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On April 15 2016, the European Commission published Regulation (EU) 2016/582 [1], amending Regulation (EC) No 333/2007 [2], concerning the analysis of inorganic arsenic, lead and polycyclic aromatic hydrocarbons (PAHs) in foodstuffs and certain performance criteria for analysis.

Regulation (EU) 2015/1006 [3], amends Regulation (EC) No 1881/2006 [4] concerning Maximum Limits (ML) for inorganic arsenic in food, describing specific procedures related to analysis for inorganic arsenic, and updates EN standard 13804 related to the determination of elements and their chemical species. Consequently, Regulation (EC) No 333/2007 is amended as follows:

  • The title of Regulation (EC) No 333/2007 is changed to “Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs”
  • Specific procedures for lead, cadmium, mercury, inorganic tin and inorganic arsenic (point C.2.2.1) are added to Standard EN 13804:2013, “Foodstuffs. Determination of elements and their chemical species. General considerations and specific requirements”, which has been found to be satisfactory for specific sample preparation, although other sample preparation methods may be equally valid
  • Following the advice of the EU reference laboratory, the definition of LOQ is amended to “LOQ = Limit of quantification, lowest content of the analyte which can be measured with reasonable statistical certainty.  If both accuracy and precision are constant over a concentration range around the limit of detection, then the limit of quantification is numerically equal to 10 times the standard deviation of the mean of blank matrix determination (n≥ 20)”
  • Performance criteria related to the limit of detection for methods of analysis for lead, cadmium, mercury, inorganic tin and inorganic arsenic, are amended in table 5 (point C.3.3.1) to the following:
  • Parameter Criterion
    Applicability Food specified in Regulation (EC) No 1881/2006
    Specificity Free from matrix or spectral interferences
    Repeatability (RSDr) HORRATr less than 2
    Reproducibility (RSDR) HORRATR less than 2
    Recovery The provision of point D.1.2 apply
    LOD = three tenths of LOQ
    LOQ Inorganic tin ≤ 10 mg/kg
    Lead ML ≤ 0.01 mg/kg 0.01 < ML
    ≤ 0.02
    0.02 < ML
    < 0.1
    ML ≥ 0.1 mg/kg
    ≤ ML ≤ two thirds of
    the ML
    ≤ two fifths of
    the ML
    ≤ one fifths of
    the ML
    Cadmium, mercury, inorganic arsenic ML is < 0.100 mg/kg ML is ≥ 0.100 mg/kg
    ≤ two fifths of the ML ≤ one fifths of the ML'
  • General requirements (point C.3.2) have some amendments such as additional information about “Methods for analysis for total arsenic are appropriate for screening purposes for control of inorganic arsenic levels. If the total arsenic concentration is below the maximum level for inorganic arsenic, no further testing is required and the sample is considered to be compliant with the maximum level for inorganic arsenic. If the total arsenic concentration is at or above the maximum level for inorganic arsenic, follow-up testing shall be conducted to determine if the inorganic arsenic concentration is above the maximum level for inorganic arsenic”

In addition, information is added to Regulation (EC) No 333/2007 relating to specific procedures for PAHs (point C.2.2.2) to harmonize the methods for the determination of fat content. This is because MLs for PAH in cocoa beans and derived products must be established on the basis of fat content and proficiency tests performed by the EU Reference Laboratory for PAH indicate divergences in the determination of fat content. The additional information is: “For the analysis of PAH in cocoa and cocoa derived products, the determination of the fat content is performed in accordance with AOAC Official method 963.15 for the determination of the fat content of cocoa beans and derived products. Equivalent fat determination procedures can be applied for which it can be demonstrated that the used fat determination procedure provides an equal (equivalent) fat content value.”

This Regulation entered into force on May 5, 2016.

What do the changes mean?

EU Member States, food business operators in the EU and importers/exporters to the EU must check and ensure that their methods of sampling and analysis for controlling levels of trace elements, their chemical species and polycyclic aromatic hydrocarbons in foodstuffs, comply with this Regulation. For more information, or to discuss your testing, analysis and certification requirements contact a food safety expert, such as SGS.

SGS is committed to keeping you informed of regulation news and developments. Leveraging our global network of laboratories and food experts, SGS provides a comprehensive range of food safety and quality solutions including analytical tests, audits, certifications, inspections, and technical support. We continually invest in our testing, capability, and state-of-the art technology to help you reduce risk, and to improve food safety and quality. For more information, please visit our website:

For enquiries, please contact:

Naovarat Dachprasat
Food Technical Support Center
t: +66 2683 0541 ext 2168

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