(1)

Where necessary for the purpose of official controls of food of animal origin, the Commission may establish reference values (‘reference points for action’) for residues of pharmacologically active substances in food of animal origin, for which no maximum residue limit has been laid down. Reference points for action should apply to food of animal origin imported from third countries and to food of animal origin produced in the Union.

(2)

Following a request from the Commission, the EFSA Panel on Contaminants in the Food Chain (EFSA CONTAM Panel) has adopted guidance on methodological principles and scientific methods to be taken into account when assessing the safety of reference points for action (‘EFSA guidance’) (2). EFSA guidance describes a process for assessing whether the analytical concentration of a pharmacologically active substance, which can be determined by official control laboratories using a validated analytical method, is low enough to adequately protect human health.

(3)

EFSA guidance further specifies situations, in which a substance-specific risk assessment should be undertaken by EFSA in accordance with Regulation (EC) No 470/2009. In particular, in order to ensure an adequate level of health protection, substance-specific risk assessments should be performed for pharmacologically active substances, which cause blood dyscrasias (aplastic anaemia) or allergy (excluding skin sensitisation) or which are high potency carcinogens or inorganic substances.

(4)

Methodological principles and scientific methods for assessing the safety of reference points for action should therefore be adopted.

(5)

Commission Decision 2002/657/EC (3) lays down the minimum required performance limits of analytical methods used for detecting a limited number of substances, for which the use is not allowed, or is specifically prohibited in the Union. Those minimum required performance limits correspond to the average limit above which the detection of a substance or its residues can be considered as methodologically meaningful. The minimum required performance limits apply to the matrixes specified in Annex II to that Decision.

(6)

Pursuant to Commission Decision 2005/34/EC (4), the minimum required performance limits laid down in Decision 2002/657/EC are to be used as reference points for action irrespective of the food matrix tested for food of animal origin, imported from third countries. Food of animal origin, containing residues of a pharmacologically active substance in a concentration at or above the reference point for action, is to be considered not to comply with Union legislation, while food of animal origin containing concentrations below the reference points for action are not to be prohibited from entering the food chain. However, the setting of reference points for action should in no way serve as a pretext for condoning the illegal use of prohibited or non-allowed substances. Therefore any residues of those substances in food of animal origin should be considered undesirable. The reference points for action laid down in Decision 2005/34/EC have been based solely on analytical considerations, taking into account the lowest residue concentration, which can be detected and confirmed with a validated analytical method, without consideration of the toxic potential of the substances in question.

(7)

For chloramphenicol, malachite green and nitrofuran metabolites reference points for action have been laid down in Decision 2005/34/EC. For these substances, however, EFSA concluded that following EFSA guidance instead of the standard risk assessment methodology a substance-specific risk assessment was needed. Therefore, following the request of the Commission, the EFSA CONTAM Panel adopted scientific opinions on chloramphenicol in food and feed (5), on nitrofurans and their metabolites in food (6) and on malachite green in food (7).

(8)

It is therefore appropriate to lay down reference points for action for these substances, which take into account both the analytical considerations and the toxic potential of these substances. In view of the uncertainties, which EFSA identified in its risk assessments for chloramphenicol and the nitrofuran metabolites, the sensitivity of analytical methods should be improved, in order to enable enforcement of the lowest possible concentrations.

(9)

Detection of residues of prohibited or non-allowed substances, even below established reference points for action, could be a signal of misuse of such substances. In such cases Regulation (EC) No 470/2009 requires Member States and, as appropriate, the Commission, to take follow-up measures. To this end, information should be available to the Member States and the Commission through the Rapid Alert System for Food and Feed (8).

(10)

In order to allow official laboratories to adapt their methods to the updated reference points for action for chloramphenicol, malachite green and nitrofuran metabolites, a period of three years should be allowed to elapse before these lowered reference points for action become applicable.

(11)

As this Regulation takes over the provisions of Decision 2005/34/EC, updates and further expands them, for reasons of legal certainty Decision 2005/34/EC should be repealed.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(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.