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

A. INTRODUCTION U.K.

1. The principles developed in Part II aim to ensure that evaluations and decisions with regard to authorisation of plant protection products, provided they are microbial plant protection products, result in the implementation of the requirements of Article 29(1)(e) in conjunction with Article 4(3) and Article 29(f), (g) and (h) of Regulation (EC) No 1107/2009 by all [F1 competent authorities] at a high level of protection of human and animal health and the environment. U.K.

Textual Amendments

F1 Words in Annex Pt. 2.A points 1, 2, 4 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

2. In evaluating applications for granting authorisations [F1 competent authorities] shall: U.K.

(a)

• ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of part B of the Annex to Regulation (EU) No 545/2011, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to Articles 33, 34 and 59 of Regulation (EC) No 1107/2009,

• ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,

• evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;

(b)

take into account the data referred to in part B of the Annex to Regulation (EU) No 544/2011, concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of approval of the micro-organism concerned as active substances under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to Article 33(3) and Articles 34 and 59 of Regulation (EC) No 1107/2009;

(c)

take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins.

3. Where, in the specific principles on evaluation, reference is made to the data of part B of the Annex to Regulation (EU) No 544/2011 this shall be understood as being the data referred to in point 2(b). U.K.

4. Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use. U.K.

Taking account of justifications provided and with the benefit of any subsequent clarifications, [F1 competent authorities] shall reject applications for granting authorisations for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses.

5. During the process of evaluation and decision-making, the [F2 competent authority] shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of Regulation (EC) No 1107/2009. U.K.

Textual Amendments

F2 Words in Annex Pt. 2.A point 5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

[F3 Competent authorities] shall normally come to a reasoned decision within 12 months of receiving a technically complete dossier. A technically complete dossier is one that satisfies all the requirements of part B of the Annex to Regulation (EU) No 545/2011.

Textual Amendments

F3 Words in Annex Pt. 2.A point 5 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

6. The judgements made by the competent authorities F4 ... during the evaluation and decision-making process must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice. U.K.

Textual Amendments

F4 Words in Annex Pt. 2.A point 6 omitted (31.12.2020) by virtue of The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

7. A microbial plant protection product may contain viable and non-viable micro-organisms (including viruses) and formulation substances. It may also contain relevant metabolites/toxins produced during growth, residues from the growth medium, and microbial contaminants. The micro-organism, relevant metabolites/toxins and the plant protection product with residual growth medium and microbial contaminants present must all be evaluated. U.K.

8. [F5 Competent authorities] must take into account those guidance documents [F6 issued in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council or Regulation (EC) No 1107/2009 of the European Parliament and of the Council]. U.K.

Textual Amendments

F5 Words in Annex Pt. 2.A point 8 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(iv)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Annex Pt. 2.A point 8 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(iv)(bb); 2020 c. 1, Sch. 5 para. 1(1)

9. For genetically modified micro-organisms, [F7 the EU-derived domestic legislation which transposed] Directive 2001/18/EC of the European Parliament and of the Council(1), must be taken into account. The evaluation completed in the framework of that [F8 legislation] must be provided and taken into account. U.K.

Textual Amendments

F7 Words in Annex Pt. 2.A point 9 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(v)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Annex Pt. 2.A point 9 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 18(9)(a)(v)(bb); 2020 c. 1, Sch. 5 para. 1(1)

10. Definitions and explanations of microbiological terms U.K.

Antibiosis

:

A relationship between two or more species in which one species is actively harmed (as by the production of toxins by the harming species).

Antigenic

:

Any substance that, as a result of coming in contact with appropriate cells, induces a state of sensitivity and/or immune responsiveness after a latent period (days to weeks) and which reacts in a demonstrable way with antibodies and/or immune cells of the sensitised subject in vivo or in vitro.

Antimicrobial

:

Antimicrobial agents or antimicrobial(s) refer to naturally occurring, semi-synthetic or synthetic substances that exhibit antimicrobial activity (kill or inhibit the growth of micro-organisms).

The term antimicrobial(s) includes:

• antibiotics, which refer to substances produced by or derived from micro-organisms, and

• anticoccidials, which refer to substances that are active against coccidia, single cell protozoan parasites.

CFU

:

Colony-forming unit; one or more cells that grow to form a single visible colony.

Colonisation

:

Proliferation and persistence of a micro-organism in an environment, such as on external (skin) or internal body surfaces (intestine, lungs). For colonisation, the micro-organism must at least persist for a longer period than expected in a specific organ. The population of micro-organisms may decline but at a slower rate than normal clearance; it may be a steady population or it may be a growing population. Colonisation can be related to harmless and functional micro-organisms as well as to pathogenic micro-organisms. The possible occurrence of effects is not indicated.

Ecological niche

:

Unique environmental position occupied by a particular species, perceived in terms of actual physical space occupied and function performed within the community or ecosystem.

Host

:

An animal (including humans) or plant that harbours or nourishes another organism (parasite).

Host specificity

:

The range of different host-species that can be colonised by a microbial species or strain. A host-specific micro-organism colonises or has adverse effects on one or only a small number of different host-species. A non-host-specific micro-organism might colonise or might have adverse effects on a broad range of different host-species.

Infection

:

The introduction or entry of a pathogenic micro-organism into a susceptible host, whether or not it causes pathological effects or disease. The organism must enter the body of the host, usually the cells, and be able to reproduce to form new infective units. Simply ingesting a pathogen does not imply infection.

Infective

:

Capable of transmitting an infection.

Infectivity

:

The characteristics of a micro-organism that allow it to infect a susceptible host.

Invasion

:

The entry of a micro-organism into the host body (e.g. actual penetration of the integument, gut epithelial cells, etc.). ‘Primary invasiveness’ is a property of pathogenic micro-organisms.

Multiplication

:

Ability of a micro-organism to reproduce and increase in numbers during an infection.

Mycotoxin

:

A fungal toxin.

Non-viable micro-organism

:

A micro-organism that is not capable of replication or of transferring genetic material.

Non-viable residue

:

A residue that is not capable of replication or of transferring genetic material.

Pathogenicity

:

The ability of a micro-organism to cause disease and/or inflict damage on the host. Many pathogens cause disease by a combination of (i) toxicity and invasiveness or (ii) toxicity and colonising ability. However, some invasive pathogens cause disease that results from an abnormal reaction of the host’s defence system.

Symbiosis

:

A type of interaction between organisms where one organism lives in intimate association with another, which is favourable for both organisms.

Viable micro-organism

:

A micro-organism that is capable of replication or of transferring genetic material.

Viable residue

:

A residue that is capable of replication or of transferring genetic material.

Viroid

:

Any of a class of infectious agents consisting of a small strand of RNA not associated with any protein. The RNA does not code for proteins and is not translated; it is replicated by host cell enzymes. Viroids are known to cause several plant diseases.

Virulence

:

Measurement of the degree of disease producing ability of a micro-organism as indicated by the severity of the disease produced. Measure of the dosage (inoculum size) required to cause a specific degree of pathogenicity. It is measured experimentally by the median lethal dose (LD₅₀) or median infective dose (ID₅₀).

(1)

OJ L 106, 17.4.2001, p. 1.