INHALT

Commission Regulation (EU) 2018/782 of 29 May 2018 establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009 (Text with EEA relevance. )

COMMISSION REGULATION (EU) 2018/782
of 29 May 2018
establishing the methodological principles for the risk assessment and risk management recommendations referred to in Regulation (EC) No 470/2009
(Text with EEA relevance)
Article 1
Subject matter
Article 2
Definitions
Article 3
Entry into force
ANNEX I
Methodological principles for the scientific risk assessment referred to in Article 6 of Regulation (EC) No 470/2009
I. GENERAL PRINCIPLES
II. SAFETY FILE
II.4.
Detailed and critical summary
II.5.
Precise identification of the substance concerned by the application
II.6.
Pharmacology
II.6.1.
Pharmacodynamics
II.6.2.
Pharmacokinetics
II.6.3.
Toxicology
II.6.3.1.
General principles
II.6.3.2.
Single-dose toxicity, if available
II.6.3.3.
Repeat dose toxicity
II.6.3.3.1.
Repeat dose (90 day) oral toxicity testing
II.6.3.3.2.
Repeat-dose (chronic) toxicity testing
II.6.3.4.
Tolerance in target species, if available
II.6.3.5.
Reproductive toxicity, including developmental toxicity
II.6.3.5.1.
Study of the effects on reproduction
II.6.3.5.2.
Study of developmental toxicity
II.6.3.6.
Genotoxicity
II.6.3.7.
Carcinogenicity
II.6.3.7.1.
Criteria for the selection of substances for carcinogenicity testing
II.6.4.
Other requirements
II.6.4.1.
General principles
II.6.4.2.
Special studies (e.g. immunotoxicity, neurotoxicity)
II.6.4.2.1
Immunotoxicity
II.6.4.2.2.
Neurotoxicity, developmental neurotoxicity and delayed neurotoxicity
II.6.4.3.
Microbiological properties of residues
II.6.4.3.1.
Potential effects on the human gut flora
II.6.4.4.
Observations in humans
II.6.5.
Findings of other EU or international scientific bodies
II.6.6.
Determination of an ADI or alternative limit
II.6.6.1.
Determination of an ADI
II.6.6.1.1.
Derivation of the toxicological ADI
II.6.6.1.2.
Derivation of the pharmacological ADI
II.6.6.1.3.
Derivation of a microbiological ADI
II.6.6.1.4.
The overall ADI
II.6.6.1.5.
Substances with non-threshold effects
II.6.6.2.
Alternatives to the ADI
II.6.6.2.1.
Substances for which recommended dietary intake levels have been established
II.6.6.2.2.
Substances to which consumers are exposed via food or other sources and for which recommended intake levels have not been established
II.6.6.2.3.
Endogenous pharmacologically active substances
II.6.6.2.4.
Substances that lack bioavailability
III. RESIDUE FILE
III.2.
Detailed and critical summary
III.3.
Metabolism and residue kinetics in the target species
III.4.
Monitoring and exposure data, if relevant
III.5.
Residue analytical method
III.6.
Potential effects on the microorganisms used for industrial food processing
III.7.
Findings of other EU or international scientific bodies
ANNEX II
Methodological principles for the risk management recommendations referred to in Article 7 of Regulation (EC) No 470/2009
I. ELABORATION OF MRLs
I.1.
Derivation of numerical MRLs
I.2.
The ‘No MRL required’ classification
II. AVAILABILITY OF ALTERNATIVE MEDICINES AND OTHER LEGITIMATE FACTORS
II.1.
Availability of alternative medicines
II.2.
Technological aspects of food and feed productions
II.3.
Feasibility of controls
II.4.
Conditions of use and application of the substances in veterinary medicinal products, good practice in the use of veterinary medicinal products and biocidal products, the likelihood of misuse or illegal use and other relevant factors
II.5.
Need for an unused portion of the ADI
II.6.
Exposure from other sources (combined exposure to dual-use substances)
II.7.
Injection site residues
III. CONSIDERATIONS ON POSSIBLE EXTRAPOLATION OF MRLs