European Feed Additives and PreMixtures Quality System

Annual Report 2007

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2007 Overview ...................................................................................................................................................... 4

Members and statistics ................................................................................................................................ 6

Activity review ......................................................................................................................................................... 8

FAMI-QS structure ......................................................................................................................................... 10

Annual report of the experts group ...............................................................................................12

Contents

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2007 Overview

“2007/C 64/04” - This is the unimpressivereference in the Official Journal of theEuropean Union stating that the StandingCommittee on the Food Chain and AnimalHealth assessed and approved FAMI-QS pursuant Regulation (EC) No 183/2005.

“Community guide to good practice for feedadditives and premixtures operators” - This is the impressive associated title ofFAMI-QS, strengthening the standard withconsiderable added value for our current andfuture members as it is the formal link withthe European Feed Hygiene Regulation.

We are proud that we could pass on thisclear signal early in 2007 to the feed indus-try. It confirms that FAMI-QS is on the rightpath, it reinforces our position and imposesthe obligation to maintain and further developFAMI-QS as the leading standard for feedadditives and premixtures.

The continuously increasing number of FAMI-QSmembers explicitly proves that it is more than avoluntary guide. Using the auditing by accreditedcertification bodies, it provides documented

assurance of compliance with European FeedRegulation and a competitive advantage throughsuperior processes. The statistical figures in thisAnnual Report show that this benefit is of soaring value for third country operators.Concerning the European operators, ourongoing discussions with the Feed ControlOfficials in the Member States seem to result inthe advantage of reduced control activities.

Having a lot of members that have appliedFAMI-QS for several years, we are glad tohear that it is more than an aid to complywith regulatory and feed safety needs. As the feed market requests suppliers thatare in a position to fulfil the industryrequirements on a long term, some opera-tors praise FAMI-QS as a tool to upgradethe company image and to provide continualimprovement. They also recognise a clearer view of internal procedures, areduced amount of complaints and claimsand a positive change in the attitude of theemployees.

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The FAMI-QS Board and Expert Team appreciate those comments andtake it as a challenge for keeping FAMI-QS practical as well as effective.To achieve this, we will further provide our members with the valuablebackup of FEFANA’s professional regulatory and industry experience. Let me take the opportunity to thank FEFANA for its outstanding supportand always open co-operation.

Feed additives and premixtures are characterised by special products,processes and procedures requiring specialised and dedicated peopleto take care of and use their product know-how in regulatory, qualityand safety initiatives to bring legislative, control and industry concernsin tune. Hence FAMI-QS feels sufficiently strong to take over theQuality Assurance stewardship for the feed additive and premixturepart of the feed to food chain and is prepared to share this asset withall its members.

Although a European non-profit association, FAMI-QS does not limit itsactivities to European stakeholders. It is one of our visions in a globalfeed-to-food chain to ensure safety of feed additives and premixturesproduced and consumed inside EU as well as those exported to or

imported from third countries. Again, this is part of the Feed HygieneRegulation, part of our unexpressed promise to the European Commissionand part of the liability we feel as a holder of a Community Guide and as anadvisor of our members.

Encouraged by the achievements of 2007, we will continue in 2008 andbeyond to - keep close contact with European Member States and chain partners

to evaluate any co-operation to ease the burden of control for FAMI-QSmembers

- keep close contact with the EU Commission and third countryAuthorities to ensure the safety of imported material, while also ensuringfreedom of trade

- further evolve FAMI-QS Guides and Codes to map regulatory and indus-try developments and facilitate their implementation.

Dr. Dieter Greissinger Dr. Didier JansPresident Secretary General

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Note: These figures have been updated on January 17, 2008.

Figure 1: This figure represents the evolution of the number of feedadditives and premixtures operators which have succesfully completedthe process of certification since the first FAMI-QS certificate has beenawarded, in November 2004.

Beside the unconditional support from the European industry to ourquality and safety system, it can be seen that 3rd country operatorshave been increasingly joining FAMI-QS certification as its added valuefor exporters who want to meet EU legislative requirements has beenshown.

Figure 2: This figure shows the amount of certified operators togetherwith those in the process of certification. Companies “in process” willpresumably be certified during 2008 (both in EU and non EU countries).Nearly 400 companies are either “in process” or certified. Their namescan be consulted through the website: www.fami-qs.org

Both figure 1 and 2 show the striking evolution of FAMI-QS, reaching aglobal dimension as its membership includes companies operatingworldwide.

Figures 3 and 4 (next page): show the implementation of FAMI-QS, inpercentage of distribution, per country.

Members and Statistics

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Activity Review

Stakeholders and chain partners meetings FAMI-QS has reached adequate recognition inthe feed sector and thus maintains regular con-tacts with the relevant stakeholders and chainpartners in the EU, building common policiesand technical developments as well as workingside by side with them. This includes other EUcode owners such as AIC (UK), OVOCOM(Belgium) and PDV (Netherlands), with whichFAMI-QS signed bilateral agreements in 2006.These agreements seal the mutual recognitionbetween the schemes. During 2007, the fourorganizations have consolidated the program ofmeetings that guarantees the proper coordina-tion of their systems.Due to the rapid globalization of FAMI-QS and itsimpressive implementation in non EU countries,FAMI-QS has also developed a 3rd countriesstrategy which aims regular contact with feedorganizations such as AFIA (USA), Sindiracões(Brazil) or the Chinese Feed Association.

Cooperation with EU and NationalAuthoritiesFAMI-QS maintains a strong and efficient cooperative spirit with the European Commissionand Member States representatives. On the one hand, the FAMI-QS Guide was sub-mitted to the European Commission’s evaluation

and, after a period of intensive work and adap-tation to the authority’s recommendations,FAMI-QS obtained the official recognition as aCommunity Guide to Good Practice for feedadditive and premixtures operators, asdescribed in Articles 20 and 22 of the FeedHygiene Regulation (EC/183/2005). This waspublished in the Official Journal (Serie C 64/17)on 20 March 2007.FAMI-QS is very satisfied with such a success confirming our approach to theimplementation of the EU legislation. The outstanding development of the FAMI-QS system and the increasing trust it isgaining towards national control authoritiesconfirms that the complementarity betweenFAMI-QS certification and official control can come up to real expectations.

International activityFAMI-QS has become such a prestigious stan-dard for the assurance of safety and quality offeed additives, that it has become a standard ofreference not only in the EU, but also at globallevel.

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Organizations such as FDA and FAO, among others, have requested the technical input ofFAMI-QS for the development of their respectivesafety standards.

Seminars and ConferencesWith the aim of promoting its objectives and staying in close relationship with the associatemembers, FAMI-QS organizes seminars, conferences and a series of public lectures on aregular basis. Thus, FAMI-QS recognizes the needfor the membership to have an appropriate forumto discuss and raise issues.Furthermore, during the year 2007, the associa-tion has developed several external promotionalactions by attending and actively participating invarious events for feed business operators.

Training session in ChinaFAMI-QS is aware that Europe is more and morewatched by supply and regulatory operatorsouside the EU, who are increasingly implementingthe high standards developed in Europe throughFAMI-QS. FAMI-QS is striving to accept this chal-lenge and integrate this global dimension into itsactivities to contribute constructively to the protec-tion of consumers. Because of the big impact thatFAMI-QS is having in China, and after the successof the first training session in Beijing (July 2006), asecond traineeship for auditors was organizedthere on 16 and 17 October 2007. Participantswere taught on EU legislation, the FAMI-QS Codeof Practice and its implementation. At the end ofthe two-day session, the auditors were invited to

go through an examination in order to evaluatetheir level of understanding on the subjects. Theresults were more than satisfactory, and the audi-tors showed to be well prepared for providingFAMI-QS audit and certification to the Chinesefeed additives and premixtures industry.

Communication plan and websiteFAMI-QS has established an effective communica-tion plan to ensure that all members, certificationbodies, stakeholders, authorities and other interestedparties can be aware of the association develop-ments as well as the technical progress in the rele-vant documents such as the Code and certificationrules. This is done through newsletters and pressreleases.Reinforcing this plan, the FAMI-QS website con-tains all the information that could be required.

Thus, our permanent staff can be easily reachedthrough the contact details provided on the web-site, assuring that all consultations and enquiriesare solved in a diligent and professional way.

EFIPFAMI-QS has been an active member of EFIP(European Feed Ingredients Platform) since itsfoundation. EFIP is conformed by all of the majorEuropean associations or federations representingthe sectors that supply Feed Ingredients to the EUmarket, and is a voluntary platform set to developbenchmark tools, evaluate sectors’ guides, shareexpe riences, cooperate and offer concerted guidance to all of their members on the implementation of the Feed Hygiene Regulationand relating safety schemes. Together, the EFIPmembers represent the vast majority of all “ingredients” that enter the food chain via compound feed (cereals, processed vegetablesor animal products, additives, and co-productsfrom the food processing industry).

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FAMI-QS Structure

FEFANA Asbl (EU Association of FeedAdditives and Premixtures Operators) pro-moted and developed the FAMI-QS Code ofPractice in 2003. With the aim of runningand managing this Code, the FEFANA Asblcreated a brotherhood association in May2004, the FAMI-QS Asbl (Feed Additive andPremixture Quality System EuropeanAssociation). Since then, FAMI-QS Asbl has been com-posed by Full Members and AssociateMembers:

• Full Members are manufacturers ortraders of feed additives or premix-tures, and are also members ofFEFANA. They are the permanentmembers of the General Assembly

• Associate Members are involved in thebusiness of feed additives or premixtures,and have obtained from one of theapproved certification bodies a certifica-tion that fulfils the criteria of the FAMI-QScode.

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The association is represented in any act by a Board ofDirectors, created for the administration and manage-ment of FAMI-QS. The Board of Directors is driving thepolitical and operational strategy of the association. The day-to-day management is delegated to theSecretary General who, together with the permanentstaff, is responsible of the smooth running of theAssociation. The FAMI-QS permanent staff is head -quartered in Brussels.

FAMI-QS receives technical support from the ExpertsGroup. The purpose of this group, composed by a teamof highly qualified experts in the quality field, is toembody the objectives and main working lines previ-ously defined by the Board of Directors.

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Report of the Experts Group

FAMI-QS received support from the ExpertsGroup whose members participated in severaltechnical meetings, like Expert Group meetingsand Certification Body meetings, held in 2007.

FAMI-QS recognized as CommunityGuideWith the changes of last year, mainly performeddue to recommendations from the EuropeanCommission and stakeholders in versions 4 ofthe Code of Practice and the Guidance docu-ments, FAMI-QS has been recognized by theStanding Committee on the Food Chain andAnimal Health as a Community guide to goodpractice to implement the requirements of theFeed Hygiene Regulation. The „Communityguide to good practice for feed additive and pre-mixture operators“ was finally published in theOfficial Journal (Serie C 64/17) on 20 March2007 and can be consulted on the EU website.Translations of the Guide to good practice areavailable in Dutch, French, German, Italianand Spanish on the FAMI-QS website.

Certification Process DescriptionThe Process Description changed to version4 in April 2007. The reviewed document waspresented and discussed at the CertificationBodies meeting in May 2007. The most

important changes of the new versioninclude:

- Enlarged requirements for Certification Bodiesand auditors like accreditation according to EN45011, qualification, experience an g that arelisted in a new chapter 4

- A formalized audit report template in annex 6- Specific requirements for certificates in

case feed additives are not yet classified intoa category or functional group in the EU-Register

- Requirements on certificates in case thecompany name and address changes

- An updated flow chart describing the flowof information during the certificationprocess

- A new chapter 12 describing the mutualrecognition between FAMI-QS and theschemes of AIC (UK), PDV (NL) and Ovocom (B)

- A new chapter 7.2 describing the gate-keeper principle.

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The Gatekeeper PrincipleThe condition for granting a FAMI-QS certifi-cate is that feed additive and premixture sup-pliers of a certified operator are themselvesFAMI-QS certified. This principle must berespected by all certified operators, never-theless FAMI-QS has recently added to it anexceptional and transitional alternative tosource feed additives and premixtures fromnon-FAMI-QS certified suppliers: the gate-keeper principle. It can be applied underdefined circumstances and for a limited volume of products and suppliers, afterrequest and approval from FAMI-QS. The company applying for the exception hasto be FAMI-QS certified, must audit and con-trol the supplier under the rules of FAMI-QSand can only source a part of its raw materialunder the certificate of exemption. This willensure that the products from the originalmanufacturer are meeting the full FAMI-QSrequirements described in the Code.The gatekeeper principle is exceptional, ten-tative and will be reviewed and adopted everyyear according to the regulatory progressand the progress FAMI-QS and FEFANAachieve in Europe and third countries.Provided a strict execution of the establishedrules, FAMI-QS is already now the most rigorous and demanding quality system withrespect to sourcing from third parties and theAsbl will perform a sound monitoring of the

implementation until regulatory and marketenvironment allow for a different procedure.

Certification BodiesThe pillars of the FAMI-QS certificationsystem are auto-control as well as controland supervision from a third independentparty: the certification body. By receiving a copy of the summary auditreport, FAMI-QS carries out the general monitoring of the work done by the certification bodies at the operator’s level.FAMI-QS maintains the confidentiality ofthese reports.

With the aim to guarantee an optimum level ofknowledge of its auditors and maintain thequality and excellence of the system, FAMI-QSprovided two full-day technical training ses-sions to its Certification Bodies in Brusselsduring the year 2007. The program and con-tents of these sessions are carefully conceivedand developed by the Experts Group togetherwith the FAMI-QS Quality Manager, whichactively participate in the training program. In addition to this, the certification bodies haveshown during this year a big progress in covering FAMI-QS under the scope of their EN45011 accreditation.

Jutta Hörr

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C o n t a c t i n f o r m a t i o n120, Avenue Lou ise (5th f loor B)1050 Brusse ls - Be lg iumPhone : +32 (0 )2 639.66.66Fax : +32 (0 )2 640.41.11E-mai l : in fo@fami-qs.orgWeb : www.fami-qs.org