{"id":8297,"date":"2019-03-04T11:51:08","date_gmt":"2019-03-04T10:51:08","guid":{"rendered":"http:\/\/www.phytocontrol.com\/?p=8297"},"modified":"2026-08-28T01:48:03","modified_gmt":"2026-08-27T23:48:03","slug":"evaluation-of-ppp-residues-on-bees-and-beehive-products","status":"publish","type":"post","link":"https:\/\/dev.phytocontrol.com\/en\/regulatory-watch\/evaluation-of-ppp-residues-on-bees-and-beehive-products\/","title":{"rendered":"Assessment of PPP residues in bees and bee products"},"content":{"rendered":"<p>A new technical guide: <a href=\"https:\/\/www.phytocontrol.com\/wp-content\/uploads\/2019\/03\/pesticides_mrl_guidelines_honey.pdf\">SANTE\/11956\/2016 rev 9<\/a>, enabling pesticide residue levels to be determined and maximum residue levels to be set in honey, will be applicable from 1 January 2020.<\/p>\n<p>It will therefore apply to all reviews and all applications submitted by an applicant to a Member State from that date onwards.<\/p>\n<p>This document was approved by the Standing Committee on Plants, Animals, Food and Feed at its meeting on 18 and 19 September 2018.<\/p>\n<p>Honey is a food that may contain residues of plant protection products (PPPs) due to bees&#8217; exposure during nectar and pollen collection. Safe maximum residue levels (MRLs) for consumers must therefore be established.<\/p>\n<p>Until now, no methodology for setting MRLs in honey had been established. As a result, MRLs for honey are set at the detection threshold of 0.05 mg\/kg.<\/p>\n<p>Under Regulation (EU) No 283\/2013 establishing data requirements for active substances, a study of residue concentration in pollen and beekeeping products must be carried out.<\/p>\n<p>This guide is therefore intended to provide additional technical information and the data needed to establish MRLs in honey. As consumption of pollen, royal jelly, propolis and beeswax is negligible, it is not necessary to generate experimental residue data for these products.<\/p>\n<p>As with other food products, a residue definition must be established for honey.<\/p>\n<p>This must take into account compounds that are toxicologically relevant and result from the use of pesticides on crops foraged by bees.<\/p>\n<p>This residue definition may include:<\/p>\n<p>&#8211; The parent substance and metabolite(s) included in the residue definition for primary crops<\/p>\n<p>&#8211; Degradation products formed during the pasteurisation process<\/p>\n<p>&#8211; Metabolites included in the residue definition from the risk assessment for rotational crops and\/or a compound remaining in the soil after application of the active substance.<\/p>\n<p>The guide sets out a decision tree in ANNEX I for establishing the MRL for honey.<\/p>\n<p>Below is an outline of this decision tree:<\/p>\n<p><strong><u>1) Are pesticide residues likely to be detected in honey?<\/u><\/strong><\/p>\n<ul>\n<li>If residues in honey <u>are not expected<\/u> (the substance is applied to a crop from which honey cannot be produced, the substance has no systemic properties and is not applied during the flowering period, or the substance has systemic properties but is applied after the flowering period and is not persistent), it is recommended to set a default MRL at the limit of quantification (LOQ) determined for the active substance in honey. In the absence of a specific quantification limit in honey for the active substance in question, the default value of 0.05 mg\/kg may be used.<\/li>\n<\/ul>\n<ul>\n<li>If residues in honey <u>are expected<\/u> given the proposed uses and the properties of the active substance, additional data from crop\/field trials are required.<\/li>\n<\/ul>\n<p>In this case, the most critical scenario should be considered.<\/p>\n<p>The trial must:<\/p>\n<p>&#8211; Be conducted on a crop with high nectar-producing capacity, such as oilseed rape, even if it is not part of the proposed uses (Annex II of the guide contains a list of the main agricultural crops in Europe from which honey can be produced.)<\/p>\n<p>&#8211; Use the highest application rate.<\/p>\n<p>To obtain reliable results, residues in honey must be determined as soon as possible after collection and no later than 30 days afterwards.<\/p>\n<p><strong><u>2) What is the amount of residue in the aerial parts of the crop?<\/u><\/strong><\/p>\n<ul>\n<li>If the maximum residue concentration measured in the aerial parts is < the threshold value of 0.05 mg\/kg, a default MRL of 0.05 mg\/kg may be set.<\/li>\n<\/ul>\n<ul>\n<li>If the highest residue concentration in the aerial parts of the plants is \u2265 the threshold value of 0.05 mg\/kg and < 0.5 mg\/kg, a proposed MRL can be established based on the highest residue level.<\/li>\n<\/ul>\n<ul>\n<li>If the highest residue level determined in the aerial parts is \u2265 0.5 mg\/kg, further studies are needed to set the lowest possible MRL. These are carried out using treated syrup (syrup enriched with the parent compound and its metabolites) or via attractive crops treated under tunnels.<\/li>\n<\/ul>\n<p>Annex III of the guide contains additional information on syrup trials, and Annexes IV and V contain further guidance on conducting field and tunnel trials.<\/p>\n<p><strong><u>3) Is the active substance used in a veterinary medicine?<\/u><\/strong><\/p>\n<p>Finally, it should always be checked whether the active substance is also used as a veterinary medicine to treat hives (control of bee diseases or parasites).<\/p>\n<p>If an MRL has already been set in Regulation (EU) No 37\/2010, it is necessary to:<\/p>\n<p>&#8211; Compare the two residue definitions for monitoring and risk assessment purposes<\/p>\n<p>&#8211; Verify that the MRL set by veterinary legislation for honey also takes into account possible PPP uses<\/p>\n<p>If the MRL defined in Regulation No 37\/2010 is > the MRL taking PPP uses into account, a consumer risk assessment must be carried out using EFSA&#8217;s PRIMo model.<\/p>\n<p>If it is shown to be safe for consumers, it may be included in Regulation (EC) No 396\/2005.<\/p>\n<p>If the MRL set in Regulation No 37\/2010 is < the MRL taking PPP uses into account, the procedure described in points 1) and 2) should be used to define the appropriate MRL.\n\nPhytocontrol laboratory, an expert in the field of analysis, supports you in setting up and carrying out your PPP residue tests. Our expertise in honey and bee product matrices, together with our GLP recognition, will be put to use to successfully carry out your tests.\n\nPlease <span style=\"color: #ed910d;\"><a style=\"color: #ed910d;\" href=\"https:\/\/dev.phytocontrol.com\/en\/contact-phytocontrol\/\">contact us<\/a><\/span> for further details.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A new technical guide: SANTE\/11956\/2016 rev 9, enabling pesticide residue levels to be determined and&hellip;<\/p>\n","protected":false},"author":2,"featured_media":8290,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[181],"tags":[],"class_list":["post-8297","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-watch"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.4 (Yoast SEO v28.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Assessment of PPP residues in bees and bee products - 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