Commission Regulation (EU) No 546/2011Show full title

2.6.2. Effects on human or animal health arising from residues U.K.

In the evaluation, non-viable and viable residues must be addressed separately. Viruses and viroids should be considered as viable residues since they are capable of transferring genetic material, although strictly speaking they are not living.

2.6.2.1. Non-viable residues U.K.

(a) [F1 Competent authorities] shall evaluate the possibility of exposure of humans or animals to non-viable residues and their degradation products via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account: U.K.

• the stage of development of the micro-organism at which non-viable residues are produced,

• the development stages/life cycle of the micro-organism under typical environmental conditions; in particular, attention shall be paid to the assessment of the likelihood of survival and multiplication of the micro-organism in or on crops, food or feed, and, as a consequence, the likelihood of the production of non-viable residues,

• the stability of relevant non-viable residues (including the effects of factors such as temperature, UV light, pH and the presence of certain substances),

• any experimental study showing whether or not relevant non-viable residues are translocated in plants,

• data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods, in the case of post-harvest uses) and additional data on application as provided for in part B of the Annex to Regulation (EU) No 545/2011,

• where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same residues, and

• the natural occurrence of non-viable residues on edible plant parts as a consequence of naturally occurring micro-organisms.

Textual Amendments

F1 Words in Annex Pt. 2.B points 2.6.2.1, 2.6.2.2 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(b)(xviii); 2020 c. 1, Sch. 5 para. 1(1)

(b) [F1 Competent authorities] shall evaluate the toxicity of non-viable residues and their degradation products having regard in particular to the specific information provided in accordance with part B of the Annex to Regulation (EU) No 544/2011 and in part B of the Annex to Regulation (EU) No 545/2011. U.K.

(c) Where non-viable residues or their degradation products are considered toxicologically relevant for humans and/or animals and when exposure is not considered negligible, the actual levels in or on the edible parts of treated crops shall be determined, taking into consideration: U.K.

• analytical methods for the non-viable residues,

• the growth curves of the micro-organism under optimal conditions,

• the production/formation of non-viable residues at relevant moments (e.g. at the anticipated harvest time).

2.6.2.2. Viable residues U.K.

(a) [F1 Competent authorities] shall evaluate the possibility of exposure of humans or animals to viable residues via the food chain due to the possible occurrence of such residues in or on edible parts of treated crops. In particular, the following information should be taken into account: U.K.

• the likelihood of survival, the persistence and multiplication of the micro-organism in or on crops, food or feed. The various development stages/life cycle of the micro-organism shall be addressed,

• information concerning its ecological niche,

• information on fate and behaviour in the various parts of the environment,

• the natural occurrence of the micro-organism (and/or a related micro-organism),

• data concerning the proposed good agricultural practice (including number and timing of applications, maximum application rate and minimum spray application volume, proposed pre-harvest intervals for envisaged uses, or withholding periods or storage periods in the case of post-harvest uses) and additional data on application as provided for in part B of the Annex to Regulation (EU) No 545/2011,

• where relevant, other authorised uses of plant protection products in the area of envisaged use, i.e. containing the same micro-organism or which result in the same residues.

(b) [F1 Competent authorities] shall evaluate the specific information concerning the ability of viable residues to persist or grow in the host and the ability of such residues to cause effects/reactions in the host. In particular, the following information shall be taken into account: U.K.

• the medical data and toxicity, infectivity and pathogenicity studies provided for in part B of the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof,

• the development stages/life cycle of the micro-organism under typical environmental conditions (e.g. in or on the treated crop),

• the mode of action of the micro-organism,

• the biological properties of the micro-organism (e.g. host specificity).

The various development stages/life cycle of the micro-organism shall be addressed.

(c) In the event that viable residues are considered to be toxicologically relevant for humans and/or animals and if exposure is not considered negligible, the actual levels in or on the edible parts of treated crops shall be determined, taking into consideration: U.K.

• analytical methods for the viable residues,

• the growth curves of the micro-organism under optimal conditions,

• the possibilities of extrapolating data from one crop to another.