COMMISSION DECISION
of 10 June 2008
imposing special conditions governing the import of sunflower oil originating in or consigned from
Ukraine due to contamination risks by mineral oil
(notified under document number C(2008) 2709)
(Text with EEA relevance)
(2008/433/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Community,
Having regard to Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January 2002 laying downthe general principles and requirements of food law, establishingthe European Food Safety Authority and laying downprocedures in matters of food safety (
1), and in particular
Article 53(2), second subparagraph, thereof,
Whereas:
(1) The Rapid Alert System for Food and Feed (RASFF) has
been notified on 23 April 2008 that sunflower oil orig-
inating from Ukraine was found contaminated with highlevels of mineral oil. This contamination by mineral oilwas later confirmed in several consignments of crudesunflower oil originating from Ukraine imported inrecent months in the Community. Sunflower oilcontaining high levels of mineral oil is unfit for humanconsumption and therefore deemed to be unsafe. Thesource of contamination is not yet known.
(2) The European Commission has repeatedly urged theUkrainian authorities to provide information on theorigin of the contamination and on the measures takento prevent it in future. Assurances were also sought fromthe Ukrainian authorities as to the establishment of
effective measures aimed at guaranteeing the appropriate
sampling and analysis on the presence of mineral oil inconsignments of sunflower oil leaving Ukraine withdestination the European Community.
(3) Investigations aimed at identifying the source of contam-ination are ongoing in Ukraine. The Ukrainian authoritiesalso committed to the establishment of an appropriatecontrol system that will ensure that all consignments ofsunflower oil to be exported to the European Union arecertified as not containing levels of mineral oil makingthe sunflower oil unfit for human consumption.However, the details of this control system have still to
be provided to the Commission. The Commission shouldassess the control and certification system in order toverify the accuracy and the reliability to guarantee thatthe sunflower oil exported to the Community does notcontain levels of mineral oil, making the sunflower oil
unfit for human consumption. It has to be ensured that
no exports of sunflower oil to the Community will takeplace until such control and certification system is put inplace and assessed and accepted by the Commission. Theassessment of the control and certification system will beperformed on the basis of detailed information providedby the Ukrainian authorities.
(4) After a request from the European Commission for anassessment of the risks related to the contamination ofsunflower oil with mineral oil, the European Food SafetyAuthority (EFSA) published a statement on the contam-ination of sunflower oil with mineral oil exported fromUkraine. The statement refers to assessments performedby the joint FAO/WHO Expert Committee on FoodAdditives (JECFA) indicating the different level oftoxicity depending of the type of mineral oil. EFSAconcluded that the available analytical data for thecontaminated sunflower oil from Ukraine indicated that
the mineral oil present was of high viscosity. Based upon
exposure estimates, EFSA concluded that the exposure ofsunflower oil contaminated with high viscosity mineraloil, although being undesirable for human consumption,would not be of public health concern in this case. Giventhat the source of contamination has not yet been iden-tified with certainty, there is the presumption of riskattached to the presence of unacceptable high levels ofmineral oil in sunflower oil.
(5) Given the level of risk, even once the control and certi-fication system will be accepted by the Commission,Member States should control the consignments ofsunflower oil in order to verify that such consignmentscontain a level of mineral oil conform to what it isdeclared in the certificate. This system of doublecontrol is necessary and justified in order to provideadditional guarantees for the accuracy and reliability of
the control and certification system put in place by the
Ukrainian authorities. The costs incurred for carrying outthese controls are to be borne by the operatorsresponsible for the import. Member States shouldinform the Commission of unfavourable results throughthe Rapid Alert System for Food and Feed. Favourableresults shall be reported to the Commission on a three-monthly basis. This obligation of information isnecessary for the measures to be reassessed.EN 11.6.2008 Official Journal of the European Union L 151/55
(1) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission
Regulation (EC) No 202/2008 (OJ L 60, 5.3.2008, p. 17).(6) Article 53 of Regulation (EC) No 178/2002 provides for
the possibility to adopt appropriate Communityemergency measures for food and feed imported froma third country in order to protect human health,animal health or the environment, where the riskcannot be contained satisfactorily by means ofmeasures taken by the Member States individually.
(7) Pending the assessment and acceptance of the controland certification system to be put in place by theUkrainian authorities, no imports of sunflower oil orig-inating in or consigned from Ukraine should take placedue to the risk of contamination with mineral oil.
(8) Member States have been informed of the contaminationincident and have taken the appropriate measures towithdraw the contaminated sunflower oil and foodproducts containing contaminated sunflower oil alreadyplaced on the market, as recommended by the EuropeanCommission via the RASFF.
(9) Given the urgency, pending the meeting of the StandingCommittee on the Food Chain and Animal Health, andafter having informed the authorities of Ukraine, theCommission adopted Decision 2008/388/EC on23 May 2008 imposing special conditions governingthe import of sunflower oil originating in or consigned
from Ukraine due to contamination risks by mineral
oil (
1), in accordance with the procedure laid down in
Article 53(2), first subparagraph of Regulation (EC)No 178/2002.
(10) Those measures should be confirmed and amended as
regards the costs of the controls, performed by the
competent authorities of the Member States.
(11) It is therefore appropriate to repeal and replace Decision2008/388/EC.
(12) The measures provided for in this Decision are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,
HAS ADOPTED THIS DECISION:
Article 1
1. Member States shall prohibit the import of sunflower oil,
falling within CN codes 1512 11 91 or 1512 19 90 10, orig-inating in or consigned from Ukraine (hereafter referred to assunflower oil), unless the consignment of sunflower oil isaccompanied by a valid certificate, certifying the absence ofunacceptable levels of mineral oil and the results of samplingand analysis for the presence of mineral oil.2. The certificate provided for in paragraph 1 shall only be
valid for imports of consignments of sunflower oil into theCommunity if the sampling and analysis of the consignmentand the issuance of the certificate have taken place after theEuropean Commission has assessed and formally accepted thecontrol and certification system put in place by the Ukrainianauthorities.
3. Member States will be informed of the details of the
control and certification system put in place by the Ukrainianauthorities and of the formal acceptance of it by theCommission through the Standing Committee on the FoodChain and Animal Health.
4. Member States shall take the appropriate measures to
sample and analyse each consignment of sunflower oil originat-ing in or consigned from Ukraine, accompanied by a validcertificate, presented for import to ensure that the consignmentscontain a level of mineral oil conform to what it is declared inthe certificate.
They shall inform the Commission of unfavourable results
through the Rapid Alert System for Food and Feed. Favourableresults shall be reported to the Commission on a three-monthly
basis.
5. Member States shall take the necessary measures to ensure
that the sunflower oil originating in or consigned from Ukraine,not complying with the provisions of this Decision, is notplaced on the market for feed or food use.
6. Member States shall ensure that the costs incurred in the
implementation of points 4 and 5 are borne by the operatorsresponsible for the import.
Article 2
Decision 2008/388/EC is repealed.
Article 3
This Decision is addressed to the Member States.
Done at Brussels, 10 June 2008.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN L 151/56 Official Journal of the European Union 11.6.2008
(1) OJ L 136, 24.5.2008, p. 43.