Commission Regulation (EU) No 284/2013Dangos y teitl llawn

3. Good laboratory practice (GLP) U.K.

3.1. Tests and analyses shall be conducted in accordance with the principles laid down in [F1 Annex 1 to] Directive 2004/10/EC of the European Parliament and of the Council(1) where testing is done to obtain data on the properties or safety with respect to human or animal health or the environment. U.K.

Textual Amendments

F1 Words in Annex Introduction point 3.1 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 22(5)(a)(vi); 2020 c. 1, Sch. 5 para. 1(1)

3.2. By way of derogation from point 3.1, tests and analyses, required under the provisions of Sections 6 of Parts A and B, may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the following requirements: U.K.

(a)

they have at their disposal sufficient scientific and technical staff having the necessary education, training, technical knowledge and experience for their assigned functions;

(b)

they have at their disposal suitable equipment required for correct performance of the tests and measurements which they claim to be competent to carry out; that equipment is properly maintained and calibrated, where appropriate, before being put into service and thereafter according to an established programme;

(c)

they have at their disposal appropriate experimental fields and, where necessary glasshouses, growth cabinets or storage rooms; the environment in which the tests are undertaken shall not invalidate their results or adversely effect the required accuracy of measurement;

(d)

they make available to all relevant personnel operating procedures and protocols used for the trials;

(e)

they make available, where requested by the competent authority, prior to the commencement of a test, information on its location and on the tested plant protection products;

(f)

they ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose;

(g)

they maintain records of all observations, calculations and derived data and calibrations records and final test report as long as the product concerned is authorised [F2 by at least one competent authority].

Textual Amendments

F2 Words in Annex Introduction point 3.2(g) substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 22(5)(a)(vii); 2020 c. 1, Sch. 5 para. 1(1)

3.3. Officially recognised testing facilities and organisations, and, where requested by the competent authorities, official facilities and organisations shall: U.K.

• report to the relevant national authority all information necessary to demonstrate that they can satisfy the requirements provided for in point 3.2,

• permit at any time the inspections, which each [F3 competent authority] shall regularly organise on its [F4 constituent] territory in order to verify the compliance with point 3.2.

Textual Amendments

F3 Words in Annex Introduction point 3.3 substituted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 22(5)(a)(viii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Annex Introduction point 3.3 inserted (31.12.2020) by The Plant Protection Products (Miscellaneous Amendments) (EU Exit) Regulations 2019 (S.I. 2019/556), regs. 1(1), 22(5)(a)(viii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

3.4. By way of derogation from point 3.1: U.K.

3.4.1.

For active substances consisting of micro-organisms or viruses, tests and analyses performed to obtain data on their properties and safety with respect to other aspects than human health, may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements specified at points 3.2 and 3.3.

3.4.2.

Studies conducted before the application of this Regulation, although not fully compliant with GLP requirements or with current test methods, may be integrated into the assessment, when accepted by the competent authorities as scientifically valid, thereby removing the need for repeating animal tests, especially for carcinogenicity and reprotoxicity studies. This derogation applies to studies on all vertebrate species.

(1)

OJ L 50, 20.2.2004, p. 44.