COMMISSION DECISION
of 29 April 2008
imposing special conditions governing guar gum originating in or consigned from India due to
contamination risks of those products by pentachlorophenol and dioxins
(notified under document number C(2008) 1641)
(Text with EEA relevance)
(2008/352/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 (1)(b)(ii) thereof,
Whereas:
(1) High levels of pentachlorophenol and dioxins have been
found in certain batches of guar gum originating in orconsigned from India. Such contamination constitutes athreat to public health within the Community if nomeasures are taken to avoid the presence of pentachlor-ophenol (PCP) and dioxins in guar gum.
(2) In response to this finding of elevated levels of PCP anddioxins, the Commission carried out an urgent inspectionvisit to India from 5 to 11 October 2007. The objectivewas to gather information on the possible source of thecontamination and to assess the control measures put in
place by the Indian authorities to avoid the re-occurrence
of this contamination. The inspection team concludedthat there is to date insufficient evidence of the causeof the contamination incident, and the investigationcarried out by the Indian authorities has been inadequateto provide any conclusions. With availability of sodiumpentachlorophenolate and its use in the guar gumindustry, and with a largely self regulated industry,there are inadequate controls in place to ensure thatthis contamination does not occur again.
(3) Without prejudice to the control obligations of theMember States, the measures to be adopted further tothe likely imports of contaminated products should forma comprehensive and common approach allowing rapidand effective action to be taken and avoiding disparitiesbetween the treatment of the situation by the variousMember States. It is therefore appropriate to adopt
special measures at Community level.
(4) To prevent fraudulent practice with the aim of evadingfrom the application of special conditions provided for inthis Decision to protect animal and public health, it isimportant that compound foodstuffs and feedingstuffscontaining to a significant amount guar gum originating
in or consigned from India are also within the scope of
this Decision. A threshold of 10 % is established.
(5) The Community Reference Laboratory for Dioxins andPCBs in Feed and Food has carried out a study on thecorrelation between PCP and dioxins in contaminatedguar gum from India. From this study it can beconcluded that guar gum containing a level of PCPbelow the level of 0,01 mg/kg does not contain unac-ceptable levels of dioxins.
(6) The Vimta Laboratory in Hyderabad, which was visitedby the inspection team, is an accredited, well staffed andwell equipped laboratory. Analytical performance for PCPin this laboratory was found to be adequate. Theanalytical performance in the other visited laboratorieswas assessed to be inadequate.
(7) It is appropriate to require that all consignments of guargum or products containing guar gum at significantamounts originating in or consigned from India andimported into the Community intended for human oranimal consumption, should be accompanied by ananalytical report issued by a laboratory accredited
according EN ISO/IEC 17025 for the analysis of PCP in
food and feed or by a laboratory that is pursuing thenecessary accreditation procedures and which hasadequate quality control schemes in place and thisanalytical report is endorsed by the competentauthority from the country where the laboratory islocated.
(8) The measures provided for in this Decision are inaccordance with the opinion of the StandingCommittee on the Food Chain and Animal Health,EN L 117/42 Official Journal of the European Union 1.5.2008
(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).HAS ADOPTED THIS DECISION:
Article 1
Scope
This Decision shall apply to:
(a) guar gum, falling within CN code 1302 32 90, originating
in or consigned from India, and intended for animal orhuman consumption;
(b) compound feedingstuffs and foodstuffs containing at least
10 % guar gum originating in or consigned from India.
Article 2
Conditions for first placing on the market
1. Member States shall prohibit the first placing on the
market of the products referred to in Article 1 unless an
original analytical report, issued by a laboratory accreditedaccording EN ISO/IEC 17025 for the analysis of PCP in foodand feed or by a laboratory that is pursuing the necessaryaccreditation procedures and which has adequate qualitycontrol schemes in place (
1) accompanying the consignment
demonstrates that the product does not contain more than0,01 mg/kg pentachlorophenol (PCP). The analytical resultmust be reported with the expanded measurement uncertainty.
2. The analytical report shall be endorsed by a representative
of the competent authority from the country where thelaboratory is located.
3. Before the physical arrival of consignments of products
referred to in Article 1, the feed or food business operatorresponsible for the consignment or his representative shallprovide prior notification to the competent authority of theMember State of arrival.
4. The competent authorities in the Member States shall
check that each consignment of the products referred to inArticle 1 presented for first placing on the market is accom-panied by an analytical report as provided for in paragraph 1.Each consignment of products referred to in Article 1, shall beidentified with a code which corresponds to the codementioned on the abovementioned analytical report containingthe results of sampling and analysis. Each individual bag or
other packaging form of the consignment shall be identifiedwith that code.
5. In the absence of such an analytical report as provided for
in paragraph 1, the feed or food business operator establishedin the Community shall have the product tested by anaccredited laboratory accredited according EN ISO/IEC 17025for the analysis of PCP in food and feed or by a laboratory thatis pursuing the necessary accreditation procedures and whichhas adequate quality control schemes in place to demonstratethat it does not contain more than 0,01 mg/kg PCP. Pendingavailability of the analytical report endorsed by a representativeof the competent authority from the country where thelaboratory is located., the product shall be detained under
official supervision for a period of no more 60 days, after
which the competent authority shall take measures as regardsthis product in accordance with Article 19(1)(a) of the Regu-lation (EC) No 882/2004 of the European Parliament and of theCouncil of 29 April 2004 on official controls performed toensure the verification of compliance with feed and food law,animal health and animal welfare rules (
2).
6. For the purposes of the test referred to in paragraphs 1
and 5, the analysis must be performed on a sample, takenrepresentatively from the consignment in accordance with theprovisions of Commission Directive 2002/63/EC of 11 July2002 establishing Community methods of sampling for theofficial control of pesticide residues in and on products ofplant and animal origin and repealing Directive79/700/EEC (
3). The extraction before analysis shall be
performed with an acidified solvent. The analysis shall becarried out according to the modified version of theQuEChERS method as set out on the website of theCommunity Reference Laboratories for Residues of Pesticides (
4)
or according to an equally reliable method.
Article 3
Sampling and analysis
1. Member States shall take the appropriate measures,
including random sampling and analysis of products referredto in Article 1 with a frequency of 5 % of the consignmentsof products referred to in Article 1, presented for first placingon the market, in order to verify that the level of 0,01 mg/kgPCP is not exceeded.
Member States shall inform the Commission through the Rapid
Alert System for food and feed of all consignments which arefound to contain PCP above 0,01 mg/kg taking into account themeasurement uncertainty.EN 1.5.2008 Official Journal of the European Union L 117/43
(1) Following the findings of the FVO, the Vimta Labs, Hyderabad,
Andhra Pradesh is the only laboratory in India which fulfils thisrequirement.(2) OJ L 165, 30.4.2004; corrected by OJ L 191, 28.5.2004, p. 1.
Regulation as last amended by Council Regulation (EC)
No 301/2008 (OJ L 97, 9.4.2008, p. 85).
(3) OJ L 187, 16.7.2002, p. 30.
(4) http://www.crl-pesticides.eu/library/docs/srm/QuechersForGuar
Gum.pdfMember States shall submit to the Commission every three
months a report of all analytical results of official controls onconsignments of products referred to in Article 1. This reportshall be submitted during the month following each quarter(April, July, October, and January).
2. Any consignment subjected to official sampling and
analysis may be detained before release onto the market for amaximum period of 15 working days.
Article 4
Splitting of a consignment
If a consignment is split, a certified copy of the analytical report
provided for in Article 2(1) and 2(5) shall accompany each partof the split consignment up to and including the wholesalestage. Certified copies of the analytical report can also beprovided by the competent authority at the moment of therelease for free circulation in case the feed or food businessoperator indicates to have the intention to split the
consignment.
Article 5
Fate of non-compliant consignments
Measures in respect of consignments of products referred to in
Article 1, which are found to contain more than 0,01 mg/kgPCP, taking into account the measurement uncertainty, shall betaken in accordance with Article 19(1)(a) of Regulation (EC) No
882/2004.
Article 6
Recovery of the costs
All costs resulting from sampling, analysis, storage or measures
following non-compliance shall be borne by the feed or foodbusiness operators concerned in accordance with Article 22 andAnnex VI of Regulation (EC) No 882/2004.Article 7
Transitional measures
By derogation from Article 2(1) and 2(5), consignments of
products referred to in Article 1, which left the country oforigin or consignment before the date of application of thisDecision, shall be accepted by the Member States even if theyare not accompanied by an analytical report as provided for inthat Article.
Article 8
Review of the measures
This Decision shall be reviewed at the latest one year after the
date of application.
Article 9
Date of application
This Decision shall apply from 5 May 2008.
Article 10
Addressees
This Decision is addressed to the Member States.
Done at Brussels, 29 April 2008.
For the Commission
Androulla VASSILIOU
Member of the CommissionEN L 117/44 Official Journal of the European Union 1.5.2008