Revision of specific requirements for chemical contaminants and food additives for reporting data in SSD2

Transcription

1 EXTERNAL SCIENTIFIC REPORT APPROVED: 02 December 2015 PUBLISHED: 17 December 2015 Revision of specific requirements for chemical and food additives for reporting data in SSD2 National Sanitary Veterinary and for Food Safety Authority of Romania (ANSVSA) Abstract The Standard Sample Description ver. 2 (SSD2) for food and feed will be the future 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 SSD2 contains nine mandatory data elements (fields) which are relevant for all data domains and enable a unique description of each sample. The purpose of this document is to describe in detail the individual data elements that are included in the EFSA SSD2 data model to be used for the XML/Excel data transmission through the DCF (with emphasis on the mandatory ones for Chemical Contaminants/Food Additives data collection) and mainly to adapt existing specific requirements for guiding any future submission of occurrence data according to the new Standard Data Model. ANSVSA, 2015 Key words: SSD2, Chemical contaminant,, specific requirement. Question number: EFSA-Q Correspondence: data.collection@efsa.europa.eu EFSA Supporting publication 2015

2 Specific requirements for chemical and food additives in SSD2 Disclaimer: The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors. Acknowledgements: Romania wishes to thank the members of the participating countries Portugal, Denmark and Poland, to project OC/EFSA/DCM/2013/05, for the preparatory work on this scientific output and EFSA staff for the support provided to this output. 2 EFSA Supporting publication 2015:EN-921

3 Specific requirements for chemical and food additives in SSD2 Summary Data collection is an important task of the European Food Safety Authority (EFSA) and a fundamental component of risk assessment (Articles 22 and 23 of Regulation (EC) No 178/ ). EFSA receives a large volume of data from Member States (MSs) in support of its risk assessments. The EFSA is assigned the tasks of examining the data collected and preparing the reports on the results obtained from the monitoring of chemical and food additives. For the reporting of the annual data, EFSA currently provides a Data Collection Framework (DCF) that allows data providers to submit data in extensible markup language (XML)/Microsoft Office Excel formats through a web interface or a web service, respectively. Data model is provided to the reporting countries describing the format and the content requested for submitting data through the DCF. To support reporting countries in data submission using XML/Excel data transfer, specific guidelines are given in this report covering the reporting data. The objective of this document is to explain in detail the individual data elements that are included in the EFSA SSD2 data model to be used for the XML/Excel data transmission through the DCF. In particular the data elements to be reported are explained, including information about the data type, a reference to the list of allowed terms and any additional requirement that may apply. 1 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 EFSA Supporting publication 2015:EN-921 by the author(s) in the context of a contract between the European Food Safety Authority and the author, awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the author.

4 Specific requirements for chemical and food additives in SSD2 Table of contents Abstract... 1 Summary... 3 Background as provided by EFSA... 5 Introduction , recommended, optional and dependent data elements in the SSD Requirements that apply to all data collections of chemical and food additives Requirements that apply to specific data collections of chemical 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 Bisphenol A Perchlorates Conclusions References Appendices Acronyms EFSA Supporting publication 2015:EN-921

5 Specific requirements for chemical and food additives in SSD2 Background as provided by EFSA In the framework of Articles 23 and 33 of Regulation (EC) No. 178/2002 2, 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 in food and feed. In particular, mandate M describes the scope of the continuous annual data collection of in food and feed 4. In addition, when it is necessary, ad hoc calls for data are issued on the EFSA website. Introduction The Standard Sample Description (SSD2) defines nine mandatory data elements (fields) to enable a unique description of an analytical sample from any specific chemical substance data collection. For some (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 4 of Standard Sample Description (SSD2) and in the Guidance on Data Exchange (GDE2) (EFSA Journal 2014;12(12):3945, 173 pp. doi: /j.efsa ) which remain valid. Any data submitted to EFSA is uploaded into EFSA s chemical 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 (GDE2) and as a part of this process DCF checks the presence of the mandatory data elements. Data with missing information, mandatory for all chemical, is rejected automatically by DCF. Data elements, mandatory only for specific (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., recommended, optional and dependent data elements in the SSD2 The SSD2 contains 94 data elements (e.g. Sample taken identification code, Year of sampling, Country of sampling etc.). Of these, nine are defined as mandatory, the other could be recommended, optional or dependent. : information that is essential for exposure assessment (e.g. Sample taken identification code, Year of sampling, Country of sampling, Type of matrix, Coded description of the matrix of the sample taken, Year of analysis, Type of parameter, Coded description of the parameter, Result identification code or Text description of the matrix analysed). If data are missing from a mandatory data element, the transmitted data file from a Member State 2 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 M EFSA Supporting publication 2015:EN-921

6 Specific requirements for chemical and food additives in SSD2 data provider to EFSA will be automatically rejected. Some data elements can be made mandatory also by the business rules in special circumstances, only when some values are present in related data elements. Additional information on this aspect is provided in the business rules section in the GDE2. : information that is useful for an exposure assessment (e.g. Result value recovery rate, Result value uncertainty, Accreditation procedure for the analytical method, Additional information on the result, etc.). 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. Optional: Optional data elements are not mandatory, but a value/code can be returned (on a voluntarily basis) at the discretion of the reporting country if the information is considered relevant. Dependent: For the specific domain, the data element shall be considered as mandatory under certain conditions (specified in table 1)., recommended, optional and dependent status of data element or the addition of a new data element applies to data transmission of all chemical and food additives is given in Table 1. Chapter 1.1 describes requirements (mandatory, recommended, optional or dependent) that apply to all chemical and food additives, while chapter 1.2 describes requirements that apply only to certain and food additives in particular. Table 1: Standard Sample Description (SSD2) data elements and their applicability to transmission of data on the occurrence of and food additives. Local organisation identification code (A.01) Local organisation country (A.02) Local organisation additional information (A.03) Sampling programme identification code (B.01) Status of data Element: / Status: Valid from Applicable to Programme legal reference (B.02) 2015 Sampling strategy (B.03) 2010 Programme type (B.04) 2010 Sampling method (B.05) 2010 Sampler (B.06) 2015 Condition/comment For Bisphenol report "Not specified" Report "Not specified" For Bisphenol report "Not specified" Report "Not specified" For Bisphenol report "Not specified" Report "Not specified" 6 EFSA Supporting publication 2015:EN-921

7 Specific requirements for chemical and food additives in SSD Sampling point (B.07) 2010 Additional sampling program information (B.08) Sampling event identification code (C.01) Sampling unit type (C.02) 2015 Sampling unit size (C.03) Sampling unit size unit (C.04) Dependent 2015 Other sampling unit identifications (C.05) Additional sampling event information (C.06) Sample taken identification code (D.01) Reporting country (D.02) Country of sampling (D.03) 2010 Area of sampling (D.04) 2015 Reporting year (D.05) 2015 Year of sampling (D.06) Month of sampling (D.07) Day of sampling (D.08) For Bisphenol report "Not specified" When C.03 is reported EU if the data reported represent the entire EU market; otherwise, report the country to which the usage data apply (COUNTRY catalogue of the SSD2) for Acrylamide 7 EFSA Supporting publication 2015:EN-921

8 Specific requirements for chemical and food additives in SSD2 Sample taken size (D.09) Sample taken size unit (D.10) Additional Sample taken information (D.11) 2015 Dependent 2015 Type of matrix (E.01) 2015 Coded description of the matrix of the sample taken (E.02) 2015 when D.09 is reported The production method facet is mandatory for Acrylamide; The packaging facet is mandatory for Bisphenol A and recommended for PAHs; The ingredients facet is recommended for Arsenic, Acrylamide. It is mandatory for Arsenic in rice based products For Bisphenol A the simulant codes must be reported Attribute Process (F28): It is mandatory to clearly indicate if the original sample is treated or not for all data domains, especially if it is a dehydrated product (select:"drying (dehydration)", A07KG). Attribute F04: Ingredient. Recommendation for reporting composition should apply to all compound products, and in particular, it is important to specify composition for: compound products for infants and small children, including readymade meals, diet supplements, herb mixes and spice mixes. In case of diet supplements, it is necessary to qualify the diet supplement using the most precise FoodEx2 descriptor this group of foodstuffs. 8 EFSA Supporting publication 2015:EN-921

9 Specific requirements for chemical and food additives in SSD2 Text description of the matrix of the sample taken (E.03) Country of origin of the sample taken (E.04) Area of origin of the sample taken (E.05) Area of origin for fisheries or aquaculture activities code of the sample taken (E.06) Area of origin for fisheries or aquaculture activities text of the sample taken (E.07) Country of processing of the sample taken (E.08) Area of processing of the sample taken (E.09) Additional information on the matrix sampled (E.10) Sample analysed identification code (F.01) Sample analysis reference time (F.02) Dependent Dependent Year of analysis (F.03) 2010 Month of analysis (F.04) Day of analysis (F.05) All chemical Attribute F18: Packaging format, F19: Packaging material - recommended for all foodstuffs for the purpose of characterizing product packaging. The classification (Food additive code) based on the Regulation 1333/2008 of the European Parliament and Council of 16 December 2008 on food additives. Classification is partly included as implicit facets of the FoodEx2 code and otherwise can be picked from the Attribute F33, Foodadditive-legistative-class. See comment from Table 20 Brominated Flame Retardants (BFRs) BFRs - only when the specific information on E.06 is not available See comment from Table 20 By default same as D EFSA Supporting publication 2015:EN-921

10 Specific requirements for chemical and food additives in SSD2 Additional information on the sample analysed (F.06) Coded description of the analysed matrix (G.01) Text description of the matrix analysed (G.02) Additional information on the analysed matrix (G.03) Packaging facetmandatory for bisphenol A (BPA); recommended for Polycyclic aromatic hydrocarbons(pahs) See E.02 Sample analysed portion sequence (H.01) Sample analysed portion size (H.02) Sample analysed portion size unit (H.03) Additional information on the sample analysed portion (H.04) Laboratory identification code (J.01) Status of data Element: / Status: Valid from Applicable to Dependent Optional 2013 Laboratory accreditation (J.02) 2010 Laboratory country (J.03) Additional information on the laboratory (J.04) Type of parameter (K.01) 2010 Coded description of the parameter (K.02) 2010 Parameter text (K.03) Dependent 2010 Analytical method identification 2015 (L.01) Condition/comment if H.02 is filled Only if the parameter code (K.02) is "Not in list" (a) 10 EFSA Supporting publication 2015:EN-921

11 Specific requirements for chemical and food additives in SSD2 Analytical method reference code (L.02) Analytical method type (L.03) Analytical method code (L.04) 2013 Analytical method text (L.05) Dependent 2013 Additional information on the analytical method (L.06) Result identification code (M.01) 2010 Accreditation procedure for the analytical method (M.02) 2010 Result unit (M.03) 2010 Result LOD (M.04) Dependent 2010 Result LOQ (M.05) 2015 Result lower limit of the working range (M.06) Result upper limit of the working range (M.07) CC alpha (M.08) CC beta (M.09) Result value (M.10) Dependent 2010 Result value recovery rate (M.11) Result value corrected for recovery (M.12) Expression of result percentage (M.13) Dependent 2015 * For 3-MCPD ester or if the analytical method code (L.04) is "Classification not possible (b) Only if L.04 is listed Not possible If the Type of result (M.16) is below "Limit of Detection (<LOD)" If the Type of result (M.16) is "Numerical value" It is particularly important for mycotoxins *% moisture is mandatory for all only, if results are expressed on 'dry weight'; 88% dry matter or 40% dry 11 EFSA Supporting publication 2015:EN-921

12 Specific requirements for chemical and food additives in SSD2 Expression of result type (M.14) 2013 Result qualitative value (M.15) Type of result (M.16) Result value uncertainty (M.17) `Result reference identification (M.19) Additional information on the result (M.20) Limit for the result evaluation (N.01) Limit for the result evaluation (High limit) (N.02) Type of limit for the result evaluation (N.03) matter basis. For mineral oils and mycotoxins it is recommended also for whole weight basis. *% fat is mandatory for all only, if the results are expressed in 'fat weight' basis. For BFRs, Dioxins and PCBs, 3- MCPD esters and ALL chemical ; it is recommended even for whole weight basis if result expressed in moist% or fat% 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. For Bisphenol A report for all records "BPA migration data" See comment from Table 20 See comment from Table EFSA Supporting publication 2015:EN-921

13 Specific requirements for chemical and food additives in SSD2 Evaluation of the result (N.04) Action Taken (N.05) Additional information on the evaluation (N.06) 2015 (a): 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. (b): 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. See comment from Table 20 See comment from Table 20 See comment from Table Requirements that apply to all data collections of chemical and food additives Table 2 describes requirements which apply to occurrence data pertaining to and food additives submitted from Member State data providers to EFSA, irrespective of whether the contaminant is listed in this document. Table 2: Description of the mandatory, recommended, optional and dependent requirements for ALL data collections Local organisation identification code (A.01) Unique identification of the local or regional or national organisation (Competent Authority or company affiliate) requesting the analysis. Local organisation country (A.02)* Country where the local organisation is placed. (ISO alpha-2) 13 EFSA Supporting publication 2015:EN-921

14 Specific requirements for chemical and food additives in SSD2 Local organisation additional information (A.03) Sampling programme identification code (B.01) Additional specific information and comments on the local organisation depending on specific requirements of the different data collection domains. Unique identification code of the programme or project for which the sampling unit was taken. Programme legal reference (B.02)* Reference to the legislation for the programme defined by programme code. Reference to the legislation on what to sample, how to evaluate the sample etc. Sampling strategy (B.03)* Programme type (B.04)* Sampling method (B.05)* Sampler (B.06)* Sampling point (B.07)* Sampling strategy describe how the sample was selected (ref. EUROSTAT - Typology of sampling strategy performed in the programme or project identified by programme code (e.g. objective and selective sampling)). Indicate the type of programme for which the samples have been collected (National, EU programme, Total diet study, Control and eradication programme) Reference to the method for sampling (e.g. EU legislation) Define which organization (private or public) is performing the sample. Point, in the food chain, where the sample was taken. (See Doc. ESTAT/F5/ES/155 Data dictionary of activities of the establishments ). Additional sampling program information (B.08) Additional specific information and comments on the sampling programme depending on specific requirements of the different data collection domains such as if the programme is used for the verification of the Salmonella reduction target, number of animal under the control program, total number of samples tested, etc. Sampling event identification code (C.01) Sampling unit type (C.02)* Unique identification of the sampling event. The entity representing the sampling unit extracted at certain time from the sampled population, which chemical or microbiological properties are the target of the sampling. Define the type of sampling unit taken in this event: a batch, an animal, a flock, a herd, etc. Sampling unit size (C.03) It contains the size/amount of the sampling unit. Sampling unit size unit (C.04)* It contains the Unit in which the sampling unit size is expressed. Other sampling unit identifications (C.05) Additional sampling event information (C.06) Sample taken identification code (D.01) Additional identification codes for the sampling unit, at a more detailed level than the sampling event ID e.g. herd code or animal ear tag number. Additional information on the sampling event depending on specific requirements of the different data collection domains such as status of the holding, the vaccination status, the date and country of slaughtering, etc. Identification code of the sample taken Reporting country (D.02)* Country of sampling (D.03)* Area of sampling (D.04)* The country the reported data refer to (ISO alpha-2). Country where the sample was taken for laboratory testing (ISO alpha-2). Area where the sample was collected (Nomenclature of territorial units for statistics - NUTS - coding system valid only for EEA and Switzerland). Reporting year (D.05) The year the reported data refer to EFSA Supporting publication 2015:EN-921

15 Specific requirements for chemical and food additives in SSD2 Year of sampling (D.06) Year of sampling. In case the sampling has been performed over a period of time the start date (as year) of sampling should be reported. Month of sampling (D.07) Month of sampling. In case the sampling has been performed over a period of time the start date (as month) of sampling should be reported Day of sampling (D.08) Day of sampling. In case the sampling has been performed over a period of time the start date (as day) of sampling should be reported. Sample taken size (D.09) Total size/amount of the sample. Sample taken size unit (D.10)* Unit in which the size/amount of the sample is expressed. Additional Sample taken information (D.11) Additional information on the sampling taken depending on specific requirements of the different data collection domains (e.g. day of arrival in the lab). Type of matrix (E.01)* Type of sample taken (e.g. food, food stimulants, animal, feed, environment; food contact material), identifying the sub-domain of the matrix catalogue to be used. Coded description of the matrix of the sample taken (E.02)* Text description of the matrix of the sample taken (E.03) Country of origin of the sample taken (E.04)* Description of the sample taken characteristics using the FoodEx2 catalogue Description of the sample taken characteristics using free text This element will be assumed to have the same value as "anmattext" (G.02), unless otherwise populated Country of origin of the sample taken (ISO alpha-2 country code). Area of origin of the sample taken (E.05)* Area of origin for fisheries or aquaculture activities code of the sample taken (E.06) Area of origin for fisheries or aquaculture activities text of the sample taken (E.07) Country of processing of the sample taken (E.08) Area of processing of the sample taken (E.09)* Additional information on the matrix sampled (E.10) Sample analysed identification code (F.01) Area of origin of the sample taken (Nomenclature of territorial units for statistics - NUTS - coding system valid only for EEA and Switzerland). Fisheries or aquaculture area specifying the origin of the sample (FAO Fisheries areas). Fisheries or aquaculture area specified in free text. Country where the food was processed (ISO alpha-2). Area of product processing (Nomenclature of territorial units for statistics - NUTS coding system valid only for EEA and Switzerland). Additional specific information and comments on the matrix sampled, depending on specific requirements of the different data collection domains. Original description of the sample from the national database can be copied here. It should be avoided to repeat just the FoodEx2 description. Also collection of product labelling as protected designations of origin, protected geographical indications and traditional specialities guaranteed could be recommended. Identification code of the analysed sample, by default the same as the sampid 15 EFSA Supporting publication 2015:EN-921

16 Specific requirements for chemical and food additives in SSD2 Sample analysis reference time (F.02)* Year of analysis (F.03) Month of analysis (F.04) Day of analysis (F.05) Additional information on the sample analysed (F.06) Coded description of the analysed matrix (G.01)* Text description of the matrix analysed (G.02) Additional information on the analysed matrix (G.03) Sample analysed portion sequence (H.01) Sample analysed portion size (H.02) Sample analysed portion size unit (H.03)* Additional information on the sample analysed portion (H.04) Define the time at which the sample was analysed e.g. analysed at arrival to the laboratory, analysed at the end of shelf-life (according to European legislation on microbiological criteria Reg. 2073/2005). Year when the analysis was completed. Month when the analysis was completed. Day when the analysis was completed. Additional specific information and comments on the sample analysed depending on specific requirements of the different data collection domains. Encoding of the matrix analysed characteristics using the FoodEx2 catalogue. By default this element has the same value as sampmatcode Description of the matrix analysed characteristics using free text. This element will be assumed to have the same value as "sampmattext" (E.03), unless otherwise populated. See comment of E.03 Additional specific information and comments on the matrix analysed depending on specific requirements of the different data collection domains. Sequence number (e.g. 1, 2, 3) reflecting the sample analysed portion actually under analysis. The default value is 1. Size / amount of the sample analysed portion, i.e. amount of sample weight for analysis (weight of test portion). Unit in which the size of the sample analysed portion is expressed. Additional information and comments on the sample analysed portion depending on specific requirements of the different data collection domains Laboratory identification code (J.01) Laboratory accreditation (J.02)* Laboratory country (J.03)* Additional information on the laboratory (J.04) Type of parameter (K.01)* Identification code of the laboratory (National laboratory code if available). This code should be nationally unique and consistent through all data domain transmissions The accreditation status of the laboratory and its reference procedure. Country where the laboratory is located (ISO alpha-2). Additional specific information and comments on the laboratory (e.g. total number of isolates available in the laboratory) depending on specific requirements of the different data collection domains. Define if the parameter reported is an individual residue/ analyte, a summed residue definition or part of a summed residue definition. Coded description of the parameter (K.02)* Encoding of the parameter/ analyte according to the PARAM catalogue. Parameter text (K.03) Analytical method identification (L.01) Analytical method reference code (L.02)* Analytical method type (L.03)* Description of the parameter/ analyte using free text. Identifier for the method used in the laboratory. When validated methods are used, the official reference code should be provided. Type of analytical method used 16 EFSA Supporting publication 2015:EN-921

17 Specific requirements for chemical and food additives in SSD2 Analytical method code (L.04)* Encoding of the method or instrument used from the ANLYMD catalogue. Analytical method text (L.05) Description of the method or instrument using free text, particularly if other / Classification not possible were reported for Analytical method code. Additional information on the analytical method (L.06) Additional specific information and comments on the analytical method depending on specific requirements of the different data collection domains such as disk concentration and diameter for antimicrobial resistance diffusion method, method sensitivity and method specificity, migration time, migration temperature, etc. Result identification code (M.01) Accreditation procedure for the analytical method (M.02)* Result unit (M.03)* Result LOD (M.04) Result LOQ (M.05) Result lower limit of the working range (M.06) Result upper limit of the working range (M.07) CC alpha (M.08) CC beta (M.09) Result value (M.10) Result value recovery rate (M.11) Result value corrected for recovery (M.12)* Expression of result percentage (M.13) Expression of result type (M.14)* Result qualitative value (M.15)* Type of result (M.16)* Identification code of an analytical result (a row of the data table) in the transmitted file. The result identification code must be maintained at organisation level and it will be used in further updated/deletion operation from the senders The accreditation status of the analytical method used and its reference procedure. Unit of measurement for the values reported in Result LOD, Result LOQ, ResLLWR, ResULWR, CC alpha, CC beta, Result value, Result value uncertainty standard deviation, Result value uncertainty, Limit for the result evaluation and Limit for the result evaluation (High limit). Limit of detection expressed in the unit specified by the element Result unit. Limit of quantification expressed in the unit specified by the element Result unit. Lower limit of the working range expressed in the unit specified by the element Result unit. Upper limit of the working range expressed in the unit specified by the element Result unit. CC alpha value (decision limit) expressed in the unit specified by the element Result unit. CC beta value (detection capability) expressed in the unit specified by the element Result unit. The result of the analytical measure expressed in the unit specified by the element Result unit. Recovery value associated with the concentration measurement expressed as a percentage (%). i.e. report 100 for 100 %. Define if the result value has been corrected for recovery This compound field can be used to report the percentage of a measured specific matrix component (e.g. fat, alcohol, moisture) used as reference to express the analytical result (e.g. on fat basis, on alcohol basis and on dry weight basis). If % dry mass or fat content has been introduced, information on the analytical method used for determining dry mass or fat content should be stated Code to describe how the result has been expressed: whole weight, fat weight, dry weight, etc. This field should be completed only if the result value is qualitative e.g. positive/ present or negative/ absent. In this case the element Result value should be left blank. Indicate the type of result, whether it could be quantified/determined or not EFSA Supporting publication 2015:EN-921

18 Specific requirements for chemical and food additives in SSD2 Result value uncertainty (M.17) Result reference identification (M.19) Additional information on the result (M.20) Indicate the expanded uncertainty value (usually 95% confidence interval) associated with the measurement expressed in the unit reported in the field Result unit. When the result is a complex structure, the identification code to the external structure is stored here (e.g. molecular typing images). Additional specific information and comments on the result section depending on specific requirements of the different data collection domains. 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. Report whether the product has been prepared before the analysis Reporting of information whether the result refers to the reconstituted ( analyzed as consumed ) or sold ( analyzed as purchased ) form should be recommended in case of products to be prepared (reconstitution with water or milk) by consumer, particularly infant formulae, follow-on formulae and cereal based foodstuffs for infants and small children. An appropriate dilution factor should be included for products analyzed as consumed. Limit for the result evaluation (N.01) Report the reference or legal limit, limit or cut-off value for the parameter/analyte for the relevant matrix or the lower level of three class evaluation limit analyte. It is expressed in the unit specified by the element Result unit. Limit for the result evaluation (High limit) (N.02) Type of limit for the result evaluation (N.03)* Evaluation of the result (N.04)* Action Taken (N.05)* Report the higher legal limit of the analyte for the three-class evaluation limit analyte. It is expressed in the unit specified by the element Result unit. Type of legal limit used to evaluate the result. ML, MRPL, MRL, action limit, cut-off value etc. Evaluation of the result. If the result exceeds a limit specified above or contains the evaluation on Sampling Event, Sample Taken, or Sample Analysed as indicated by evallowlimit (N.01). Describe any follow-up actions taken as a result higher than the legal limit. Additional information on the evaluation (N.06) Clarification note on Result value (M.10), Result value recovery rate (M.11) and Result value corrected for recovery (M.12) Additional specific information and comments on the evaluation section depending on specific requirements of the different data collection domains. The analytical results reported in the data element Result value (M.10) 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 rate (M.11)) to improve the quality of the assessment. * Catalogues in SSD EFSA Supporting publication 2015:EN-921

19 Specific requirements for chemical and food additives in SSD Requirements that apply to specific data collections of chemical Tables 3 to 20 describe requirements which apply to occurrence data pertaining to specific 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. Status of Data Element (/ Brominated Flame Retardants Area of origin for fisheries or aquaculture activities code and text (E.06 and E.07) 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 (E.06) 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 (E.07). Coded description of the parameter (K.02) Expression of result percentage (M.13) 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) Dioxins and PCBs Table 4: List of specific requirements Dioxins and DL-PCBs, non-dioxin-like PCBs data collection Dioxins and DL-PCBs, non-dioxin-like PCBs Coded description of the matrix of the sample taken (E.02) Additional information on the matrix sampled (E.10) Status of Data Element (/ The appropriate descriptor field E.02 should specify species of he tested fish, and the descriptor field G.01 should state the part of fish body tested (ex: liver, muscle tissue, etc.) Attribute F28: Process The processing which the fish underwent should be stated using FoodEx2. In case of herring, sprats, salmon and trout derived from the Baltic Sea required should be supplying of information on length of fish body, fish weight and, if possible, fish age. In case of Baltic salmon and trout required should be information as to whether the fish had been trimmed. Ultimately the trimming process should be included into FoodEx2 terminology, attribute F28: Process. is entry of date of fish catch EFSA Supporting publication 2015:EN-921

20 Specific requirements for chemical and food additives in SSD2 Coded description on the analysed matrix (G.01) Additional information on the analysed matrix (G.03) The appropriate descriptor field E.02 should specify species of the tested fish, and the descriptor in field G.01 should state the part of fish body tested (e.g. liver, muscle tissue, etc.). In case the sample is reconstituted before analysis, e.g. food products for young population, 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)". Coded description of the parameter (K.02) 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. Expression of result percentage (M.13) 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. Additional information on the result (M.20) 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) Mineral Oils Table 5: List of specific requirements for Mineral Oils data collection Additional information on the analysed matrix (G.03) Expression of result percentage (M.13) Status of Data Element (/ Mineral Oils The data providers are 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 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.) Additional information on the result (M.20) 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 20 EFSA Supporting publication 2015:EN-921

21 Specific requirements for chemical and food additives in SSD Acrylamide Table 6: List of specific requirements for Acrylamide data collection Acrylamide Status of Data Element (/ ) Month of sampling (D.07) 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.) Coded description of the matrix of the sample taken (E.02) (Ingredients) 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 $. Country of processing of the sample taken (E.08) It is recommended to provide the country where the food was processed (ISO alpha-2). Additional information on the matrix sampled (E.10) (Brand name, Manufacturer) Text description of the matrix analysed (G.02) Additional information on the analysed matrix (G.03) In addition to Coded description of the analysed matrix (G.01), 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 6 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 recommended to provide the product brand name. It is recommended to provide the company/ manufacturer of the product. It is strongly recommended to classify the food samples at the most detailed hierarchical level available (food sub-categories codes). 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) 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.) (Clarify whether anmatinfo.com should be used for 2010/307-codes). 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. 6 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 2015:EN-921

22 Specific requirements for chemical and food additives in SSD2 Acrylamide Result LOQ (M.05) Result value uncertainty, Standard deviation (M.17, M.18) Action taken, Additional information on the result (N.05, M.20) Additional information on the evaluation (N.06) Status of Data Element (/ ) 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)". In addition to E.02 sampmatcode/g.01 anmatcode, 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) 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 (M.10) and Type of result (M.16). (Commission Recommendation 2007/331, Annex II). 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). If the indicative value stated in Commission Recommendation No 2013/647/EU on investigations into the level of acrylamide in food is exceeded, information as to whether the appropriate recommended investigation has been conducted in the foodstuff undertaking. It should be stated if the principles of the acrylamide toolbox had been applied in the foodstuff undertaking. Important The official deadline for Acrylamide data submission to EFSA is by 1 June each year according to the Commission Recommendation (2010/307/EC) 22 EFSA Supporting publication 2015:EN-921

23 Specific requirements for chemical and food additives in SSD2 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 Additional information on the matrix sampled (E.10) of the SSD2 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 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 23 EFSA Supporting publication 2015:EN-921