Specific reporting requirements for contaminants and food additives occurrence data submission

Transcription

1 TECHNICAL REPORT APPROVED: 15 June 2017 doi: /sp.efsa.2017.en-1262 Specific reporting requirements for contaminants and food additives occurrence data submission Abstract European Food Safety Authority (EFSA) EFSA requires data on the occurrence of chemicals in food to undertake dietary exposure assessments. The Standard Sample Description (SSD) for food and feed is the EFSA standard for transmission of chemical occurrence data from different data providers (Member States, academic laboratories, industrial stakeholders, etc.) to EFSA. The SSD contains approximately 20 mandatory data elements (fields) that enable a unique description of each sample. For some chemicals, 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 reporting requirements for submission of analytical occurrence data on specific contaminants in food and feed as well as food additives to EFSA. It updates and replaces a previous version published in June 2015 in response to recommendations relating to data in EFSA s Scientific Opinions. Reporting requirements are valid from 2017 data transmission year. European Food Safety Authority, 2017 Key words: SSD, chemical contaminants, food additives, mandatory and recommended data elements, specific requirements Requestor: EFSA Question number: EFSA-Q Correspondence: data.collection@efsa.europa.eu EFSA Supporting publication 2017:EN-1262

2 Acknowledgements: EFSA wishes to thank the following for the support provided to this scientific output: Andrea Altieri, Davide Arcella, Valentina Bocca, Petra Gergelova, Jose Angel Gomez Ruiz, Ilaria Magliano, Eniko Varga, Francesco Vernazza. Suggested citation: EFSA (European Food Safety Authority), Specific reporting requirements for contaminants and food additives occurrence data submission. EFSA supporting publication 2017: EN pp. doi: /sp.efsa.2017.en-1262 ISSN: European Food Safety Authority, 2017 Reproduction is authorised provided the source is acknowledged. 2 EFSA Supporting publication 2017:EN-1262

3 Summary EFSA requires data on the occurrence of chemicals in food to undertake dietary exposure assessments. The Standard Sample Description (SSD) for food and feed is the EFSA standard for transmission of chemical occurrence data from different data providers (Member States, academic laboratories, industrial stakeholders, etc.) to EFSA. The SSD contains approximately 20 mandatory data elements (fields) that enable a unique description of each sample. For some chemicals, 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 reporting requirements for submission of occurrence data on specific chemical contaminants in food and feed as well as food additives to EFSA. This document updates and replaces a previous version published on 30 June 2015 (EFSA supporting publication: EN-833) in response to recommendations relating to data in EFSA s Scientific Opinions. Updates to reporting requirements are shared with the EFSA Scientific Network on Chemical Occurrence Data during its annual general meeting prior to updating this technical report. The following updates to specific reporting requirements, highlighted with a change bar in the text, are included in the present report: The mandatory/recommended status of some data elements has been updated (Table 1: ); Information and accompanying text relating to the analytical methods for MCPDs and Glycidyl esters reporting has been updated (Table 10: & Table 11: ); The reporting rules of paramcode terms (PARAM catalogue) have been revised. Aggregated terms, such as Dioxins, Mycotoxins etc., are not reportable. The reportability of PARAM terms is shown in Annex VIII and Annex IX of this report, for contaminants and food additives, respectively. Not reportable terms have been flagged with 0 in chemoccrepreportable and addreportable columns, respectively; The unit of measurement (UNIT catalogue) has also been revised. In contaminants and food additives occurrence data collections only units that can be converted into the standard unit micrograms/kilogram are accepted. Acceptable UNIT terms are shown in Annex X of this report; A syntax on how to report information in Product comment has been defined (Table 2: ). 3 EFSA Supporting publication 2017:EN-1262

4 Table of contents Abstract... 1 Summary Introduction Background as provided by EFSA Additional information and recommended data elements in the SSD Reporting requirements applying to all contaminants and food additives Reporting requirements applying to specific data collection of contaminants Brominated Flame Retardants Dioxins and PCBs Mineral Oils Acrylamide Furan Polycyclic aromatic hydrocarbons MCPDs, 2-MCPDs and Glycidyl esters Mycotoxins Arsenic and derivatives Cadmium and derivatives Lead and derivatives Mercury and derivatives Nitrates in vegetables and other food commodities Chlorate and perchlorate Reporting requirements applying to specific data collection of food additives occurrence Conclusions References Abbreviations Annex EFSA Supporting publication 2017:EN-1262

5 1. Introduction 1.1. Background as provided by EFSA In the framework of Articles 23 and 33 of Regulation (EC) No. 178/2002, as last amended 1, the European Food Safety Authority (EFSA) is mandated by the European Commission (EC) to collect all available data on the occurrence of different chemical contaminants in food and feed. In particular, mandate M describes the scope of the annual data collection of contaminants in food and feed. Regulation (EC) No 1333/ on food additives requires that food additives are subject to a safety evaluation by the EFSA before they are permitted for use in the European Union. In addition food additives must be kept under continuous observation and must be re-evaluated by EFSA. For this purpose, a programme for the re-evaluation of food additives that were already permitted in the European Union before 20 January 2009 has been set up under Regulation (EC) No 257/ This Regulation also foresees that food additives are re-evaluated whenever necessary in light of changing conditions of use and new scientific information. Ad hoc calls for food additives data are published on the EFSA website in accordance with the timeframe of the re-evaluation programme Additional information The Standard Sample Description (SSD) (EFSA, 2010a) is the EFSA standard for receipt of chemical occurrence data. It defines approximately 20 mandatory data elements (fields) to enable a unique description of an analytical sample from a 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 reporting requirements, which are updated on regular basis in response to recommendations pertaining to data collection in EFSA Scientific Opinions, are summarised in this document. Each mandatory data element described in this document should be considered as an addition to the current rules listed in Table 1 of the SSD Guidance (EFSA, 2010a) and in the Guidance on Data Exchange (EFSA, 2010b) which remain valid until the replacement with the updated versions of SSD Guidance (SSD2; EFSA, 2013) and Guidance of Data Exchange (GDE2; EFSA, 2014) will be fully implemented. Data submitted to EFSA is uploaded into EFSA s chemical contaminants database through a webbased interface, called Data Collection Framework (DCF) 5. This system validates the incoming data against a set of different business rules, described in the Guidance on Data Exchange (EFSA, 2010b) (general business rules) and in the current document (specific requirements). As a part of this process the DCF checks the presence of the mandatory data elements. Data elements with missing information, both mandatory for all chemical contaminants and for specific contaminants (i.e. specific requirements), are rejected automatically by the DCF. Therefore, data providers are required to adhere to the specific reporting requirements described in this document to avoid data rejection. 1 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January2002 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 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. OJ L 354, , p No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives OJ L 80, , p EFSA Supporting publication 2017:EN-1262

6 2. and recommended data elements in the SSD The SSD contains 76 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 product categories, based on the Commission Recommendation 2010/307/EU). : 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 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. Section 2.1 describes reporting requirements (mandatory or recommended) that apply to all chemical contaminants, while sections 2.2 and 2.3 describe requirements that apply only to specific contaminants and food additives, respectively. Additionally, the Annexes of the current document are in separate worksheets of a MS Excel file (Specific_Requirements_2016_data_Annexes.xlsx) accompanying this document on EFSA s website. Annex I comprises all information contained in Table 1 to Table 19. Annex II summarises the mandatory or recommended requirements for each chemical contaminant and food additive described in detail in the current document. Annex III refers specifically to the data collection on MCPDs and Glycidyl esters, and it provides the list of possible methods validated by American Oil Chemists Society (AOCS) in October 2013 (AOCS, 2013) 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 product categories and sub-categories based on Commission Recommendation 2010/307/EU 6 on the monitoring of acrylamide and Commission Recommendation 2013/647/EU 7 on investigations into the levels of acrylamide in food (Annex, point C in the legislation). Annex V provides the list of additive food categories. Annex VI and Annex VII contain the specific business rules for contaminants and food additives data collections, respectively. Annex VIII and Annex IX contain the specific hierarchies of the PARAM catalogue to be used for contaminants and food additives data collection, respectively. Annex X contains the revised UNIT catalogue to be used for contaminants and food additives data collections. Table 1: Standard Sample Description data elements recommended or mandatory in the different domains, applicable to transmission of data on the occurrence of contaminants and food additives SSD Data Status of data : / Status: Valid from Applicable to Laboratory sample code (S.01) 2010 ALL chemical contaminants Language (S.03) 2010 ALL chemical contaminants Country of sampling (S.04) 2010 ALL chemical contaminants Country of origin of the product (S.06) Area of origin for fisheries code (S.08) 2010 ALL chemical contaminants 2016 Brominated Flame Retardants (BFRs), Dioxins, Mercury and derivatives 6 Commission Recommendation 2010/307/EU of 2 June 2010 on the monitoring of acrylamide levels in food. OJ L 137, , p Commission Recommendation 2013/647/EU of 8 November 2013 on investigations into the levels of acrylamide in food. OJ L 301, , p EFSA Supporting publication 2017:EN-1262

7 SSD Data Status of data : / Status: Valid from Applicable to EFSA Product code (S.12) 2010 ALL chemical contaminants Product code (S.13) 2011 ALL chemical contaminants Product full text description (S.14) 2011 ALL chemical contaminants Packaging (S.16) * 2016 *Bisphenol A (BPA), PAHs Product treatment (S.17) 2010 ALL chemical contaminants Ingredients (S.20) 2010 Arsenic and derivatives, Acrylamide Product comment (S.21) * 2012 *Acrylamide, furan and food additives; Product comment (S.21) * 2016 *Chlorate and perchlorate if the Product treatment (S.17) is processed Year of sampling (S.28) 2010 ALL chemical contaminants Month of sampling (S 29) * 2016 *Acrylamide Sampling strategy (S.33) 2010 ALL chemical contaminants Programme type (S.34) 2010 ALL chemical contaminants Sampling method (S.35) 2010 ALL chemical contaminants Sampling point (S.39) 2010 ALL chemical contaminants Laboratory (L.1) 2013 ALL chemical contaminants Laboratory accreditation (L.2) 2010 ALL chemical contaminants Result code (R.01) 2010 ALL chemical contaminants Year of analysis (R.02) 2010 ALL chemical contaminants Parameter code (R.06) 2010 ALL chemical contaminants Parameter full text description * 2010 *ALL chemical contaminants if the parameter code (R.06) is "Not in list" 8 Parameter type (R.08) 2010 ALL chemical contaminants Analytical method code (R.10) 2013 ALL chemical contaminants Analytical method text (R.11) * 2013 * 3-MCPD esters Analytical method text (R.11) * 2013 Accreditation procedure for the analytical method (R.12) *ALL chemical contaminants if the analytical method code (R.10) is "Classification not possible (a) 2010 ALL chemical contaminants Result unit (R.13) 2010 ALL chemical contaminants Result LOD (R.14) * 2010 *ALL chemical contaminants, if the Type of the result (R.27) is below "Limit of Detection (<LOD)" Result LOQ (R.15) 2016 ALL chemical contaminants Result value (R.18) * 2010 Result value recovery (R.19) 2010 Result value corrected for recovery (R.20) Result value uncertainty (R.22) *ALL chemical contaminants, if the Type of the result (R.27) is "Numerical value" ALL chemical contaminants, but it is particularly important for mycotoxins 2010 ALL chemical contaminants 2010 ALL chemical contaminants 8 If there is no term in the pre-defined list of parameters, which appropriately describes a certain parameter, the Not in list option shouldn t be used; the data provider is kindly asked to send an to Catalogues@efsa.europa.eu mailbox to request the insertion of the missing term. 7 EFSA Supporting publication 2017:EN-1262

8 SSD Data Percentage of moisture in the original sample (R.23) Percentage of fat in the original sample (R.24) Status of data : / Status: Valid from * 2010 * 2010 Applicable to *ALL chemical contaminants if results are expressed on a 'dry weight'; 88% dry matter or 40% dry matter basis. *ALL chemical contaminants if the results are expressed on a 'fat weight' basis. Percentage of fat in the original sample (R.24) * 2016 *BFRs, Dioxins and PCBs, 3-MCPD esters, even if the results are expressed on a whole weight basis Expression of result (R.25) 2013 ALL chemical contaminants Type of result (R.27) 2010 ALL chemical contaminants Comment of the result (R32) 2010 * / for particular chemical contaminants 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 (a) If there is no exact term in the pre-defined list of analytical methods, which describes the analytical technique used, the Classification not possible option can be selected Reporting requirements applying to all contaminants and food additives Table 2 describes reporting requirements which apply to occurrence data pertaining to ALL contaminants and food additives submitted from Member State data providers to EFSA, irrespective of whether a substance is listed in this document. Table 2: Reporting requirements for ALL contaminants in food and feed and food additives SSD Data 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)* Description/requirements Laboratory sample code must be identified by a unique sample identification number, not longer than 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 originates 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 different food groups will be needed to perform the exposure assessment. It is mandatory to report at least the level 2 of the FoodEx code. 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 needs to be given to the reporting of data on cereal 8 EFSA Supporting publication 2017:EN-1262

9 SSD Data 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) Year of analysis (R.02) Description/requirements 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 catalogue 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 the absence of this information the status as consumed will be assumed. 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 sample, it simplifies the procedure if the laboratory code where the analysis was performed is reported. In accordance with Article 12 of Regulation 882/2004 9, laboratories designated for official controls must be accredited to ISO/IEC 17025, or avail of the derogation in Article 18 of Regulation 2076/ 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. 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. 9 Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. OJ L 165, , p Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004. OJ L 338, , p EFSA Supporting publication 2017:EN-1262

10 SSD Data Parameter code (R.06)* Parameter type (R.08)* Description/requirements 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 not be reported and an to mailbox should be sent to request the insertion of the missing term. It is mandatory to indicate whether parameter reported is an individual parameter or parameter sum. Analytical method code (R.10)* It is mandatory to specify the analytical instrument used (Commission Regulations (EU) 252/ and 278/ ). 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)* Type of result (R.27)* Comment on result (R.32) 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 the management of left censored data, it is highly recommended 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). 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 report if the result value has been corrected for recovery (yes/no). It is recommended to provide the expanded uncertainty (95% confidence interval) associated with the concentration measurement. It is mandatory to express the results in the same units as the maximum levels laid down in Regulation (EC) 1881/ and Directive 2002/32/EC 14 : 88% dry matter for feed, Fat weight for products of terrestrial animal origin, marine oils and vegetable 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, 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 (e.g. 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), it is recommended to report the 11 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 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 2017:EN-1262

11 SSD Data Description/requirements conditions used for the preparation. Clarification note on Result value (R.18), Result value recovery (R.19) and Result value corrected for recovery (R.20) 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 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. Product comment is used to report additional requested information, to identify a food product. To ease the process of data extraction and analysis from this free text field the following syntax is defined and should be followed by data providers. Each piece should include a header identifying the type of information reported followed by the equal sign and its value. Different types of information should be separated by a double ash ##, as reported in the examples in the table below. The list of allowed headers and their allowed values is shown in the following table (please note that headers are not case sensitive and spaces are not allowed): Product comment (S.21) Header Reference Example foodex2 product classification according to FoodEx2 foodex2=a011n#f19. A07PR$F02.A0EJN foodcatacrylami de additional product classification based on Commission Recommendation 2010/307/EU on the monitoring of acrylamide foodcatacrylamide =1.2 furananalysis analysis detail based on Commission Recommendation 2007/196/EC on the monitoring of the presence of furan in foodstuffs (analysed as consumed or as purchased ) foodcatm42 additional product classification (food category codes) based Commission Regulation (EC) No 1333/2008 on food additives, as amended treat treatment of the product (mandatory when reporting data on chlorates/perchlorates and prodtreat is processed ) comment any other comment that data providers wish to report furananalysis=as consumed foodcatm42= treat=washing with recycled water comment=heated in microwave Overall Examples: - FoodEx2=A011N#F19.A07PR##foodCatAcrylamide=3.1##commen t=oven180 C~23min## - FoodEx2=A03GV#F28.A07MK##furanAnalysis=Analysed as consumed## *Denotes catalogues in SSD 11 EFSA Supporting publication 2017:EN-1262

12 2.2. Reporting requirements applying to specific data collection of 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: for Brominated Flame Retardants data collection SSD Data Area of origin for fisheries or aquaculture activities code and text (S.08 and S.09) 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). Parameter code (R.06) Percentage of fat in the original sample (R.24) Please see reporting rules in Annex VIII (column f). It is mandatory to provide the percentage of fat if the result has been expressed on a fat weight basis. It is strongly recommended to always report the percentage of fat in the original sample (regardless the result value is expressed on a whole weight, on fat weight or dry matter) EFSA Supporting publication 2017:EN-1262

13 Dioxins and PCBs Table 4: List of specific requirements for Dioxins and DL-PCBs, non dioxin-like PCBs data collection SSD Data Area of origin for fisheries or aquaculture activities code and text (S.08 and S.09) Dioxins and DL-PCBs, non dioxin-like PCBs 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). EFSA product code (S.12) Product full text description (S.14) Product comment (S.21) Year, month and day of production (S.22-24) FoodEx code is mandatory to report for ALL contaminants. It is particularly important to classify the samples of fish meat and fish products at the most detailed FoodEx level available. Product full text description is mandatory to report for ALL contaminants. If data are reported on fish, it is strongly recommended to precisely report the analysed fish species, especially fish originated from the Baltic region. If data are reported on fish, it is recommended to report the length and/or weight of the fish samples (measurement Regulation (EC) 850/98 15 and Regulation (EC) 2187/ If data are reported on fish, it is recommended to report here, when the fish has been caught. Parameter code (R.06) Percentage of fat in the original sample (R.24) 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 six indicator congeners (PCB 28, 52, 101, 138, 153, and 180) are mandatory. It is mandatory to report analytical results at congener level. Please see reporting rules in Annex VIII (column f). It is highly recommended to report the percentage of fat in the original sample for food samples with maximum or action levels expressed on a 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. 15 Council Regulation (EC) No 850/98 of 30 March 1998 for the conservation of fishery resources through technical measures for the protection of juveniles of marine organisms. OJ L 125, , p Council Regulation (EC) No 2187/2005 of 21 December 2005 for the conservation of fishery resources through technical measures in the Baltic Sea, the Belts and the Sound, amending Regulation (EC) No 1434/98 and repealing Regulation (EC) No 88/98. OJ L 349, , p EFSA Supporting publication 2017:EN-1262

14 SSD Data Comment of result (R.32) Dioxins and DL-PCBs, non dioxin-like PCBs In case the sample was reconstituted before analysis, e.g. foods for infants and young children, it is recommended to provide relevant information on the exact reconstitution protocol (ratio dry product: added fluid (description of the fluid used) Examples: 10:90 (milk), 20:80 (water) Mineral Oils Table 5: List of specific requirements for Mineral Oils data collection SSD Data Percentage of moisture in the original sample (R.23) Comment of result (R.32) 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 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 14 EFSA Supporting publication 2017:EN-1262

15 Acrylamide Table 6: List of specific requirements for Acrylamide data collection SSD Data Product full text description (S.14) Country of processing (S. 10) Product ingredients (S. 20) Product comment (S.21) Month of sampling (S 29) Result value uncertainty (R.21-22) Comment of result (R.32) ) 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 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 17 on investigations into the levels of acrylamide in food (Annex, point C). The list of codes to be used is provided in Table 7. The syntax on how to report the code is defined in Table 2:. 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 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 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). 17 Commission Recommendation No 2013/647/EU of 8 November 2013 on investigations into the levels of acrylamide in food. OJ L 301, , p EFSA Supporting publication 2017:EN-1262

16 Important The official deadline for Acrylamide data submission to EFSA is by 1 June each year according to the Commission Recommendation (2010/307/EU). Table 7: List of food categories, 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) on investigations into the levels of acrylamide in food. Codes at the most detailed hierarchical level (food sub-category 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 1 French fries sold as ready to eat 1.1 French fries from fresh potatoes 1.2 French fries from potato dough Food category and sub-food category text 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) 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) Biscuits, crackers, crisp bread and similar (excluding pastry and cake) 6.1 Crackers with the exception of potato based crackers 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) 16 EFSA Supporting publication 2017:EN-1262

17 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 Evidence Management (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 2017:EN-1262

18 Furan Table 8: List of specific requirements for Furan data collection SSD Data Furan Product comment (S.21) It is mandatory to report the following information on the sample: Analysed as purchased or Analysed as consumed (Commission Recommendation 2007/196/EC 18 on the monitoring of the presence of furan in foodstuffs). The syntax on how to report the information is defined in Table 2:. 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 Heated in microwave at 60 C$1.5mins Polycyclic aromatic hydrocarbons Table 9: List of specific requirements for Polycyclic aromatic hydrocarbons (PAHs) data collection Polycyclic aromatic hydrocarbons SSD Data Packaging (S.16) Result value recovery (R.19) Result value uncertainty (R.22) It is mandatory to describe the container or wrapper that contains the product. Commission Regulation (EC) No 333/ gives specific instructions to avoid certain containers when analysing PAHs. 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). 18 Commission Recommendation No 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 2017:EN-1262

19 MCPDs, 2-MCPDs and Glycidyl esters Table 10: List of specific requirements for MCPDs and Glycidyl esters data collection SSD Data Parameter code (R.06) Analytical method text (R.11) MCPD and Glycidyl esters Please see reporting rules in Annex VIII (column f). For the analysis of 3- and 2-MCPD esters and Glycidyl esters it is mandatory to clarify whether the samples have been analysed with one of the three methods validated by the American Oil Chemists Society (AOCS) in October 2013 (AOCS, 2013) (or a variant of them), or a different method. In case of the three methods, the appropriate code from Table 11: has to be reported; otherwise a reference to the different method has to be provided. The same applies in the case of 3- and 2-MCPD total referring to the ester part of the sum. Percentage of fat in the original sample (R.24) It is recommended to always report the percentage of fat in the original sample (regardless of whether the result value is expressed on a whole weight, fat weight or dry matter basis). The recommended methods for ester analysis are the three methods validated by American Oil Chemists Society (AOCS) in October Table 11: List of codes of the recommended analysis techniques for analysing esters Code AOCS1 AOCS2 AOCS3 Applied analysis step AOCS validated methods for MCPD and Glycidyl esters AOCS Official Method Cd 29a 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 2017:EN-1262

20 Mycotoxins Table 12: List of specific requirements for Mycotoxins data collection SSD Data EFSA product code (S.12) Parameter code (R.06) 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) 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 young children. Please see reporting rules in Annex VIII (column f). 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 401/2006) 23. 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). 23 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 2017:EN-1262

21 Arsenic and derivatives Table 13: List of specific requirements for Arsenic and derivatives data collection SSD Data Product full text description (S.14) Product treatment (S.17) Ingredient (S.20) Product comment (S.21) Parameter code (R.06) Arsenic and derivatives Product full text description is mandatory to report for ALL contaminants. If data reported: On seaweed, it is strongly recommended to provide information on seaweed to identify the presence of the alga Hijiki. For rice, it is strongly recommended to provide information about the type of the rice selecting one of the categories below: - Paddy rice (rice grain) is rice (species Oryza sativa L.), which has retained its husk after threshing. - Husked rice (brown rice or cargo rice) is paddy rice from which the husk only has been removed. The process of husking and handling may result in some loss of bran. - Polished rice (milled rice or white rice) is husked rice from which all or [part of] the bran and germ have been removed by milling. 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. If data are reported on rice, it is recommended to report the growth conditions of the plant: - Flooded condition: the paddy field, where rice is grown is filled or covered with water during growth. - Aerobic condition: the soil in a paddy field, where rice is grown is more aerobic than flooded condition. (Aerobic rice technology is a production system in which rice is grown in well-drained, non-puddled, and non-saturated soils.) - Intermittent ponding: a variety of possible water management practices in which a paddy field is alternately in flooded and aerobic/non-flooded condition. - Production under irrigation. Please see reporting rules in Annex VIII (column f) EFSA Supporting publication 2017:EN-1262