A new technical guide:
HEALTH/11956/2016 rev 9 for determining pesticide residue levels and setting maximum residue limits in honey will be applicable from 1 January 2020.
It will therefore apply to all reviews and applications submitted by an applicant to a Member State from that date.
This document was approved by the Standing Committee for Plants, Animals, Food and Feed at its meeting on 18-19 September 2018.
Honey is a commodity that may contain residues of plant protection products (PPPs) through the exposure of bees during the collection of nectar and pollen. It is therefore appropriate to establish safe maximum residue limits (MRLs) for consumers.
Until now, no methodology for setting MRLs in honey had been established. Therefore, MRLs on honey are set at the detection limit of 0.05mg/kg.
According to Regulation (EU) No 283/2013 laying down data requirements for active substances, a residue concentration study in pollen and apiculture products must be carried out.
This guide is therefore intended to provide additional technical information and data necessary for the establishment of MRLs in honey. Consumption of pollen, royal jelly, propolis and beeswax is negligible, so experimental residue data need not be generated for these products.
As with other food products, a residue definition must be established for honey.
This must take into account toxicologically relevant compounds resulting from the use of pesticides on crops collected by bees.
This residue definition may include:
- the original substance and metabolite(s) included in the residue definition on primary crops
- degradation products formed during the pasteurisation process
- metabolites included in the residue definition of the risk assessment for rotational crops and/or a compound remaining in the soil after application of the active substance.
The guide has set up a decision tree in APPENDIX I to establish the MRL for honey.
You will find below the main lines of this diagram:
1) Are pesticide residues likely to be detected in honey?
- If residues in honey are not expected (the substance is applied to a crop from which it is not possible to produce honey, 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 establish a default MRL at the limit of quantification (LOQ) determined for the active substance in honey. In the absence of a specific level of quantification in honey for the active substance concerned, the default value of 0,05 *mg/kg may be used.
- If residues in honey are expected taking into account the proposed uses and properties of the active substance, additional data on crop/field tests are required.
In this case, it is advisable to consider the most critical scenario.
The test must:
- Be carried out on a high-capacity rapeseed-type honey crop 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 it is possible to produce honey.)
- Use the highest application rate.
In order to obtain reliable results, residues in honey must be determined as soon as possible after collection and at the latest 30 days later.
2) What is the amount of residue in the aerial parts of the crop?
- 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.
- If the highest residue concentration in the aerial parts of plants is ≥ at the threshold value of 0.05 mg/kg and < 0.5 mg / kg, a proposal for an MRL may be established on the basis of the highest residue level.
- If the highest residue level determined in the aerial parts is ≥ at 0.5 mg/kg, further studies are required to set the lowest possible MRL. These are carried out with treated syrup (syrup enriched with mother compound and its metabolites) or via attractive cultures treated in tunnels.
Annex III of the guide contains additional information on syrup testing and Annexes IV and V contain additional guidance on conducting field and tunnel tests.
3) Is the active substance used in a veterinary medicinal product?
Lastly, it should always be checked whether the active substance is also used as a veterinary medicinal product in the treatment of the hive (control of bee diseases or parasites).
If an MRL is already set in Regulation (EU) No 37/2010, it is necessary to:
- Compare the two residue definitions for monitoring and risk assessment
- Verify that the MRL set by veterinary regulations for honey also takes into account the possible uses of PPPs
If the MRL defined in Regulation No 37/2010 is > the MRL taking into account the uses of PPPs, a consumer risk assessment must be carried out using EFSA's PRIMo model.
If it proves to be safe for consumers, it can be included in Regulation (EC) No 396/2005.
If the MRL set in Regulation No 37/2010 is < the MRL taking into account the uses of PPPs, the procedure described in points 1) and 2) should be used to define the appropriate MRL.
The Phytocontrol laboratory, an expert in the field of analysis, will assist you in setting up and carrying out your PPP residue tests. Our expertise in honey and hive products, and our GLP recognition are the foundation for successful testing.
Feel free
to contact us for more details.
