widespread control of milk products was
ordered following the intoxication in China and thecontaminated products were withdrawn from themarket. According to the communication of theEFFL 1|2010 19EffL 1-10 11.02.2010 13:24 Uhr Seite 19

Chinese Food Safety Authority, melamine was
detected in more than 10 percent of the milk andyoghurt drink samples of three leader milk compa-nies. The selling of ‘White Rabbit Creamy Candies’produced from milk was banned on the 26
thSep-
tember 2008. The ‘White Rabbit Creamy Candy’ isone of the best known Chinese products worldwide.The production of this milky candy packaged intoedible rice paper was started in Shanghai in 1943.The contaminated candy was found in Singapore,but it was imported into 50 countries, too. The sell-ing of the Chinese ‘White Rabbit Creamy Candies’was banned in 50 countries, among others inCanada and in Great Britain. The internationalmedia (AFP) reported on 17
thOctober 2008 that the
selling of the ‘White Rabbit Creamy Candies’ withmelamine free label has been restarted in China.The scandal – involving milk, milk products, choco-lates, candies and other foods based on milk powder– did cause a crisis in the milk industry, the con-sumption dropped, the milk processing companiesrefused to buy the milk from the farmers.
The Hungarian Authorities published an official
call on 19
thof September 2008 in which the con-
sumers were reminded about the fact of adulter-ation and about the random checks of milk basedproducts present on the Hungarian market and offoods available in the Asian shops in Hungary. TheHungarian Ministry for Agriculture and RuralDevelopment (FVM) and the Hungarian FoodSafety Authority (MÉBiH) communicated the banof the use of privately obtained Chinese milk pow-der and infant food. Based on the decision of theHungarian chief veterinary officer (FVM) – in orderto implement the above mentioned CommissionDecision No 2008/757/EC – the import of all Chi-nese infant and children composite foods, fallingwithin the scope of Directive 2009/39/EC regardingfoodstuffs intended for particular nutritionaluses
29, was banned in Hungary on 1stOctober 2008.
In accordance with the decision of the EuropeanUnion risk managers the placing on the market ofthe Chinese foods and feeds with more than 15 %milk content were obliged to be controlled. All ven-tures dealing with foods and feeds were obliged tohave foods and feeds of Chinese origin (or trans-ported through China) tested and the melaminecontent determined if the products contained morethan 15 % milk or the milk content was unknown.The authorities checked the stocks placed on themarket eventually following the news about thecontamination of the ‘White Rabbit Creamy Can-
dies’ at the end of September 2008. The melaminewas detected, but the level of contamination wasunder the TDI. The flavoured peanuts produced inChina, in which the food safety experts detected amelamine level up to 8 times higher than the TDI,were delivered into 150 shops in Hajdú-Biharcounty in Hungary. Due to the suspicion ofmelamine contamination the marketing of 5.5 tonsof Nestlé coffee whitener imported from Bangkokwas suspended by the authority. It was the companyitself which initiated the control of the product, butthe results were very divergent. According to theresults of the official control, the average melaminecontamination in the products did not reach theTDI. Melamine contaminated eggs were found inHong Kong at the end of October 2008, when thescandal due to the melamine contaminated foodswith Chinese origin had just calmed down inEurope. According to certain reports, melaminecontaminated eggs had already been found at theend of September 2008 and those eggs weredestroyed in China. No melamine contaminationwas detected in the Chinese eggs during the tests atthe end of October 2008. The melamine penetratedinto the eggs probably due to the contaminatedfeeds. The Food and Agricultural Organisation(FAO) of the UN called upon China to disclosewhether the feeds were exposed to contamination.The UN experts were worried that besides the eggsthe meat of farm animals and even fish could alsobe contaminated. In December 2008 melamine con-taminated soy and soy products originated fromChina were found in some Member States.Melamine was also determined in ammoniumbicarbonate, which was used by the food industry asa raising agent.
Altogether 294.000 cases were registered offi-
cially and among sick people approximately 53 000people were hospitalised and six infants died. InJanuary 2009, Chinese Courts sentenced two men todeath for endangering public safety in a tainted-milk scandal that killed at least six children, accord-ing to state-run news agencies. Three other defen-dants, including a top dairy company executive,were sentenced to life imprisonment. Another30 Years of the Rapid Alert System for Food and Feed 20
29 Directive 2009/39/EC of the European Parliament and of the
Council of 6 May 2009 on foodstuffs intended for particularnutritional uses, OJ L 124, 20.5.2009, p. 21; which has repealedthe former Council Directive 89/398/EEC of 3 May 1989.EFFL 1|2010EffL 1-10 11.02.2010 13:24 Uhr Seite 20

30 Years of the Rapid Alert System for Food and Feed
defendant received a suspended death sentence,
and 15 others were given prison terms from 2 to 15years.
VI. Conclusion and outlook
What conclusions may we draw from the melaminecase? First of all, RASFF has clearly proved itself tobe an effective tool for monitoring food safety inEurope. However, the melamine scandal has alsoshown that in the age of globalization, foods pro-duced anywhere in the world can be placed on themarket in any other continent or region of theworld without sufficient knowledge regarding thecircumstances of the production and/or the appliedmethods. The RASFF provides timely and usefulinformation for the Member States’ authorities,alarming them in the case of the circulation of con-taminated foods. On the other hand, not every con-taminated item may be detected by the RASFF,especially if some of the presently used methods areunable to detect relatively simple adulterationcases. In this regard, it shall be reviewed whetherthe application of the “Kjeldahl”-method for thedeterminations of the proteins is still appropriatetoday, taken that it is a method, which providesfalse results if the detected nitrogen is in accor-dance with the expectable protein level. This entailsmany further questions: Is there any possibility tointroduce and to use widespread, more modern,more reliable methods regularly? Do we have thenecessary infrastructure? Would it be possible tofinance these new methods and their application?Would the less developed countries be able tofinance these tests? Who would finance theexpenses of the producers if the EU Member Statesintroduced the regular and widespread applicationof these methods? Who would be obliged to pay?Would it be the producer, the distributor or the con-sumer? How much higher would the prices be if weintended to apply the stricter demands and themore reliable but more expensive methods? Does
the product traceability work in the everyday prac-tice? Is it possible to recall immediately and fullythe contaminated food products delivered to allparts of the world, to determine the origin of con-tamination and to abolish the contaminationsources at the same time? If the traceability hadworked correctly in the global food chain, the find-ing of contaminated eggs would not have occurred,weeks after the mass illnesses due to contaminatedmilk and raise the possibility of the existence ofcontaminated meat.
As far as the functioning of the food safety sys-
tems concerned, the melamine scandal has alsorevealed that there are great differences regardingthe regions, the consistency of the authorities, theirstrictness, the transparency of their work and meas-ures, as well as the power of the media and public-ity. The scandal and the series of mass illnessescaused by the melamine contaminated milk andmilk powder present a good example how far-reach-ing and how difficult is to review and control thefood chain, in other words the food net. Hence, it ismost important to continue the establishment of anefficient Alert Systems on a global scale. RASFF hasapproached the WHO about working together withINFOSAN, to create a strong global system toensure food safety and thus to protect people acrossthe globe. This involves as well adequate training.Having acknowledged this importance, the Euro-pean Commission has launched the training initia-tive of “ Better training for Safer Food Programme of
the European ”
30covering food and feed law, animal
health and welfare and plant health rules. It trainsstaff involved in official controls of the MemberStates, of candidate countries and also of thirdcountries, in particular of developing countries.Under the framework of this training strategy, thesecountries are assisted in developing their ownregional alert systems based on the RASFF model.This will allow regional groups to cooperate betterwith INFOSAN and RASFF when global crisesoccur; and contribute to a higher level of protectionof their own people. Thus, the global vision of foodsafety exists and needs now to be realized step bystep.
30 Learn more about this initiative on the Website European Com-
mission Website: http://ec.europa.eu/food/training_strategy/index_en.htm.EFFL 1|2010 21EffL 1-10 11.02.2010 13:24 Uhr Seite 21

Copyright of European Food & Feed Law Review is the property of Lexxion Verlagsgesellschaft mbH and its
content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's
express written permission. However, users may print, download, or email articles for individual use.