Commission Regulation (EU) No 283/2013Dangos y teitl llawn

SECTION 6 U.K. Residues in or on treated products, food and feed

6.1. Storage stability of residues U.K.

Studies concerning storage stability of residues shall investigate the stability of residues in plants, plant products and products of animal origin during storage prior to analysis.

Circumstances in which required U.K.

Provided that samples are frozen within 24 hours after sampling and unless a compound is otherwise known to be volatile or labile, stability data shall not be required for samples extracted and analysed within 30 days from sampling (six months in the case of radio-labelled material).

The stability of extracts shall be investigated if extracts are not analysed immediately.

Test conditions U.K.

Studies with non-radio-labelled active substances shall be carried out with representative substrates. They may be either performed on samples from treated crops or animals with incurred residues or by fortification experiments. In the latter case, aliquots of prepared control samples shall be spiked with a known amount of chemical before storage under normal storage conditions.

The studies shall address stability of individual components of the residue definition relevant to risk assessment, which may require spiking different samples with different analytes. In case of different analytical targets (for example targeting either single compounds or a common moiety) more than one set of storage stability data may be needed.

The duration of the stability studies shall be suitable to address the length over which the samples or extracts have been stored in the corresponding studies.

Detailed information with respect to the sample preparation and storage conditions (temperature and duration) of samples and extracts shall be submitted. Where the degradation during storage is significant (more than 30%) a change in the storage conditions or not storing the samples prior to analysis shall be considered. All studies where unsatisfactory storage conditions were used shall be repeated.

Storage stability data using sample extracts shall also be required unless samples are analysed within 24 hours of extraction.

Results shall be presented as absolute values in mg/kg and not adjusted by recovery, as well as percentage of nominal spike value.

6.2. Metabolism, distribution and expression of residues U.K.

Data on metabolism representative for existing or intended good agricultural practices (GAPs) shall be provided, together with a schematic diagram of the metabolic pathways in plants and animals with a brief explanation of the distribution and chemical reactions involved. These studies shall be conducted with one or more radio-labelled forms of the active substance and, where relevant, stereoisomer forms of the active substance and its metabolites. For plant extracts, a different approach may be taken if adequately justified.

For plants, the objectives of these studies shall be:

(a)

to provide an estimate of total terminal residues in the relevant portion of crops at harvest following treatment as proposed;

(b)

to identify the major components of the total terminal residue;

(c)

to indicate the distribution of residues between relevant crops parts;

(d)

to quantify the major components of the residue and to show the efficiency of extraction procedures for these components;

(e)

to characterise and quantify conjugated and bound residues;

(f)

to indicate the components to be analysed for in residue quantification studies (crop residue studies).

For food producing animals, the objectives of these studies shall be:

(a)

to provide an estimate of total terminal residues in edible animal products;

(b)

to identify the major components of the total terminal residue in edible animal products;

(c)

to indicate the distribution of residues between relevant edible animal products;

(d)

to provide evidence whether or not a residue should be classified as fat soluble;

(e)

to quantify the total residue in certain animal products (milk or eggs) and excreta;

(f)

to quantify the major components of the residue and to show the efficiency of extraction procedures for these components;

(g)

to characterise and quantify conjugated and bound residues;

(h)

to indicate the components to be analysed for in residue quantification studies (livestock feeding studies);

(i)

to generate data from which a decision on the need for feeding studies on food producing animals can be made.

The results of the metabolism study conducted with poultry, normally laying hens, shall be extrapolated to all food producing poultry whereas the results of the metabolism study conducted with ruminants, normally lactating goats and, where necessary, with pigs, shall be extrapolated to all food producing mammals.

Metabolites not found in the ADME studies or that cannot be explained as intermediates, but identified in metabolism/transformation studies (plant, food producing animals, processing and rotational crops) shall be considered relevant for the consumer risk assessment, unless it can be demonstrated by scientific evidence (such as structure-activity relationship, toxicological bridging studies) that, also in view of their concentration, they cause no potential risks to the consumer.

6.2.1. Plants U.K.

Circumstances in which required U.K.

Studies on plants shall be performed unless no part of the plants or plant products will be used as food or feed material or unless a ‘zero’ residue situation applies (such as bait applications).

Test conditions U.K.

The intended method of application (such as seed treatment, soil/foliar spraying, dipping, fogging) and the properties of the active substance (such as systemic properties or volatility) shall be taken into account when planning metabolism studies. Metabolism studies have to involve crops from different categories of crops in which plant protection products containing the active substance in question would be used. For this purpose crops shall be considered as falling into one of the following categories:

(a)

fruit (code F);

(b)

root crops (code R);

(c)

leafy crops (code L);

(d)

cereal/grass crops (code C/G);

(e)

pulses and oilseeds (code P/O);

(f)

miscellaneous.

The category ‘miscellaneous’ shall only be used on a case by case basis.

A metabolism study shall be submitted for each type of crop group for which use is proposed. In order to extrapolate results from metabolism studies with an active substance to all crop groups, metabolism studies on a minimum of three representative crops (from the different crop groups except ‘miscellaneous’) shall be conducted. If the results of these three studies indicate a comparable metabolic route (qualitatively and to a lesser extent quantitatively), then additional studies shall not be needed. If the results from the available studies from three of these categories indicate that the route of degradation is not similar in all three categories, studies from the remaining categories except ‘miscellaneous’ shall be provided.

If authorisation is sought for one crop group only, metabolism studies in one crop from that crop group shall be sufficient as long as the crop is truly representative of the crop group and the metabolic pathway is elucidated.

The studies shall reflect the intended use pattern of the active ingredient such as foliar, soil/seed or post-harvest treatments. If, for instance, three studies have been conducted using foliar application and at a later date soil application (such as seed treatment, granular or soil drench) is proposed, then at least one additional study reflecting soil application shall be conducted. The applicant shall discuss with the national competent authorities the possible replacement of a foliar study with a post-harvest study.

An evaluation of the results from different studies shall be submitted on:

(a)

the site of uptake (for example via leaves or roots);

(b)

the formation of metabolites and breakdown products;

(c)

the distribution of residues between relevant parts of the crop at harvest (with particular emphasis on food and feed);

(d)

the metabolic pathways.

If studies show that the active substance or relevant metabolites or breakdown products are not taken up by the crop, a rationale shall be given.

6.2.2. Poultry U.K.

Circumstances in which required U.K.

Metabolism studies on poultry shall be provided where the plant protection product is to be used in crops whose parts or products, also after processing, are fed to poultry and where the intake is expected to exceed 0,004 mg/kg bw/day(1).

Test conditions U.K.

Studies shall be carried out in laying hens.

Dose rates shall be at least equivalent to the likely maximum daily exposure resulting from all intended uses.

If the identification of metabolites cannot be carried out with dose rates of 10 mg/kg feed (dry matter), higher doses may be used.

If no feeding studies are carried out, plateau levels in eggs shall be demonstrated in the metabolism study taking into account that plateau levels usually occur no later than 14 days from the beginning of dosing in laying poultry.

6.2.3. Lactating ruminants U.K.

Circumstances in which required U.K.

Metabolism studies on lactating ruminants shall be provided where the plant protection product is to be used in crops whose parts or products, also after processing, are fed to ruminants and where the intake is expected to exceed 0,004 mg/kg bw/day.

Test conditions U.K.

Studies shall be carried out in lactating goats, where available, or in lactating cows as an alternative.

Dose rates shall at least be equivalent to the likely maximum daily exposure resulting from all intended uses.

If the identification of main metabolites cannot be carried out with dose rates of 10 mg/kg feed (dry matter), higher doses may be used.

If no feeding studies are carried out, plateau levels in milk shall be demonstrated in the metabolism study taking into account that plateau levels usually occur five to seven days after the beginning of dosing in lactating ruminants.

6.2.4. Pigs U.K.

Circumstances in which required U.K.

Metabolism studies on pigs shall be provided where the plant protection product is used in crops whose parts or products, also after processing, are fed to pigs and where it becomes apparent that metabolic pathways differ significantly in the rat as compared to ruminants and where the intake is expected to exceed 0,004 mg/kg bw/day.

Test conditions U.K.

Studies shall be carried out in pigs.

Dose rates shall at least be equivalent to the likely maximum daily exposure resulting from all intended uses.

If the identification of metabolites cannot be carried out with dose rates of 10 mg/kg feed (dry matter), higher doses may be used.

The duration of this study shall be the same as for lactating ruminants.

6.2.5. Fish U.K.

Circumstances in which required U.K.

Metabolism studies on fish may be required where the plant protection product is used in crops whose parts or products, also after processing, are fed to fish and where residues in feed may occur from the intended applications.

Results from studies provided for under point 8.2.2.3 may be used if it can be demonstrated with scientific evidence that the results of these studies may be assumed to be equivalent. Special consideration shall be given to the different routes of ingestion.

6.3. Magnitude of residue trials in plants U.K.

The objectives of magnitude of residue trials in plants shall be the following:

• to quantify the highest likely residue levels of all components of the different residue definitions in treated crops, at harvest or outloading from store, in accordance with the proposed GAP, and

• to determine, where appropriate, the decline rate of plant protection product residues in plants.

Circumstances in which required U.K.

These studies shall always be performed where the plant protection product is to be applied to plants or plant products that are used as food or feed or where residues from soil or other substrates can be taken up by such plants except where extrapolation from adequate data on another crop is possible.

When planning residue trials, it shall be borne in mind that information on the residues in ripe or unripe crops may be of interest with respect to the risk assessment in other areas like ecotoxicology or worker safety.

Test conditions U.K.

Supervised residue trials shall correspond to the proposed critical GAP. The test conditions (such as maximum number of proposed applications, shortest interval between applications, maximum application rate and concentration, most critical safety intervals(2) with regard to exposure) shall be defined to identify the highest residues which may reasonably arise and shall be representative of the realistic conditions at the critical GAP in which the active substance is to be used.

When establishing a supervised residue trial programme, factors such as main growing areas and the range of conditions, likely to be encountered in the main growing areas concerned shall be considered.

Differences in agricultural production methods (for example outdoor versus indoor uses), seasons of production and types of formulations shall be taken into account.

For the evaluation of residue behaviour and the setting of maximum residue levels (MRLs) according to Regulation (EC) No 396/2005, the Union shall be divided into two zones, a Northern European and a Southern European zone. For the purpose of use in greenhouses, as post-harvest treatment and for treatment of empty storage rooms, one residue zone shall apply.

The number of trials necessary is difficult to determine before the evaluation of their results. Assuming all other variables having an impact on the residue levels are comparable, the minimum number of trials shall vary for each residue zone between a minimum of 4 trials for a minor crop and a minimum of 8 trials for a major crop.

However, if the GAP is the same in both residue zones, 6 trials equally distributed in the representative growing zones are normally sufficient for a minor crop.

The number of studies to be performed may be reduced if residue trials show that the residue levels in plants or plant products are lower than the LOQ. The number of trials shall not be below the minimum of three per zone for minor crops and four per zone for major crops.

In cases were a ‘zero’ residue situation is predicted from representative plant metabolism studies, three trials shall be performed for commodities significant in diet. No trials shall be required for commodities insignificant in diet. A ‘zero’ residue situation shall be predicted where no detectable residues occur in studies with exaggerated application rates compared to the envisaged ones.

Provided that conditions are comparable and that trials are widely spread over different zones, it shall be sufficient to carry out trials over one growing season.

Part of the trials may be replaced by trials performed outside the Union, provided that they correspond to the critical GAP and that the production conditions (such as cultural practices, climatic conditions) are comparable.

Trials showing the residue behaviour in post-harvest treatments shall be carried out at different locations with different cultivars. A set of trials shall be carried out for each application method and storage condition, unless the worst case residue situation can be clearly identified.

Where a plant protection product has both a field use and an indoor use with the same GAP, a full data package shall be submitted for both situations, unless it is already accepted that one use is the critical GAP.

It shall be checked on a case-by-case basis, taking into account plant morphology and application conditions, whether extrapolation from the crop used for the metabolism study to other crops belonging to the same crop group is possible.

Where a significant part of the consumable commodity is present at the time of application, half of the supervised residue trials reported shall include data to show the effect of time on the level of residue present (residue decline studies), unless the consumable part is not exposed during application of the plant protection product under the proposed conditions of use. For crops harvested after blossom (such as fruits or fruiting vegetables) a significant part of the consumable crop is present from full blossom (BBCH 65) onwards. In case of most crops from which leafy parts are harvested (for example lettuce), this condition is satisfied if 6 true leaves, leaf pairs or whorls are unfolded (BBCH 16).

In case of an active substance for which an ARfD has been derived, the distribution of residues among single units may be investigated through variability studies. If a sufficient number of results is available, the default variability factor may be replaced by a specific factor derived from these studies.

6.4. Feeding studies U.K.

The objective of feeding studies shall be to determine residues in products of animal origin which result from residues in feed.

The results from a feeding study conducted with laying hens shall be extrapolated to all food producing poultry. The results from a feeding study with lactating cows and, where necessary, with pigs shall be extrapolated to all food producing mammals.

Circumstances in which required U.K.

Feeding studies shall be provided where metabolism studies indicate that residues at levels of above 0,01 mg/kg may occur in edible animal tissue, milk, eggs or fish, taking into account the residue levels in potential feeding stuffs, obtained at the 1 × dose rate, calculated on the dry weight basis.

Feeding studies shall not be required where intake is below 0,004 mg/kg bw/day, except in cases where the residue, that is to say the active substance, its metabolites or breakdown products, as defined in the residue definition for risk assessment, tends to accumulate.

6.4.1. Poultry U.K.

Poultry feeding studies shall be carried out in laying hens. For each treatment regime chosen a minimum of nine chickens should be treated.

In general, the feed shall be administered in three dosages (first dose = expected residue level). The animals shall be dosed for a minimum of 28 days or until plateau level is reached in eggs.

6.4.2. Ruminants U.K.

Ruminant feeding studies shall be carried out in lactating cows. For each treatment regime chosen, a minimum of three dairy cows shall be treated.

In general, the feed shall be administered in three dosages (first dose = expected residue level). The animals shall be dosed for a minimum of 28 days or until plateau level is reached in milk.

6.4.3. Pigs U.K.

Where it appears from the metabolism studies that metabolic pathways differ significantly in pigs as compared to ruminants, a pig feeding study may be conducted. For each treatment regime chosen a minimum of three pigs shall be treated.

In general, the feed shall be administered in three dosages (first dose = expected residue level). The animals shall be dosed for at least the same time as ruminants.

6.4.4. Fish U.K.

A fish feeding study may be required where residues at levels above 0,01 mg/kg may be reasonably expected in edible tissues, based on the findings of the fish metabolism study and the estimated maximum residues which might occur in fish feed. Particular attention should be laid on lipophilic substances with an intrinsic tendency for accumulation.

6.5. Effects of processing U.K.

6.5.1. Nature of the residue U.K.

The objective of studies on the nature of the residue shall be to establish whether or not breakdown or reaction products arise from residues in the raw agricultural commodity during processing, which may require a separate risk assessment.

Circumstances in which required U.K.

Studies on the nature of residues in processing shall be provided where residues in products of plant or animal origin subject to processing may occur at a level of or higher than 0,01 mg/kg (based on the residue definition for risk assessment for the raw commodity). No studies shall, however, be required in the following cases:

• substances with a water solubility < 0,01 mg/L;

• only simple physical operations, not involving a change in temperature of the commodity are carried out, such as washing, trimming or pressing; or

• the distribution of residues between pulp and inedible peel is the only effect of processing.

Test conditions U.K.

Depending upon the expected level and chemical nature of the residue in the product of plant or animal origin, a set of representative hydrolysis situations simulating the relevant processing operations shall be investigated, where appropriate. Consideration shall also be given to the effects of processes other than hydrolysis and the potential for the formation of toxicologically significant breakdown products.

The studies shall be conducted with one or more radio-labelled forms of the relevant substance.

6.5.2. Distribution of the residue in inedible peel and pulp U.K.

The objectives of studies concerning distribution of the residue in inedible peel and pulp shall be:

• to determine the quantitative distribution of residues between inedible peel and pulp,

• to estimate peeling factors, and

• to allow a more realistic estimation of dietary intake of residues.

Circumstances in which required U.K.

These studies shall be provided for plant products where the peel is either inedible (such as melons, bananas) or is very rarely entirely eaten by consumers (such as citrus fruit).

Test conditions U.K.

These studies shall be performed as part of supervised residue trials, the number of results reported depending on the number of residue trials conducted. Special attention shall be paid to possible contamination of the pulp. Precautionary measures shall be taken in order to quantify a realistic highest residue level.

6.5.3. Magnitude of residues in processed commodities U.K.

The main objectives of studies concerning magnitude of residues in processed commodities shall be:

• to determine the quantitative distribution of residues in the various processed commodities used as food or feed,

• to estimate processing factors, and

• to allow a more realistic estimation of dietary intake of residues.

Circumstances in which required U.K.

The following points shall be taken into consideration when deciding whether it is necessary to carry out processing studies:

(a)

the dietary burden of a processed product in the human (such as apples) or animal diet (such as apple pomace);

(b)

the level of residue in the plant or plant product to be processed (normally ≥ 0,1 mg/kg);

(c)

the physical and chemical properties of the active substance and its relevant metabolites (such as fat-solubility in case of oil seed processing); and

(d)

the possibility that breakdown products of toxicological significance may occur after processing of the plant or plant product.

If the level of residues is less than 0,1 mg/kg, processing studies shall be carried out if the contribution of the commodity under consideration to the theoretical maximum daily intake (TMDI) is ≥ 10 % of the ADI or if the estimated daily intake is ≥ 10 % of the ARfD for any European consumer group diet.

Processing studies shall not be required if plants or plant products are exclusively used raw (unprocessed) for food and feed purposes.

In some cases, a simple calculation shall be sufficient to determine the processing factor such as concentration from dehydration or dilution factors, as long as the process under consideration is not expected to have an influence on the nature of residues.

Industrial processing U.K.

If the properties of the active substance, the impurity or the metabolite, as appropriate, indicate that it might concentrate in a given processed fraction, then a processing study shall be necessary even in situations where the residue in the plant or plant product to be processed is lower than 0,1 mg/kg. In such cases, exaggerated application rates up to 5 × or shortened PHIs shall be applied where necessary to achieve a quantifiable residue in the plant or plant product to be processed. A processing study shall not be required if exaggerated application rates (up to 5 ×) fail to yield a quantifiable residue in the plant or plant product to be processed. Phytotoxicity shall be considered when contemplating exaggerated rate treatments.

Domestic processing U.K.

For domestic or home transformation processes and minor industrial ones, when no residues are found at or above 0,1 mg/kg in the raw agricultural commodity at recommended GAP from supervised field trials conducted at the maximum label rate and minimum PHI, no processing studies shall be required.

Test conditions U.K.

Processing studies shall represent domestic preparations (for example cooked vegetables) or commercial industrial processes (for example production of apple juice). Processing studies shall be carried out at least on a representative crop of a crop group, where use is envisaged. The choice of the crop and of the process shall be justified and explained.

The technology used in processing studies shall correspond as closely as possible to the actual conditions that are normally used. For each crop to be investigated two studies per process shall be carried out to determine concentration and dilution factors in processed commodities. If more than one processing method is in use, the one which is expected to give the highest residues in the processed product for human consumption shall be chosen. The results shall be extrapolated to all crops within a crop group undergoing the same process.

When the results (processing factor) of the two studies differ in the main processed products by more than 50 %, further studies shall be provided to derive a consistent processing factor.

Additional studies shall be carried out if, when using processing factors derived by extrapolation, the estimate of the dietary intake exceeds the ADI or ARfD. Those studies shall be carried out on major processes and commodities which contribute most to the ADI/ARfD exceedance.

6.6. Residues in rotational crops U.K.

Studies concerning residues in rotational crops shall be performed to allow the determination of the nature and extent of potential residue accumulation in rotational crops from soil uptake and of the magnitude of residues in rotational crops under realistic field conditions.

Rotational crop studies shall not be required for uses of plant protection products in permanent crops (such as citrus and pome fruits crop group), semi-permanent crops (such as asparagus, pineapples) or fungi, where rotations on the same substrate are not part of the normal agricultural practices.

6.6.1. Metabolism in rotational crops U.K.

The objectives of metabolism studies in rotational crops shall be:

(a)

to provide an estimate of the total terminal residues in the relevant portion of crops at harvest of rotational crops following treatment of the preceding crop as proposed;

(b)

to identify the major components of the total terminal residue;

(c)

to indicate the distribution of residues between relevant crop parts;

(d)

to quantify the major components of the residue;

(e)

to indicate additional components to be analysed for in residue quantification studies (field crop rotation studies);

(f)

to decide on restrictions in crop rotation; and

(g)

to decide on the necessity of field residue trials in rotational crops (limited field studies).

Circumstances in which required U.K.

Metabolism studies in rotational crops shall be provided if the parent compound or soil metabolites are persistent in soil or significant concentrations of metabolites in soil occur.

Rotational crop metabolism studies shall not be required if worst case conditions can be appropriately represented by other available studies in treated crops in accordance with point 6.2.1, where the plant protection product was applied directly to the soil (for example as a pre-planting or pre-emergence application).

Test conditions U.K.

Metabolism studies shall at least involve three crops from three different groups of crops: root and tuber vegetables, leafy vegetables and cereals. Data from further crop groups may be relevant for MRL setting. These crops shall be planted into soil treated at the recommended maximum total application rate for the preceding crops after an appropriate plant-back interval that mimics crop failure early in the vegetation of the crop, crop rotation in the same vegetation period or year and crop rotation in the next vegetation period or year.

6.6.2. Magnitude of residues in rotational crops U.K.

The objectives of studies on residues in rotational crops shall be:

(a)

to permit an evaluation of the magnitude of residues in rotational crops;

(b)

to decide on restrictions in crop rotation;

(c)

to provide information for assessing the overall significance of the residues for dietary risk assessment; and

(d)

to decide on the necessity of MRLs for rotational crops.

Circumstances in which required U.K.

If the metabolism studies indicate that residues of the active substance or of relevant metabolites or breakdown products either from plant or soil metabolism may occur (> 0,01 mg/kg), limited field studies and, if necessary, field trials shall be carried out.

Studies shall not be required in the following cases:

• no metabolism studies on rotational crops are to be performed, or

• metabolism studies on rotational crops show that no residues of concern are to be expected in rotational crops.

Test conditions U.K.

A tiered approach shall be adopted to fulfil the above mentioned objectives. In the first tier, limited field studies at two sites in major growing areas shall be conducted. The plant protection product for which authorisation is sought or a very similar formulation shall be used.

No further studies shall be required where, based on the result from the first tier studies, no detectable residues (< 0,01 mg/kg) in rotational crops are to be expected or if in metabolism studies no residues requiring risk assessment are observed.

For the second tier, additional data shall be submitted to enable appropriate evaluation of dietary risks and establishment of MRLs. These studies shall cover the common crop rotation practice. They shall be performed taking into account the requirements under point 6.3. Trials shall be conducted as closely as possible to agricultural practice on representative crops from major crop groups. At least four trials per crop shall be conducted across the Union in one year. These trials shall be performed in the main production areas across the Union at the highest application rate for the preceding crops. If annual applications of persistent active substances result in higher plateau concentrations in soil than a single application, the plateau concentration shall be taken into account. The necessary residue trials data shall be set up in consultation with the national competent authorities in the Member States.

6.7. Proposed residue definitions and maximum residue levels U.K.

6.7.1. Proposed residue definitions U.K.

The following elements shall be considered when judging which compounds are to be included in the residue definition:

• the toxicological significance of the compounds,

• the amounts likely to be present, and

• the analytical methods proposed for post-approval control and monitoring purposes.

Two different residue definitions may be needed: one for enforcement purposes, based on the marker concept, and one for risk assessment purposes, taking into account toxicologically relevant compounds.

Analytical work in residue trials and feeding studies shall cover all the components of the residue definition for risk assessment.

6.7.2. Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed U.K.

A maximum residue level shall be provided for all products of plant and animal origin covered by Regulation (EC) No 396/2005. In all other cases of products of plant and animal origin used as food or feed and in case of tobacco and medical herbs, a guideline level, that is to say a level derived on the same principles used for MRL setting, shall be provided.

For processed products processing factors shall be provided, unless no processing studies are required.

Furthermore, supervised trials median residue (STMR) and highest residue (HR) values shall be derived and, in cases where processing factors are proposed, STMR-P and HR-P values.

In exceptional cases, when the conditions laid down in Article 16(1) to Regulation (EC) No 396/2005 are met, MRLs may be proposed on the basis of monitoring data. In such cases the proposal shall cover the 95^th percentile of the data population at the 95 % confidence level.

6.7.3. Proposed maximum residue levels (MRLs) and justification of the acceptability of the levels proposed for imported products (import tolerance) U.K.

Point 6.7.2 shall apply to MRLs proposed for imported products (import tolerances).

6.8. Proposed safety intervals U.K.

Safety intervals (that is to say pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses) shall be set taking into account the pest to be controlled and the results from the residue trial data. These intervals shall last at least one day.

6.9. Estimation of the potential and actual exposure through diet and other sources U.K.

When estimating the exposure it shall be born in mind that the risk assessment has to take into account the residue definition established for risk assessment.

Where relevant, the possible presence of pesticide residues arising from sources other than current plant protection uses of active substances (for example use of active substances resulting in common metabolites, use as biocide or veterinary drug), and their aggregate exposure shall be taken into account. In addition, the cumulative exposure to more than one active substance shall, where relevant, be considered.

6.10. Other studies U.K.

6.10.1. Residue level in pollen and bee products U.K.

The objective of these studies shall be to determine the residue in pollen and bee products for human consumption resulting from residues taken up by honeybees from crops at blossom.

The type and conditions of the studies to be performed shall be discussed with the national competent authorities.

(1)

mg/kg bw/day = mg active substance / kg body weight of the concerned species / day.

(2)

Safety intervals refer in this Section to pre-harvest intervals (PHIs), withholding periods or storage periods in the case of post-harvest treatments.