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Document 52023XC0609(02)
Communication from the Commission concerning Part B of the Annex to Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance) 2023/C 202/03
Communication from the Commission concerning Part B of the Annex to Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance) 2023/C 202/03
Communication from the Commission concerning Part B of the Annex to Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance) 2023/C 202/03
C/2023/3552
OJ C 202, 9.6.2023, p. 14–24
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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9.6.2023 |
EN |
Official Journal of the European Union |
C 202/14 |
Communication from the Commission concerning Part B of the Annex to Commission Regulation (EU) No 283/2013 setting out the data requirements for active substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
(Text with EEA relevance)
(2023/C 202/03)
This guidance has been developed in consultation with the Member States. It does not intend to produce any legally-binding effects and, by its nature, cannot prejudice any measure taken by a Member State in the implementation of Regulation (EC) No 1107/2009, nor any case law developed with regard to this provision. Only the Court of Justice is empowered to authoritatively interpret and apply Union law.
The present Commission Communication fulfils Point 6 of the Introduction of the Annex to Regulation (EU) 283/2013 that provides that, for purposes of information and of harmonisation, the list of test methods and guidance documents relevant to the implementation of this Regulation must be published in the Official Journal of the European Union. The list below represents this list for Part B of the Annex to Regulation (EU) 283/2013, as amended by Commission Regulation (EU) 2022/1439 (1), and will be updated regularly.
Where provisions of Part B of the Annex to Regulation (EU) No 283/2013 require generation of data based on requirements laid down in Part A of the Annex to Regulation (EU) No 283/2013, the relevant test methods and guidance are listed in the Commission Communication relevant to the implementation of Part A of the Annex to Regulation (EU) No 283/2013 (i.e. regarding chemical active substances).
Listing of a document for a section means that it is relevant for all the sub-sections. In case there is no document listed for a section, no agreed test method or guidance document is currently available. In these cases, potential applicants should discuss proposals during the pre-submission meeting with the Rapporteur Member State and the European Food Safety Authority (EFSA), e.g. based on draft test methods.
Test methods
Only test methods that have been validated (i.e. ring-tested by the OECD or equivalent international organisations) are listed. Test methods only described in scientific publications have not been included.
The listing of a test method should be read as referring to the most updated version of that test method available at the time of the initiation of the study.
For active substances that are micro-organisms, ad-hoc test protocols may be needed to address some data requirements. During the pre-submission phase (2), applicants, the Rapporteur Member State, and EFSA may discuss this kind of ad-hoc test protocols, in particular if test protocols listed in the Commission Communication relevant to the implementation of Part A of the Annex to Regulation (EU) No 283/2013 can be used as surrogates or whether they can be adapted to be more suitable for active substances that are micro-organisms.
In view of minimising testing on vertebrate animals, tests already carried out based on older test methods should be considered as part of the risk assessment, as provided for in Article 62 of Regulation (EC) No 1107/2009. However, during the pre-submission meeting, applicants, the Rapporteur Member State and EFSA may consider whether new test according to newer test methods are needed, if scientifically justified.
In all cases, in accordance with Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (3), Regulation (EC) No 1107/2009 (Recitals 11 and 40, Articles 8.1(d), 18(b), 33.3(c) and 62.1) and Commission Regulation (EU) No 283/2013 (4), unnecessary animal testing must be avoided. More specifically, Article 62 of Regulation (EC) No 1107/2009 provides that testing on vertebrate animals for the purposes of the approval of active substances for plant protection products shall be undertaken only where no other methods are available. Alternative methods include in-vitro testing, in-silico methods or other approaches such as read-across, as described for instance in the EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches and the EURL ECVAM Status Report on Non-animal Methods in Science and Regulation (5). Furthermore, availability of guidance documents on non-animal testing and validated and reliable in–vitro study protocols should be considered as a valid scientific justification when considering point 1.5 of the Introduction of the Annex to Regulation (EU) No 283/2013.
If several test methods are available to fulfil a data requirement, the order of test methods listed indicates a preference in case a new test is needed. The order prioritises methods where no or fewer test animals are needed and/or this method is associated with less severe suffering of the test animals. However, during the pre-submission meeting, upon advice by EFSA and the Rapporteur Member State, the order of priority can be changed when scientifically justified (e.g. due to limitations of the applicability domain of some methods) in order to ensure the scientific quality of the assessment.
Guidance documents
Guidance documents qualify to be listed when they:
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have been endorsed by the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) before the publication of this Communication, |
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have been developed under the auspices of an official body (e.g. EFSA, the Commission, national authorities) with the aim to address a certain area of risk assessment or procedural issues, and were consulted with relevant stakeholders, or |
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have been endorsed by an intergovernmental organisation (such as OECD, FAO, WHO, or EPPO) where the Member States take part in the endorsement process. |
The following types of guidance documents have been considered for listing:
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Technical guidance documents, including guidance documents that are of horizontal nature that are relevant for several or all sections of the data requirements, including implementation of point 1.5 of the Introduction of the Annex to Regulation (EU) No 283/2013; |
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Administrative/procedural guidance documents if they are relevant for the implementation of the data requirements; |
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Models or calculation tools, if they are relevant for the data requirements and can be linked to or are supportive to a guidance document; |
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Scientific Opinions of the EFSA Panels and guidance documents from the interzonal Steering Committee relevant for all the Member States have been listed following a consideration on a case by case basis, if they are relevant for the implementation of specific data requirements. |
Documents such as zonal guidance documents, EFSA statements, peer reviewed publications, technical reports, scientific reports, strategies are generally not included in the list below, except for some which were subject to a public consultation.
The listing of a guidance document should be read as referring to the most updated version of that guidance document available at the time of the initiation of the study.
As regards the EPPO standards series concerning the efficacy evaluation of plant protection products, the most relevant standards are indicated in the list below. However, the list must be considered not exhaustive since the EPPO global database is updated regularly and other standards may be needed on a case-by-case approach. Consequently, the EPPO global database is also included in the table below.
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Reference to Part B of the Annex to Regulation (EU) No 283/2013 |
Test methods (6) |
Guidance documents (7) |
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General test methods and guidance documents |
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EFSA Guidance on submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA Journal 2011;9(2):2092) |
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General test methods and guidance documents |
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EFSA Guidance on the use of the weight of evidence approach in scientific assessments (EFSA Journal 2017;15(8):4971) |
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General test methods and guidance documents |
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EU Guidance document on the assessment of new isolates of baculovirus species already included in Annex I of Council Directive 91/414/EEC (SANCO/0253/2008) |
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General test methods and guidance documents |
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EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) |
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General test methods and guidance documents |
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OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) |
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General test methods and guidance documents |
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OECD Guidance Document for the Regulatory Framework for the Microorganism Group: Bacteriophages Series on Pesticides No. 108 |
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EU Guidance Document for the assessment of the equivalence of technical grade active ingredients for identical microbial strains or isolates approved under Regulation (EC) No 1107/2009 (SANCO/12823/2012) |
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OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 |
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EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) |
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EU Guidance document on the risk assessment of metabolites produced by microorganisms used as plant protection active substances (SANCO/2020/12258) |
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EFSA Statement on the requirements for whole genome sequence analysis of microorganisms intentionally used in the food chain (EFSA Journal 2021;19(7):6506) |
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EU Guidance document on the approval and low-risk criteria linked to ‘antimicrobial resistance’ applicable to microorganisms used for plant protection in accordance with Regulation (EC) No 1107/2009 (SANTE/2020/12260) |
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EPPO PP1/248 Harmonized classification and coding of the uses of plant protection products (8) |
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EPPO Global database (9) |
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EPPO PP1/248 Harmonized classification and coding of the uses of plant protection product (10) |
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EPPO PP1/213: Resistance risk analysis |
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EFSA Guidance on submission of scientific peer-reviewed open literature for the approval of pesticide active substances under Regulation (EC) No 1107/2009 (EFSA Journal 2011;9(2):2092 - including appendix (11)) |
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EU Guidance document: Technical Active Substance and Plant protection products: Guidance for generating and reporting methods of analysis in support of pre- and post-registration data requirements for Annex (Section 4) of Regulation (EU) No 283/2013 and Annex (Section 5) of Regulation (EU) No 284/2013 (SANCO/3030/99) |
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OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No. 65 |
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Residues Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes (SANTE/2020/12830) (12) |
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US EPA OPPTS 885.3400 hypersensitivity Incidents |
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US EPA OPPTS 885.3050 Acute Oral Toxicity/ Pathogenicity |
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US EPA OPPTS 885.3150 Acute pulmonary toxicity/ pathogenicity |
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US EPA OPPTS 885.3200 Microbial pesticide test guidelines. Acute injection toxicity/pathogenicity |
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US EPA OPPTS 885.3500 Cell culture |
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US EPA OPPTS 885.3600 Subchronic Toxicity/Pathogenicity |
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US EPA OPPTS 885.3650 Reproductive/fertility effects |
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European Commission draft guidance document Guidance for the setting of an acute reference dose (ARfD) (7199/VI/99) |
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ECHA Guidance on the application of the CLP criteria. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures |
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EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708) |
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OECD Series on Testing and Assessment No. 124, Guidance for the Derivation of an Acute Reference Dose. (ENV/JM/MONO(2010)15) |
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EFSA Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Journal 2019;17(6):5708) |
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EFSA Guidance document on clustering and ranking of emissions of active substances of plant protection products and transformation products of these active substances from protected crops (greenhouses and crops grown under cover) to relevant environmental compartments, Section 2 (EFSA Journal 2014;12(3):3615) |
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EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.1.2 (SANCO/12117/2012) |
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EFSA Guidance document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil, section 2.7 ‘Applicability of the tiered assessment scheme for microbial actives substances’ (EFSA Journal 2017;15(10):4982) |
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EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents, section 3.2.1 (SANCO/12117/2012) |
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Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (based on –among others- Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)) |
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Generic guidance for Tier 1 FOCUS Ground water assessments (based on –among others-the European Commission (2014) Assessing Potential for Movement of Active Substances and their Metabolites to Ground Water in the EU - Final Report of the Ground Water Work Group of FOCUS (Sanco/13144/2010); FOCUS (2000) ‘FOCUS groundwater scenarios in the EU review of active substances’ Report of the FOCUS Groundwater Scenarios Workgroup (Sanco/321/2000); Scientific Opinion of the Panel on Plant Protection Products and their Residues on a request from EFSA related to the default Q10 value used to describe the temperature effect on transformation rates of pesticides in soil.(doi: 10.2903/j.efsa.2008.622); Generic Guidance for Estimating Persistence and Degradation Kinetics from Environmental Fate Studies in Pesticides in EU Registration (including Guidance Document on Estimating Persistence and Degradation Kinetics from Environmental Fate Studies on Pesticides in EU Registration - Final Report of the Work Group on Degradation Kinetics of FOCUS (Sanco/10058/2005); Guidance Document for evaluating laboratory and field dissipation studies to obtain DegT50 values of active substances of plant protection products and transformation products of these active substances in soil (SANCO/12117/2014)); section 3.3.1 of European Food Safety Authority. Guidance Document for predicting environmental concentrations of active substances of plant protection products and transformation products of these active substances in soil (doi:10.2903/j.efsa.2017.4982); section 3.3 of Scientific report of EFSA on the ‘repair action’ of the FOCUS surface water scenarios (doi:10.2903/j.efsa.2020.6119)) |
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The relevant methods indicated under this Section may need to be adapted on a case-by-case basis. Hence the applicability of the methods selected, or adaptations of them, must be justified in light of the biological and ecological characteristcs of the active substance to be assessed and it may be discussed in pre-submission meetings. |
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EU Working document to the Environmental Safety Evaluation of Microbial Biocontrol Agents (SANCO/12117/2012) |
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US EPA 885.4000 (1996) Background for non-target organism testing of microbial pest control agents |
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Environment and Climate Change Canada (2016), guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44) |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44), 14.1 Birds |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS1/RM/44), 14.1 Birds |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 14.2 Small Mammals |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 14.2 Small Mammals |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 11.1 Freshwater Fish |
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OECD Test No. 203 (2019) Fish, Acute Toxicity Test |
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OECD Test No. 210 (2013) Fish, Early-life Stage Toxicity Test |
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US EPA OCSPP 885.4200 freshwater fish Tier I |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 11.1 Freshwater Fish |
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OECD Test No. 233 (2010) Sediment-Water Chironomid Life-Cycle Toxicity Test Using Spiked Water or Spiked Sediment |
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US EPA OCSPP 885.4240 Freshwater invertebrate Tier I |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 10.1 Freshwater Invertebrates |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 10.1 Freshwater Invertebrates |
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OECD Test No. 201 (2011) Freshwater Alga and Cyanobacteria, Growth Inhibition Test |
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US EPA OCSPP 885.4300 Non target plant studies Tier I |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 9.1 Freshwater plants |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 9.1 Freshwater plants |
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OECD Test No. 221 (2006): Lemna sp. Growth Inhibition Test |
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OECD Test No. 239 (2014): Water-Sediment Myriophyllum Spicatum Toxicity Test |
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OECD Test No. 238 (2014): Sediment-Free Myriophyllum Spicatum Toxicity Test |
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OECD Test Guideline 213 Honeybees, Acute Oral Toxicity Test |
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OECD Test Guideline 214 Honeybees, Acute Contact Toxicity Test. |
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OECD Test Guideline 245 Honey Bee, Chronic Oral Toxicity Test |
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OECD guidance document 239 Honey Bee Larval Toxicity Test, Repeated Exposure |
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OECD guidance document 75: Honey Bee Brood Test Under Semi-Field Conditions |
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EPPO Bulletin (2019) 49 Oomen Bee Brood Feeding Test |
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EPPO Bulletin (2010) 40 Side-Effects On Honeybees |
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OECD Test No. 247 (2017) Bumblebee, Acute Oral Toxicity Test |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.1 Honey bees |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.1 Honey bees |
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US EPA OCSPP 885.4380 Honey bee Tier I |
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US EPA OCSPP 885.4340 Non-target Insect Tier I |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.1 Tests for Plant-Dwelling Invertebrates |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.1 Tests for Plant-Dwelling Invertebrates |
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OECD Test No. 222 (2016): Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) |
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OECD Test No. 232 (2016): Collembolan Reproduction Test in Soil |
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OECD Test No. 226 (2016): Predatory mite (Hypoaspis (Geolaelaps) aculeifer) reproduction test in soil |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.2 Springtails |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.2.2 Springtails |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.2 Earthworms |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 13.3.2 Earthworms |
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OECD Test No. 227 (2006): Terrestrial Plant Test: Vegetative Vigour Test |
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OECD Test No. 208 (2006): Terrestrial Plant Test: Seedling Emergence and Seedling Growth Test |
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Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 12.2 Terrestrial plants |
Environment and Climate Change Canada (2016) Guidance document for testing the pathogenicity and toxicity of new microbial substances to aquatic and terrestrial organisms (EPS 1/RM/44), 12.2 Terrestrial plants |
(1) Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (OJ L 227, 1.9.2022, p. 8).
(2) Article 32a of 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, 1.2.2002, p. 1).
(3) OJ L 276, 20.10.2010, p. 33.
(5) Available at https://publications.jrc.ec.europa.eu/repository/
(6) Most of the test methods cited are only available in English. Detailed information about the test methods:
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ISO http://www.iso.org/iso/home/store/catalogue_ics.htm |
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OECD http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/ |
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EPPO http://www.eppo.int/STANDARDS/standards.htm |
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US EPA OCSPP https://www.epa.gov/ |
(7) Most of the guidance documents cited are available only in English. Detailed information about the guidance documents:
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European Commission: https://food.ec.europa.eu/plants/pesticides/approval-active-substances/guidelines-active-substances-and-plant-protection-products_en |
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OECD http://www.oecd.org/env/chemicalsafetyandbiosafety/testingofchemicals/ |
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EPPO: http://www.eppo.int/STANDARDS/standards.htm |
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ECHA: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation |
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EFSA: http://www.efsa.europa.eu/en/publications.htm |
(8) Please consider only those uses which are deemed relevant under the scope of Reg (EC) No 1107/2009, and not those in EPPO PP 1/248 which refer to biostimulant claims as defined both under the scope of Reg (EU) No 2019/1009 and under the technical specifications CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4, CEN/TS 17700-5, even if these biostimulants are identified as plant growth regulators in EPPO PP 1/248.
(9) https://gd.eppo.int/
(10) Please consider only those uses which are demeed relevant under the scope of Reg (EC) No 1107/2009, and not those in EPPO PP 1/248 which refer to biostimulant claims as defined under the scope of Reg (EU) No 2019/1009 and the technical specifications CEN/TS 17724, CEN/TS 17700-1, CEN/TS 17700-2, CEN/TS 17700-3, CEN/TS 17700-4, CEN/TS 17700-5, even if they are identified as plant growth regulators in EPPO PP1/248.
(11) https://efsa.onlinelibrary.wiley.com/action/downloadSupplement?doi=10.2903/j.efsa.2011.2092&file=efs22092-sup-0001-Appendix.pdf
(12) if relevant for residues of metabolites of concern.