Commission Regulation (EU) 2019/1871 of 7 November 2019 on reference points for action for non-allowed pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC (Text with EEA relevance)

• CELEX: Regulation (EU) 2019/1871
• Articles: 10

Article 1 Scope

This Regulation lays down:

(a)

rules for the establishment of reference points for action for residues of pharmacologically actives substances, for which no maximum residue limit has been laid down in accordance with Regulation (EC) No 470/2009;

(b)

methodological principles and scientific methods for the risk assessment of the safety of reference points for action;

(c)

reference points for action for residues from certain pharmacologically active substances for which no maximum residue limit has been laid down in accordance with Regulation (EC) No 470/2009;

(d)

specific rules on action to be taken in the case of a confirmed presence of a residue of a prohibited or non-allowed substance at levels above, equal to or below the reference point for action.

Article 2 Rules for the establishment of reference points for action

Reference points for action shall be set at the lowest level which can analytically be achieved by the official control laboratories, designated in accordance with Article 37 of Regulation (EU) 2017/625 of the European Parliament and of the Council  ( 9 ) .

Reference points for action shall be regularly reviewed to ensure that they correspond to the lowest levels, which are achievable, taking into account the most recent scientific developments.

When setting or reviewing reference points for action, the Commission shall consult the relevant European Reference Laboratories on the analytical capabilities of National Reference Laboratories and official laboratories, as regards the lowest residue concentration, which can be identified with an analytical method, validated in accordance with the requirements of Decision 2002/657/EC.

Article 3 Methodological principles and scientific methods of risk assessment

1.   The risk assessment applied for the assessment of the safety of reference points for action shall take into account:

(a)

the toxic potential and pharmacological activity of the substance;

(b)

intake of the residue via food.

2.   For the purpose of determining the toxic potential and pharmacological activity of the substance, the following toxicological screening values shall be applied:

(a)

for Group I substances, corresponding to non-allowed pharmacologically active substances for which there is direct evidence of genotoxicity or for which there is an alert for genotoxicity (from structure activity relationships or read across) or for which there is a lack of information on genotoxicity, and hence genotoxicity cannot be excluded 0,0025 μg/kg body weight (b.w.) per day;

(b)

for Group II substances, corresponding to non-allowed pharmacologically active substances with pharmacological activity on the nervous system or the reproductive system, or that are corticoids 0,0042 µg/kg b.w. per day;

(c)

for Group III substances, corresponding to non-allowed pharmacologically active substances with anti-infectious, anti-inflammatory and antiparasitic effect and other pharmacologically active agents 0,22 µg/kg b.w. per day.

3.   The relevant food intake shall be determined based on food consumption figures, food consumption patterns and the occurrence of the substance in different food commodities.

4.   The safety of reference points for action shall be assessed, by verifying whether the toxicological screening value, divided by the relevant food intake, is higher than or equal to the analytical capability of the official control laboratories, in which case the safety of the reference point for action at the analytical capability level is guaranteed.

Article 4 Substance-specific risk assessment

1.   A request shall be addressed to EFSA for a substance-specific risk assessment as to whether reference points for action are adequate to protect human health, in particular for substances:

(a)

that cause blood dyscrasias or allergy (excluding skin sensitisation);

(b)

that are high potency carcinogens;

(c)

for which genotoxicity cannot be excluded, if there is experimental or other evidence that the use of the toxicological screening value of 0,0025 μg/kg b.w. per day may not be adequately health protective.

2.   The Commission shall, where appropriate, submit a request to EFSA for a substance-specific risk assessment as to whether a reference point for action is adequate to protect human health, where application of the method laid down in Article 3(4) indicates that the toxicological screening value, divided by the relevant food intake, is lower than the analytical capability of the official control laboratories, and that there is little or no possibility of significant improvement in the analytical capability within a short to medium time frame.

3.   Where the substance specific risk assessment is inconclusive, due to uncertainties regarding certain aspects of the toxicological or exposure assessment, and no guarantees are available on whether the lowest analytically achievable concentration is sufficiently safe for consumers, the European and National Reference Laboratories shall endeavour to improve the sensitivity of analytical methods in order to be able to enforce lower concentrations and the reference points for action shall be set at levels which are low enough to stimulate improvement of the lowest achievable levels.

Article 5 Enforcement of reference points for action

For the purpose of control in food of animal origin of some residues of substances, whose use is prohibited or not allowed in the Union, the reference points for action, laid down in the Annex, shall apply irrespective of the food matrix tested.

Food of animal origin, containing residues of a pharmacologically active substance in a concentration at or above the reference point for action, shall be considered not to comply with Union legislation and shall not enter the food chain. Food of animal origin containing residues of a pharmacologically active substance in a concentration at a level below the reference point for action shall not be prohibited from entering the food chain.

Article 6 Information exchange and investigations in case of confirmed presence of a prohibited or non-allowed substance

Where the results of official controls, including analytical tests, identify residues of prohibited or non-allowed substances at levels above, equal to or below the reference points for action, the competent authority shall carry out the investigations referred to in Articles 137(2) or (3) of Regulation (EU) 2017/625 and Articles 13, 16(2), 17 and 22 to 24 of Directive 96/23/EC  ( 10 ) , to determine whether there has been illegal treatment with a prohibited or non-allowed pharmacologically active substance.

In the event of established non-compliance, the competent authority shall take one or more actions referred to in Article 138 of Regulation (EU) 2017/625 and Articles 15(3), 17 and 23 to 25 of Directive 96/23/EC.

The competent authority shall retain a record of the findings. Where the results of official controls, including analytical tests on foods of animal origin from the same operator, show a recurrent pattern pointing to suspicion of non-compliance related to one or several prohibited or non-allowed substances from a particular origin, the competent authority shall inform the Commission and the other Member States in the Standing Committee on Plants, Animals, Food and Feed.

Where the recurrent pattern concerns imported food, the Commission shall bring this to the attention of the competent authority of the country or countries of origin.

Member States shall report the results of official controls, including analytical tests, showing confirmed presence of a prohibited or non-allowed substance at levels above or equal to the reference points for action through the Rapid Alert System for Food and Feed.

Article 7 Repeal of Decision 2005/34/EC

Decision 2005/34/EC is repealed.

Article 8 Application of the reference points for action

The reference points for action, set out in the Annex to this Regulation shall apply from 28 November 2022.

Until the date laid down in the first paragraph the minimum required performance limits for chloramphenicol, nitrofuran metabolites and the sum of malachite green and leucomalachite green, included in Annex II to Decision 2002/657/EC, shall apply as reference points for action for food of animal origin imported from third countries and for food of animal origin produced in the Union.

Article 9 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

Reference points for action (RPA)

Substance

RPA

(µg/kg)

Other provisions

Chloramphenicol

0,15

Malachite green

0,5

0,5 µg/kg for the sum of malachite green and leucomalachite green

Nitrofurans and their metabolites

0,5  ( 1 )

0,5 µg/kg for each of the metabolites of furazolidone (AOZ or 3-amino-2-oxazolidinone), furaltadone (AMOZ or 3-amino-5-methylmorpholino-2-oxazolidinone), nitrofurantoin (AHD or 1-aminohydantoin), nitrofurazone (SEM or semicarbazide) and nifursol (DNSH or 3,5-dinitrosalicylic acid hydrazide)

( 1 )   Due to the natural occurrence of SEM in crayfish at levels above the RPA, only levels of AOZ, AMOZ, AHD and DNSH above the RPA are a clear indication of the illegal use of nitrofurans and their metabolites. The RPA of 0,5 µg/kg for SEM in crayfish shall only be applied, when the illegal use of nitrofurazone on crayfish has been established.