Commission Regulation (EU) 2018/782Show full title

I. ELABORATION OF MRLs U.K.

I.1. Derivation of numerical MRLs U.K.

I.1.1. Where it is considered appropriate in accordance with this Regulation to establish numerical MRL values, MRLs shall routinely be recommended for the edible tissues listed below: U.K.

(a)

for mammals other than swine: muscle, fat, liver and kidney;

(b)

for swine and poultry: muscle, fat and skin in natural proportions, liver and kidney;

(c)

for fin-fish: muscle and skin in natural proportions;

(d)

if the substance is proposed for use in a milk producing, egg producing or honey producing species, MRLs shall be recommended for milk, eggs and/or honey, respectively, wherever possible. As for tissues, recommendations for MRLs in milk, eggs and honey shall be based on data demonstrating the residue depletion profile in these commodities. Where no such data are available, it may be considered necessary to reserve an unused portion of the ADI for the future establishment of MRLs in these commodities (Section II.5).

I.1.2. When determining the MRLs, consideration shall be given to the following issues: U.K.

(a)

the ADI (or alternative limit if appropriate) — MRLs shall be recommended at levels that ensure that consumer exposure to residues of concern remains below the ADI;

(b)

the proposed marker residue;

(c)

the ratio of the marker residue to total residues;

(d)

the distribution of residues across edible tissues — the individual MRLs proposed for the different edible tissues shall reflect the distribution of residues across these tissues. In those cases where residues in a tissue rapidly fall below the limit of quantification (the smallest measured content of an analyte above which a determination of the analyte can be made with a specified degree of accuracy and precision) of the analytical method, it shall not be possible to establish MRLs that reflect the distribution of residues across tissues. Where this occurs, MRLs shall be set at twice the limit of quantification in order to provide an MRL for use in residue surveillance. Wherever possible, the tissue selected for residue monitoring purposes shall be one in which the MRL was set taking the distribution of residues across tissues into account;

(e)

the overall exposure of the consumer to residues — this shall be demonstrated to be below the ADI based on the residue levels seen in the depletion studies, and using the standard food basket (see below).

I.1.3. In deriving MRLs it shall be assumed that the consumer will eat a standard food basket of animal-derived products every day. Consumer safety shall be ensured by keeping the total amount of residues in the standard food basket below the ADI. U.K.

The standard food basket shall be made up of the quantities of the food commodities shown in the table below:

a Fat and skin in natural proportions for pigs
Mammals		Poultry		Fish		Bees
Muscle	0,300 kg	Muscle	0,300 kg	Muscle and skin in natural proportions	0,300 kg	Honey	0,020 kg
Fat	0,050 kga	Fat and skin in natural proportions	0,090 kg
Liver	0,100 kg	Liver	0,100 kg
Kidney	0,050 kg	Kidney	0,010 kg
Milk	1,500 kg	Eggs	0,100 kg

I.1.4. Using the residue depletion data, the total residue burden in the standard food basket shall be calculated based on the observed residue levels at each time point on the residue depletion curve, so that the time point at which the total residue burden falls below the ADI is established. If the full ADI is available then these residue levels, rounded up as appropriate (usually to the nearest 50 μg/kg for tissues), shall be considered as potential MRLs. Consideration shall also be given to the factors listed under Section II points 1 to 7 and, if appropriate (e.g. if less than the full ADI is available), a subsequent time point on the residue depletion curve shall be used as the point from which to derive the MRLs. U.K.

I.1.5. Once MRL levels have been derived, the Theoretical Maximum Daily Intake (‘TMDI’) of residues shall be calculated using the standard food basket and assuming that residues are present in all food commodities at the level of the proposed MRLs. The TMDI is calculated by adding exposure to residues from all tissues obtained using the following calculation: U.K.

Amount per edible tissue or product = (proposed MRL for the tissue or product x (times) daily consumption of the tissue or product)/(divided by) Ratio of the marker to total residue in the tissue or product.

I.2. The ‘No MRL required’ classification U.K.

I.2.1. A ‘No MRL required’ classification may be recommended in those cases where it is clear that the establishment of numerical MRLs is not necessary for the protection of the consumer. The consumer exposure to residues shall always remain at safe levels (below the ADI or alternative limit) in order for a ‘No MRL required’ classification to be recommended. U.K.

I.2.2. Substances may be regarded as candidates for a ‘No MRL required’ status, if they fulfil one or more of the criteria stated below. It shall be noted, however, that fulfilment of one or more of these criteria shall not be regarded as automatically implying that a ‘No MRL required’ status shall be recommended. The following specificities of each individual substance shall be fully evaluated before reaching a conclusion: U.K.

(a)

substances of endogenous origin, particularly if exposure to residues has only a minor impact on the overall exposure to the substance;

(b)

substances which are essential nutrients or normal constituents of the diet in man and animals;

(c)

substances for which no pharmacological activity considered to be biologically relevant has been identified;

(d)

substances that have been demonstrated to be of low toxicity following exposure by the oral route;

(e)

substances that are not absorbed or are poorly absorbed from the gastro-intestinal tract or from the sites of local application (e.g. skin or eyes);

(f)

substances that are rapidly and extensively detoxified or excreted;

(g)

substances that have been demonstrated not to result in detectable residues in food derived from treated animals.

I.2.3. In some cases a ‘No MRL required’ recommendation may incorporate a restriction on the way the substance is to be used (for example, a restriction ‘for cutaneous use only’ may be recommended in cases where it is clear that no residues of concern will result following cutaneous use, but the possibility of harmful residues cannot be ruled out following administration of the substance by a different route). U.K.