Specific requirements for chemical contaminants data submission 1

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1 EFSA supporting publication 2014:EN-604 TECHNICAL REPORT Specific requirements for chemical contaminants data submission 1 European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT The Standard Sample Description (SSD) for food and feed is the EFSA standard for transmission of contaminant occurrence data from different data providers (Member States, Academic laboratories, Industrial stakeholders, etc.) to EFSA for use in exposure assessments. The SSD contains approximately 20 mandatory data elements (fields) that enable a unique description of each sample. For some contaminants, more detailed and specific information is necessary in order to describe the sample and analytical results. This document describes the mandatory data elements and elaborates on specific requirements for submission of occurrence data on specific chemical contaminants in food and feed to EFSA. They are valid from European Food Safety Authority, 2014 KEY WORDS SSD, Chemical contaminant, mandatory and recommended data elements, specific requirement 1 On request from EFSA, Question No EFSA-Q , approved on 20 May Correspondence: data.collection@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the members of the Scientific Network on Chemical Occurrence Data, EFSA staff members Petra Gergelová, José Ángel Gómez Ruiz, Mary Gilsenan, Chiara Guescini, Fanny Héraud, Doreen Dolores Russell, Liisa Valsta, Enikő Varga, Francesco Vernazza for the support provided to this output. Suggested citation: European Food Safety Authority, 2014; Specific requirements for chemical contaminants data submission. EFSA supporting publication 2014:EN pp. Available online: European Food Safety Authority, 2014

2 Specific requirements for chemical contaminants SUMMARY The Standard Sample Description (SSD) for food and feed is the EFSA standard for transmission of contaminant occurrence data from different data providers (Member States, Academic laboratories, Industrial stakeholders, etc.) to EFSA for use in exposure assessments. The SSD contains approximately 20 mandatory data elements (fields) that enable a unique description of each sample. For some contaminants, more detailed and specific information is necessary in order to describe the sample and analytical results. This document describes the mandatory data elements and elaborates on additional specific requirements (mandatory or recommended) for submission of occurrence data on specific chemical contaminants to EFSA. They are valid from This document is a replacement of an earlier version published on 26 March Specific requirements are updated annually to reflect the evolution of relevant legislation and in response to recommendations relating to data in EFSA s scientific opinions. Annual amendments are shared with the EFSA Scientific Network on Chemical Occurrence Data. EFSA supporting publication 2014:EN-604 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by EFSA... 4 Introduction Mandatory and recommended data elements in the SSD Requirements that apply to all data collections of chemical contaminants in food and feed Requirements that apply to specific data collections of chemical contaminants Brominated Flame Retardants Dioxins and PCBs Mineral Oils Acrylamide Furan Polycyclic aromatic hydrocarbons MCPD esters Mycotoxins Arsenic and derivatives Cadmium and derivatives Lead and derivatives Mercury and derivatives Nitrates in vegetables and other food commodities Food additives Conclusions References Appendices Acronyms EFSA supporting publication 2014:EN-604 3

4 BACKGROUND AS PROVIDED BY EFSA Specific requirements by chemical contaminants In the framework of Articles 23 and 33 of Regulation (EC) No. 178/2002 4, the European Food Safety Authority (EFSA) is mandated by the European Commission (EC) to collect, on a continuous basis, all available data on the occurrence of different chemical contaminants in food and feed. In particular, mandate M describes the scope of the continuous annual data collection of contaminants in food and feed 6. In addition, when it is necessary, ad hoc calls for data are issued on the EFSA website. INTRODUCTION The Standard Sample Description (SSD) (EFSA, 2010a) defines approximately 20 mandatory data elements (fields) to enable a unique description of an analytical sample from any specific chemical substance data collection. For some contaminants (e.g. acrylamide), more detailed and specific information is necessary to comprehensively describe the sample and analytical results for the purposes of exposure assessment. The specific requirements, which are updated annually based on new/updated legislation or recommendations pertaining to data collection in EFSA Scientific Opinions, is summarised in this document. Each mandatory data element introduced in this document should be considered as an addition to the current rules listed in Table 1 of SSD Guidance (EFSA, 2010a) and in the Guidance on Data Exchange (EFSA, 2010b) which remain valid. Any data submitted to EFSA is uploaded into EFSA s chemical contaminants database through a webbased interface, called Data Collection Framework (DCF) 7. This system validates the incoming data against a set of different business rules, described in the Guidance on Data Exchange (EFSA, 2010b); and as a part of this process DCF checks the presence of the mandatory data elements. Data with missing information, mandatory for all chemical contaminants, is rejected automatically by DCF. Data elements, mandatory only for specific contaminants (i.e. specific requirements) are checked by EFSA data managers. However absence of this specific information also results, that the respective data transmission will be rejected. Therefore, data providers are strongly encouraged to adhere to the specific requirements described in this document to avoid data rejection. 1. Mandatory and recommended data elements in the SSD The SSD contains some 80 data elements (e.g. laboratory sample code, sampling year, sampling country, etc.). Of these, approximately 20 are defined as mandatory and the remainder are recommended (e.g. list of ingredients, production method, etc.). In addition, some data elements are mandatory only for specific contaminants (e.g. for data on acrylamide it is mandatory to provide the acrylamide food code, based on the Commission Recommendation 2010/307/EU 8 ). Mandatory: information that is essential for exposure assessment (e.g. product description or analytical result value). If data are missing from a mandatory data element, the transmitted data file from a Member State data provider to EFSA will be automatically rejected. : information that is useful for an exposure assessment (e.g. Limit of qualification (LOQ) of the analytical method used). If data are missing from a recommended data element, the transmitted data file from a Member State data provider to EFSA will not be automatically 4 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, , p Commission Recommendation 2010/307/EU of 2 June 2010 on the monitoring of acrylamide levels in food. OJ L 137, , p EFSA supporting publication 2014:EN-604 4

5 rejected. However, EFSA requests data providers to provide, as much as possible, information relating to recommended data elements in order to improve the quality of exposure assessments. A change of status of a data element from recommended to mandatory or the addition of a new data element applies to data transmission of all chemical contaminants is given in Table 1. Chapter 1.1 describes requirements (mandatory or recommended) that apply to all chemical contaminants, while chapter 1.2 describes requirements that apply only to specific contaminants. Additionally, the Annexes of the current document are in a separated MS Excel table (Specific_Requirements_Annexes.xls). Annex I comprises all information contained in Table 1 to Table 18. Annex II summarises the mandatory or recommended requirements for each chemical contaminant described in detail in the current document. Annex III refers specifically to the data collection on 3-MCPD esters, and it provides the list of possible analysis steps of hydrolysis and derivatisation that should be specified in the data element analytical method text (R.11). Annex IV is linked to the specific data collection on acrylamide (Table 6) and it provides the list of food categories and sub-categories based on Commission Recommendation 2010/307/EU on the monitoring of acrylamide and Commission Recommendation 2013/647/EU 9 on investigations into the levels of acrylamide in food (Annex, point C). Annex V provides the list of additive food categories based on the Regulation (EC) No 1333/ on food additives and its amendment (Regulation (EC) No 1129/2011) 11. Table 1: Standard Sample Description data elements and their applicability to transmission of data on the occurrence of contaminants in food and feed. Status of data Element: Mandatory/ Status: Valid from Applicable to Laboratory sample code (S.01) Mandatory 2010 ALL chemical contaminants Language (S.03) Mandatory 2010 ALL chemical contaminants Country of sampling (S.04) Mandatory 2010 ALL chemical contaminants Country of origin of the product (S.06) Mandatory 2010 ALL chemical contaminants Area of origin for fisheries code (S.08) 2010 Brominated Flame Retardants (BFRs) EFSA Product code (S.12) Mandatory 2010 ALL chemical contaminants Product full text description (S.14) Mandatory 2011 ALL chemical contaminants Mandatory* 2010 *Bisphenol A (BPA) Packaging (S.16) Polycyclic aromatic hydrocarbons 2010 (PAHs) *Mandatory only in special cases or for special contaminants 9 Commission Recommendation 2013/647/EU of 8 November 2013 on investigations into the levels of acrylamide in food. OJ L 301, , p Regulation (EC) No 1333/2008 of the European Parliament and Council of 16 December 2008 on food additives. OJ L 354, , p Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives. OJ L 295, , p EFSA supporting publication 2014:EN-604 5

6 Status of data Element: Mandatory/ Status: Valid from Applicable to Product treatment (S.17) Mandatory 2010 ALL chemical contaminants Ingredients (S.20) 2010 Arsenic and derivatives, Acrylamide Product comment (S.21) Mandatory* 2012 *For Acrylamide, furan and food additives Year of sampling (S.28) Mandatory 2010 ALL chemical contaminants Month of sampling (S 29) Mandatory* *from 2015 *For Acrylamide Sampling strategy (S.33) Mandatory 2010 ALL chemical contaminants Program type (S.34) Mandatory 2010 ALL chemical contaminants Sampling method (S.35) Mandatory 2010 ALL chemical contaminants Sampling point (S.39) Mandatory 2010 ALL chemical contaminants Laboratory (L.1) 2013 ALL chemical contaminants Laboratory accreditation (L.2) Mandatory 2010 ALL chemical contaminants Result code (R.01) Mandatory 2010 ALL chemical contaminants Year of analysis (R.02) Mandatory 2010 ALL chemical contaminants Parameter code (R.06) Mandatory 2010 ALL chemical contaminants Parameter full text description Mandatory* 2010 *Only if the parameter code (R.06) is "Not in list" (a) Parameter type (R.08) Mandatory 2010 ALL chemical contaminants Analytical method code (R.10) Mandatory 2013 ALL chemical contaminants Analytical method text (R.11) Mandatory* 2013 *For 3-MCPD ester or if the analytical method code (R.10) is "Classification not possible (b) Accreditation procedure for the analytical method (R.12) 2010 ALL chemical contaminants Result unit (R.13) Mandatory 2010 ALL chemical contaminants Result LOD (R.14) Mandatory* 2010 *ALL chemical contaminants, if the Type of the result (R.27) is below "Limit of Detection (<LOD)" Result LOQ (R.15) Mandatory* *from 2015 Result value (R.18) Mandatory* 2010 Result value recovery (R.19) 2010 ALL chemical contaminants *ALL chemical contaminants, if the Type of the result (R.27) is "Numerical value" ALL chemical contaminants, but it is particularly important for mycotoxins Result value corrected for recovery (R.20) 2010 ALL chemical contaminants Result value uncertainty (R.22) 2010 ALL chemical contaminants * (a) (b) Mandatory only in special cases or for special contaminants If there is no term, in the pre-defined list of parameters, which appropriately describes a certain parameter, Not in list option can be chosen. If there is no exact term, in the predefined list of analytical methods, which describes the analytical technique used, Classification not possible option can be selected. EFSA supporting publication 2014:EN-604 6

7 Percentage of moisture in the original sample (R.23) Percentage of fat in the original sample (R.24) Status of data Element: Mandatory/ Status: Valid from Mandatory* 2010 Mandatory* 2010 Applicable to *Only, if results are expressed on 'dry weight'; 88% dry matter or 40% dry matter basis. For mineral oils and mycotoxins it is recommended also for whole weight basis. *Only, if the results are expressed in 'fat weight' basis. For BFRs, Dioxins and PCBs, 3-MCPD esters and ALL chemical contaminants; it is recommended even for whole weight basis Expression of result (R.25) Mandatory 2013 ALL chemical contaminants Type of result (R.27) Mandatory 2010 ALL chemical contaminants Legal Limit for the result (R.28) * 2014 *Food additive Type of legal limit (R.29) * 2014 *Food additive Comment of the result (R32) 2010 ALL chemical contaminants. Since the analytical result depends on the preparation condition of the food product; please report here whether the product has been prepared before the analysis and report also the preparation conditions. Applies especially for acrylamide, furan, dioxins, PCBs and mycotoxins *Mandatory only in special cases or for special contaminants 1.1. Requirements that apply to all data collections of chemical contaminants in food and feed Table 2 describes requirements which apply to occurrence data pertaining to ALL chemical contaminants submitted from Member State data providers to EFSA, irrespective of whether the contaminant is listed in this document. Table 2: Description of the mandatory and recommended requirements for ALL data collections of chemical contaminants in food and feed Laboratory sample code (S.01) Language (S.03)* Country of sampling (S.04)* Country of origin of the product (S.06)* EFSA product code (S.12)* Laboratory sample code must be identified by a unique sample identification number, not longer then 20 characters. The language used to complete the free text fields of the table must be specified. The country of sampling is the country where the commodity was selected for laboratory testing. The country of origin is the country where the commodity is originated from. It is particularly important to avoid the code unknown (XX), especially when reporting data from raw agricultural commodities. Food and feed products should be described according to the FoodEx catalogue of the SSD. It is envisaged that detailed information on the EFSA supporting publication 2014:EN-604 7

8 Product code (S.13)* Product full text description (S.14) Product treatment (S.17)* Year of sampling (S.28) Sampling strategy (S.33) Programme type (S.34)* Sampling method (S.35)* Sampling point (S.39)* Laboratory code (L.01) Laboratory accreditation (L.02)* Result code (R.01) different food groups will be needed to perform the exposure assessment. It is strongly encouraged to classify the food samples at the most detailed hierarchical level available (FoodEx level 3 and 4). This is particularly needed for food groups like Food for infants and small children and Products for special nutritional use, where any available additional descriptions shall be provided. Specific attention is needs to be given on the reporting of data on cereal grains. It is very important to make a clear distinction between grains as harvested (unprocessed grains of undefined use, not for human exposure assessment), grains for human consumption and grains as feed. For this reason three distinct groups are available within the FoodEx catalogue. Please be aware, that the Feed codes starting with F are not in use any longer G codes should be used instead. Product under analysis described according to the Matrix catalogue of the SSD that is currently available. Please note that the Matrix catalogues is created for pesticide data collection and for contaminants data collection, it is allowed to use the code XXXXXXA Not in list. Product full text description is essential to check if the EFSA product code (FoodEx code) given by the data provider is consistent with the text description. This will avoid any possible mistakes in coding and additional clarification requests. In addition as this is a free text element the information could be provided even in the national language. Original description of the sample from the national database can be copied here. It should be avoided to repeat just the FoodEx description. Moreover, any additional information that does not belong to any of the other SSD fields should be reported in S.14. It is mandatory to clearly indicate if the original sample is treated or not, especially if it is a dehydrated product (select: "Dehydration", T131A); in absence of this information it will be assumed a status as consumed. In case the sampling has been performed over a period of time the start date of sampling should be reported. It is mandatory to describe how the sample was selected from the population being monitored or surveyed. The programme type must be reported to indicate the type of control programme or other type of source to which the sample belongs. It is mandatory to define the way the samples have been collected for analysis. In case of pooled samples, the number of the sample also should be provided in Number of samples (S.36). (The default value of the number of the sample is "1"). It is obligatory to define the point of the food chain where the sample was taken. It is highly recommended to report here a unique code to identify each laboratory providing laboratory results. The laboratory code should be consistent through all the data transmissions. If more information or clarification is needed about a data, it simplifies the procedure, if the laboratory code where the analysis was performed, is reported. In accordance with Art 12 of Regulation 882/2004, laboratories designated for official controls must be accredited to ISO/IEC 17025, or avail of the derogation in Art 18 of Regulation 2076/2005. The result code should be unique for each single record. If it is not provided by the laboratory, it must be created, e.g. by merging the sample code with the parameter code. Example: a sample (Samp001) has been analysed for Mercury (RF CHE) and Cadmium (RF CHE). The created result code could be: Samp001_170 and Samp001_150. EFSA supporting publication 2014:EN-604 8

9 Year of analysis (R.02) Parameter code (R.06)* Parameter type (R.08)* Analytical method code (R.10)* Accreditation procedure for the analytical method (R.12) Result unit (R.13)* Result LOQ (R.15) Result value recovery (R.19) Result value corrected for recovery (R. 20) Result value uncertainty (R.22) Expression of result (R.25)* It is mandatory to report the year of analysis. If the analysis has been performed over a period of time the completion date of analysis should be stated. It is mandatory to code the contaminants using the code from the SSD PARAM catalogue. It is strongly encouraged to classify the parameter at the most detailed hierarchical level available. In case the parameter is not included in the PARAM catalogue the code Not in list should be reported and the name of the parameter should be specified in the Parameter Text (R.07) variable. It is mandatory to indicate whether parameter reported is an individual parameter or parameter sum. Good quality data is a fundamental component of risk assessment. From data quality perspective it is essential to know how the data have been analysed. Mandatory to specify the analytical instrument used. (Commission Regulations (EU) 252/ and 278/ ). For data quality issues it is recommended to report the accreditation procedure for the analytical method. It is obligatory to report the unit of measurement for the values reported in Result LOD, Result LOQ, Result Value, Result uncertainty, Result uncertainty standard deviation, CC alpha, CC beta or Result legal limit. Be aware that the unit of measurement should be consistent for all elements. For a proper management of the left censored data, it is mandatory to report at least the LOQ of the analytical method regardless of what is selected in data elements Result value (R.18) and Type of result (R.27). (Commission Recommendation 2007/331 14, Annex II). This data element is considered to be made mandatory starting from It is recommended to provide the recovery value associated with the concentration measurement (as a percentage) when an extraction step is applied in the analytical method. It is recommended to define if the result value has been corrected by calculation for recovery (yes/no). It is recommended to provide the expanded uncertainty (95% confidence interval) associated with the concentration measurement. Mandatory to express the results in the same units as the maximum levels laid down in Regulation (EC) 1881/ and Directive 2002/32/EC 16 : 88% dry matter for feed, Fat weight for products of terrestrial animal origin, marine oils and vegetables oils and fats, Whole weight of the products ready to use (marketed as such or after reconstitution as instructed by the manufacturer) for foods for infants and young children, 12 Commission Regulation (EU) No 252/2012 of 21 March 2012 laying down methods of sampling and analysis for the official control of levels of dioxins, dioxin- like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EC) No 1883/2006. OJ L 84, , p Commission Regulation (EU) No 278/2012 of 28 March 2012 amending Regulation (EC) No 152/2009 as regards the determination of the levels of dioxins and polychlorinated biphenyls. OJ L 91, , p Commission Recommendation 2007/331/EC of 3 May 2007 on the monitoring of acrylamide levels in food. OJ L 123, , p Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs. OJ L 364, , p Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed. OJ L 140, , p EFSA supporting publication 2014:EN-604 9

10 Type of result (R.27)* Comment of result (R.32) Clarification note on Result value (R.18), Result value recovery (R.19) and Result value corrected for recovery (R.20) Whole weight for the other food products. (Commission Regulations (EU) 252/2012 and 278/ 2012). The data elements Result value, Result qualitative value and type of result are used to describe different type of results of an analysis; therefore reporting the Type of result is mandatory for all contaminants. When the analysis is carried out after preparation of the product (dehydrated product reconstituted as consumed (infant and follow-up formulae, coffee grounded) or food cooked as consumed (precooked French fries/potato product for home cooking), report the conditions used for the preparation. The analytical results reported in the data element Result value (R.18) should reflect the best numerical value that the data provider would associate with the analytical measurement as if following Good Laboratory Practice (GLP). The reported value should reflect the most accurate estimate of the occurrence level of the chemical substance analysed, taking into account any correction for recovery as appropriate. EFSA will not apply any correction for recovery during data management but will consider the reported value as the final value to be used for data analysis and exposure assessment. For this reason, the terminology associated with the data element Result value corrected for recovery will include only an option of most accurate result value estimate. However we would still encourage the provision of additional information on the recovery of the analytical method (to be reported in Result value recovery (R.19)) to improve the quality of the assessment. *Catalogues in SSD EFSA supporting publication 2014:EN

11 1.2. Requirements that apply to specific data collections of chemical contaminants Tables 3 to 18 describe requirements which apply to occurrence data pertaining to specific contaminants submitted from Member State data providers to EFSA. For each contaminant, the status of each data element (recommended or mandatory) is defined Brominated Flame Retardants Table 3: Specific requirements for Brominated Flame Retardants data collection. Area of origin for fisheries or aquaculture activities code and text (S.08 and S.09) Parameter code (R.06) Percentage of fat in the original sample (R.24) Element (Mandatory/ Mandatory Brominated Flame Retardants If data are reported on fish, it is recommended to specify the area of origin for fisheries. When the specific information on Area of origin for fisheries or aquaculture activities code (S.08) is not available ( Unknown [M99] ) as a minimum the fish original environment should be given ( from fresh water or from salty water ) in Area of origin for fisheries or aquaculture activities text (S.09). The specific compound name (congener or stereoisomer) should be clearly specified in the field paramcode (e.g. PBDE is not valid, BDE-99 is valid). It is mandatory to provide the percentage of fat; if the result has been expressed in fat weight. Strongly recommended to always report the percentage of fat in the original sample (regardless the result value is expressed in whole weight, in fat weight or dry matter). EFSA supporting publication 2014:EN

12 Dioxins and PCBs Table 4: List of specific requirements Dioxins and DL-PCBs, non dioxin-like PCBs data collection Parameter code (R.06) Percentage of fat in the original sample (R.24) Dioxins and DL-PCBs, non dioxin-like PCBs Element (Mandatory/ Mandatory Mandatory The full set of the 29 dioxins and dioxin-like PCBs (17 PCDD/F, 12 dl-pcb), as listed in the Appendix to Annex II of the Commission Regulation (EC) 1881/2006, are mandatory when reporting results on dioxins and dioxin-like PCBs. For the non-dioxin-like PCBs, the 6 indicator congeners (PCB 28, 52, 101, 138, 153, and 180) are mandatory. It is mandatory to report analytical results at congener level. In case of reporting TEQ results, the respective original sets of results from the individual congeners must also be given. It is mandatory to report the percentage of fat in the original sample for food samples with maximum or action levels expressed on fat basis: products of terrestrial animal origin, marine oils and vegetables oils and fats (marine oils included) (Commission Regulation (EU) 252/2012 and 278/2012). It is recommended to provide the percentage of fat for the other samples, when the lipid content was determined. Comment of result (R.32) In case the sample was reconstituted before analysis, e.g. foods for infant and young children, it would be relevant to provide information on the exact reconstitution protocol (ratio dry product: added fluid (description of the fluid used) Examples: 10:90 (milk), 20:80 (water) EFSA supporting publication 2014:EN

13 Mineral Oils Table 5: List of specific requirements for Mineral Oils data collection Percentage of moisture in the original sample (R.23) Comment of result (R.32) Element (Mandatory/ Mineral Oils It is recommended to always report the percentage of moisture in the original sample (regardless of whether the result value is expressed in whole weight, in fat weight or dry matter.) The data providers are also kindly requested to report information on the molecular mass distribution expressed as number or carbon atoms (referring to n-alkanes) including: range of carbon atoms and maximum of the distribution curve EFSA supporting publication 2014:EN

14 Acrylamide Table 6: List of specific requirements for Acrylamide data collection Product full text description (S.14) Country of processing (S. 10) Product brand name (S. 18) Company, manufacturer of the product (S. 19) Product ingredients (S. 20) Product comment (S.21) Month of sampling (S 29) Result value uncertainty (R.21-22) Comment of result (R.32) Element (Mandatory/ ) Mandatory Acrylamide It is recommended to mention in the product full text description the following additional information: Potato crisps (category 2): indicate whether batch fried or continuously fried Pre-cooked French fries/home products (category 3): indicate whether the product is purchased fresh/frozen, and whether the starting material is fresh potato or potato dough Crisp bread (category 6): indicate whether the product is/isn t fermented Roasted coffee (category 7): indicate the degree of roasting (light, medium, dark) It is recommended to provide the country where the food was processed (ISO alpha-2). It is recommended to provide the product brand name. It is recommended to provide the company/ manufacturer of the product. It is recommended to provide the list of ingredients for the following food items: Potato crisps, Pre-cooked French fries, potato products for home cooking, Breakfast cereals (excluding muesli and porridge) Substitute coffee (dry) and Baby foods, other than processed cereal based foods. The different ingredients, including additives, should be separated by a $. In addition to EFSA product code (S.12), it is mandatory to provide additional product classification based on Commission Recommendation 2010/307/EU on the monitoring of acrylamide and Commission Recommendation 2013/647/EU on investigations into the levels of acrylamide in food (Annex, point C) The list of codes to be used is provided in Table 7. It is strongly recommended to classify the food samples at the most detailed hierarchical level available (food sub-categories codes). Month of sampling should be indicated for the food categories 1-3 (Potato products) based on based on Commission Recommendation 2010/307/EC on the monitoring of acrylamide (Annex, point C 1-3.) If available, information on the measurement uncertainty should be provided (range to be given in %) For the samples of the food category 3 (Pre-cooked French fries/potato product for home cooking ) e.g. pre-cooked French fries, which have to be prepared as consumed before analysis, it is relevant to provide information on the exact cooking conditions (time, temperature and handling information). In EFSA supporting publication 2014:EN

15 Element (Mandatory/ ) Acrylamide addition, if the sample has been reconstituted before analysis, e.g. instant coffee powder, foods for infant and young children, it is relevant to provide information on the exact reconstitution protocol (ratio dry product: added fluid ;description of the fluid used) Examples: 2:100 (water), 10:90 (milk), 20:80 (water). Important The official deadline for Acrylamide data submission to EFSA is by 1 June each year according to the Commission Recommendation 2010/307/EC. Table 7: List of food categories and sub-categories and respective codes based on Commission Recommendation 2010/307/EU on the monitoring of acrylamide and Commission Recommendation 2013/647/EU (Annex, point C). Codes at the most detailed hierarchical level (food sub-categories codes) must be reported in the Product comment field of the SSD (S.21) when submitting data on Acrylamide. Food category code Food subcategory code Food category and sub-food category text 1 French fries sold as ready to eat 1.1 French fries from fresh potatoes 1.2 French fries from potato dough 1.3* Unspecified French fries sold as ready to eat 2 Potato crisps and potato-based crackers 2.1 Potato crisp from fresh potatoes 2.2 Potato crisp from potato dough 2.3* Unspecified potato crisps 2.4 Potato-based crackers 3 Pre-cooked French fries, potato products for home cooking 3.1 Fries baked in the oven (oven fries) 3.2 Deep fried fries 3.3* Unspecified pre-cooked French fries, potato products for home cooking 4 Soft bread 4.1 Wheat based bread 4.2 Soft bread other than wheat based bread 4.3* Unspecified soft bread 5 Breakfast cereals (excluding porridge) 5.1 Maize, oat, spelt, barley and rice based products (a) 5.2 Wheat and rye based products (a) 5.3 Bran products and whole grain cereals, gun puffed grain (b) 5.4* Unspecified breakfast cereals (excluding porridge) 6 Biscuits, crackers, crisp bread and similar (excluding pastry and cake) 6.1 Crackers with the exception of potato based crackers EFSA supporting publication 2014:EN

16 6.2 Crisp bread 6.3 Biscuits and wafers 6.4 Gingerbread 6.5 Products similar to the other products in this category 7 Coffee and coffee substitutes 7.1 Roasted coffee (dry) 7.2 Instant coffee (dry) 7.3 Substitute coffee (dry) mainly based on cereals 7.4 Other coffee substitutes (dry) 7.5* Not specified coffee and coffee substitutes (dry) 8 Baby foods, other than processed cereal based foods 8.1 Baby foods not containing prunes 8.2 Baby foods, containing prunes 8.3* Unspecified baby foods 9 Processed cereal-based foods for infants and young children 9.1 Biscuits and rusks for infants and young children 9.2 Other processed cereal-based foods for infants and young children 9.3* Unspecified processed cereal-based foods for infants and young children 10* Other products, based on cereals, potatoes, cocoa and coffee 10.1* Porridge 10.2* Cake and pastry 10.3* Savoury snacks 10.4* Other products, based on cereals 10.5* Other products, based on potatoes 10.6* Other products, based on cocoa 10.7* Unspecified other products based on cereals, potatoes, cocoa and coffee 11* Other products, not based on cereals, potatoes, cocoa and coffee *Added by EFSA DATA Unit to improve the quality of the classification. (a): Non-whole grain and/or non-bran based cereals. The cereal present in the largest quantity determines the category. (b): Gun puffed only relevant if labelled. EFSA supporting publication 2014:EN

17 Furan Table 8: List of specific requirements for Furan data collection Product comment (S.21) Element (Mandatory/ Mandatory Furan It is mandatory to report the following information on the sample: Analysed as purchased or Analysed as consumed (Commission Recommendation 2007/196/EC 17 on the monitoring of the presence of furan in foodstuffs). Comment of result (R.32) In case the product is analysed as consumed, it is relevant to provide information on the exact cooking preparation with time, temperature and handling information (using the $ character to separate extra information). Example Analysed as consumed$heated in microwave for 60 C~1.5mins Polycyclic aromatic hydrocarbons Table 9: List of specific requirements for Polycyclic aromatic hydrocarbons (PAHs) data collection Packaging (S.16) Result value recovery (R.19) Result value uncertainty (R.22) Element (Mandatory/ Mandatory Polycyclic aromatic hydrocarbons It is mandatory to describe the container or wrapper that holds the product. Commission Regulation EC/333/ gives specific instruction to avoid certain containers when analysing PAHs. to provide the recovery value associated with the concentration measurement (as a percentage) when an extraction step is applied in the analytical method. (Commission Regulation (EC) No 333/2007). to provide the expanded uncertainty (95 % confidence interval) associated with the concentration measurement (Commission Regulation (EC) No 333/2007). 17 Commission Recommendation 2007/196/EC of 28 March 2007 on the monitoring of the presence of furan in foodstuff. OJ L 88, , p Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs. OJ L 88, , p EFSA supporting publication 2014:EN

18 MCPD esters Table 10: List of specific requirements for 3-MCPD esters data collection Parameter code (R.06) Analytical method text (R.11) Percentage of fat in the original sample (R.24) Element (Mandatory/ Mandatory Mandatory 3-MCPD esters It is mandatory to classify precisely whether the analysed parameter is 3-MCPD (Free) RF ORG 3-MCPD (From ester bounds) RF ORG or 3-MCPD (Sum free and bound) RF ORG. It is mandatory to clarify whether the samples has been analysed as such or analysed after hydrolysis, derivatisation It is recommended to describe in detail the applied analysis steps (hydrolysis, derivatisation) by introducing the appropriate code/codes in this data element as provided in Table 11. The recommended methods for MCPD-ester analysis are the three methods validated by American Oil Chemists Society (AOCS) in October 2013 (AOCS, 2013). It is recommended to always report the percentage of fat in the original sample (regardless of whether the result value is expressed in whole weight, in fat weight or dry matter). Specific information on the analytical method applied might be important in considering the data for risk assessment. Therefore data providers are asked to give information on the applied analysis steps (hydrolysis, derivatisation) by introducing the appropriate code/codes in the field analytical method text (R.11) as provided in Table 11. If more options are to be introduced they have to be separated by the symbol $ (example: 2$8 if results were obtained by a method applying cleavage of 3-MCPD esters with sodium methoxide and derivatisation with phenylboronic acid). The recommended methods for MCPD-ester analysis are the three methods validated by American Oil Chemists Society (AOCS) in October Table 11: List of codes for hydrolysis and derivatisation steps that might be applied for the analysis of 3-MCPD esters. Code AOCS1 AOCS2 AOCS3 Applied analysis step AOCS validated methods for MCPD esters AOCS Official Method Cd 29a : 2- and 3-MCPD Fatty Acid Esters and Glycidol Fatty Acid Esters in Edible Oils and Fats by Acid Transesterification AOCS Official Method Cd 29b : Determination of Bound Monochloropropanediol- (MCPD-) and Bound 2,3-epoxy-1-propanol (glycidol-) by Gas Chromatography/Mass Spectrometry (GC/MS) AOCS Official Method Cd 29c : Fatty-acid-bound 3-chloropropane-1,2,diol (3-MCPD) and 2,3-epoxi-propane-1-ol (glycidol), Determination in Oils and Fats by GC/MS (Differential Measurement) EFSA supporting publication 2014:EN

19 Hydrolysis cleavage of esters Alkaline transesterification cleavage of esters with sodium methoxide; destruction of glycidol with acid (before transesterification) DGF method Alkaline transesterification cleavage of esters with sodium methoxide; without destruction of glycidol (original Weisshaar's method) Alkaline transesterification cleavage of esters with sodium methoxide; application of aqueous solutions containing sodium chloride Alkaline transesterification cleavage of esters with sodium methoxide; application of aqueous solutions without sodium chloride, but containing other salts Alkaline transesterification cleavage of esters with sodium methoxide; application of organic solvents 6 Acidic hydrolysis with methanolic sulphuric acid 7 Other hydrolysis method (provide its description in a separate file) Derivatisation 8 Derivatisation with phenylboronic acid (PBA) 9 Derivatisation with heptafluorobutyrylimidazole 10 Derivatisation with acetone 11 Other derivatisation method (provide its description in a separate file) EFSA supporting publication 2014:EN

20 Mycotoxins Table 12: List of specific requirements for Mycotoxins data collection EFSA product code (S.12) Method of production (S.15) Result value recovery (R.19) Result value uncertainty (R.22) Percentage of moisture in the original sample (R.23) Comment of result (R.32) Element (Mandatory/ Mandatory Mycotoxins It is important to classify the food/feed samples of grains at the most detailed FoodEx level available. This is particularly needed for Grains and grain-based products and Food for infants and small children. It is recommended to report whether the sample was obtained from the produce of traditional (non-organic) or organic farming It is recommended to provide the recovery value associated with the concentration measurement (as a percentage) (Commission Regulation (EC) No 401/ ). It is recommended to provide the expanded uncertainty (95 % confidence interval) associated with the concentration measurement (Commission Regulation (EC) No 401/2006). It is recommended to report the percentage of moisture in the original sample of feed and for processed cereals based foods for infant and young children. In case the sample was reconstituted before analysis, e.g. infant formulae and follow-on formulae, it would be relevant to provide information on the exact reconstitution protocol (ratio dry product: added fluid (description of the fluid used) Examples: 14:86 (water). 22 Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs. OJ L 70, , p EFSA supporting publication 2014:EN

21 Arsenic and derivatives Table 13: List of specific requirements for Arsenic and derivatives data collection Product full text description (S.14) Element (Mandatory/ Arsenic and derivatives It is important to provide this information when an EFSA product code is not available. This is especially important for instance when providing information on seaweed to identify the presence of the alga Hijiki. Product treatment (S.17) Ingredient (S.20) Parameter code (R.06) Mandatory Reporting data on rice (as grains for human consumption). In order to be able to distinguish raw rice and rice that has undergone any kind of treatment, the product treatment (S.17) is mandatory to provide at least the codes for unprocessed or processed respectively). In case "processed" is selected the type of preparation should be described in Comment of result (R.32). Additionally, it is recommended to clearly indicate if the original sample is a dehydrated product (select: "Dehydration", T131A). Reporting of rice based products. If a product contains rice (e.g. ready to eat meal for children, cereal based; rice cake) it should be specified in this field, together with the details on the variety of rice, if known. Furthermore, it is recommended to describe the type of alga included in alga-based foods for special nutritional use. It is strongly recommended to report Arsenic speciation data. Please, specify at least if the analysis refer to Total, Inorganic or Organic Arsenic. EFSA supporting publication 2014:EN

22 Cadmium and derivatives Table 14: List of specific requirements for Cadmium and derivatives data collection Result value recovery (R.19) Element (Mandatory/ Cadmium and derivatives It is recommended to provide the recovery value associated with the concentration measurement (as a percentage) when an extraction step is applied in the analytical method. (Commission Regulation (EC) No 333/2007). Result value uncertainty (R.22) It is recommended to provide the expanded uncertainty (95 % confidence interval) associated with the concentration measurement (Commission Regulation (EC) No 333/2007) Lead and derivatives Table 15: List of specific requirements for Lead and derivatives data collection Element (Mandatory/ Lead and derivatives Result value recovery (R.19) Result value uncertainty (R.22) It is recommended to provide the recovery value associated with the concentration measurement (as a percentage) when an extraction step is applied in the analytical method (Commission Regulation (EC) No 333/2007). It is recommended to provide the expanded uncertainty (95% confidence interval) associated with the concentration measurement (Commission Regulation (EC) No 333/2007). EFSA supporting publication 2014:EN

23 Mercury and derivatives Table 16: List of specific requirements for Mercury and derivatives data collection Area of origin for fisheries or aquaculture activities code and text (S.08 and S.09) EFSA product code (S.12) Parameter code (R.06) Element (Mandatory/ Mercury and derivatives If data are reported on fish, it is recommended to specify the area of origin for fisheries. In case, the specific information on Area of origin for fisheries or aquaculture activities code (S.08) is not available ( Unknown [M99] ) at least the fish original environment should be given ( from fresh water or from salty water ) in Area of origin for fisheries or aquaculture activities text (S.09). It is particularly important to classify the samples of fish meat, seafood and fish/seafood products at the most detailed FoodEx level available. It is strongly recommended to report Mercury speciation data. Please, specify at least if the analysis refer to the elemental Mercury, Inorganic Mercury, Organic Mercury (e.g. Methylmercury) Nitrates in vegetables and other food commodities Table 17: List of specific requirements for Nitrates in vegetables and other food commodities data collection Result value recovery (R.19) Nitrates in vegetables and other food commodities Element (Mandatory/ It is recommended to provide the recovery value associated with the concentration measurement (as a percentage). (Commission Regulation (EC) No 1882/ ). Result value uncertainty (R.22) It is recommended to provide the expanded uncertainty (95 % confidence interval) associated with the concentration measurement (Commission Regulation (EC) No 1882/2006). 23 Commission Regulation (EC) No 1882/2006 of 19 December 2006 laying down methods of sampling and analysis for the official control of the levels of nitrates in certain foodstuffs. OJ L 364, , p EFSA supporting publication 2014:EN

24 Food additives Table 18: List of specific requirements for food additives data collection Product comment (S.21) Product comment (S.21) Type of legal limit (R.29) Legal Limit for the result (R.28) Element (Mandatory/ ) Mandatory Food Additives In addition to EFSA product code (S.12), it is mandatory to provide additional product classification (Food additive code) based on the Regulation 1333/2008 of the European Parliament and Council of 16 December 2008 on food additives. The list of codes to be used is provided in Annex V. It is strongly recommended to classify the food samples at the most detailed hierarchical level available (food sub-categories codes). It is recommended to report Maximum Limit (ML) if there is a Maximum Permitted Level (MPL) defined in the Regulation 1333/2008 for the food additive in the reported food category. It is recommended to provide the Maximum Permitted Level (MPL), if it is defined in the Regulation 1333/2008 for the food reported additive in the reported food category. CONCLUSIONS The objective of this EFSA protocol is to guide and support data providers with the submission of specific chemical contaminants occurrence information. It was developed as a reference source that can be used by data providers to verify that the specified data elements concerning the relevant chemical contaminant are included in their submissions in compliance with the EFSA data model (SSD). The specific data elements are compatible with EFSA s data transmission business rules: an advantage to both data provider and EFSA in reducing the risk of incomplete data transmission and resulting follow-up requests to the data provider. In establishing a standardised process for the submission of specific requirements by chemical contaminants, it is EFSA s intention to enable an efficient and effective collection and submission process for chemical occurrence data in food and feed. REFERENCES AOCS (American Oil Chemists Society), Online. AOCS Validates Methods for MCPD Ester Analysis. Available online: EFSA (European Food Safety Authority), 2010a. Standard Sample Description for Food and Feed. EFSA Journal 2010;8(1):1457, 54 pp. doi: /j.efsa EFSA (European Food Safety Authority), 2010b. Guidance on Data Exchange. EFSA Journal 2010;8(11):1895, 50pp. doi: /j.efsa APPENDICES Please see the attached MS Excel document (Specific_Requirements_Annexes.xls). EFSA supporting publication 2014:EN

25 ACRONYMS AOCS American Oil Chemists Society DCF EC Data Collection Framework European Commission EFSA European Food Safety Authority LOD LOQ MPL MS SSD Limit of Detection Limit of Qualification Maximum Permitted Level Member States Standard Sample Description EFSA supporting publication 2014:EN