Commission Delegated Regulation (EU) 2021/1353 of 17 May 2021 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to the cases and conditions under which competent authorities may designate official laboratories which do not fulfil the conditions in relation to all the methods they use for official controls or other official activities (Text with EEA relevance)

• CELEX: Delegated Regulation (EU) 2021/1353
• Articles: 5

Article 1 Subject matter

This Regulation establishes the cases where, and the conditions under which, laboratories which do not fulfil the conditions of accreditation laid down in Article 37(4), point (e) of Regulation (EU) 2017/625 in relation to all the methods they use for official controls or other official activities may be designated as official laboratories by the competent authorities.

Article 2 Official laboratories in the areas of food contact materials, food additives, food enzymes, flavourings and feed additives

The competent authorities may designate laboratories which do not fulfil the conditions referred to in Article 37(4), point (e) of Regulation (EU) 2017/625 in relation to all the methods of laboratory analysis, test or diagnosis they use for official controls or other official activities, as official laboratories in the areas of food contact materials, food additives, food enzymes, flavourings and feed additives provided that:

(a)

those laboratories have a quality assurance system in place to ensure that reliable results are obtained from the use of methods of laboratory analysis, test or diagnosis outside the scope of their accreditation and

(b)

the non-accredited methods used by those laboratories are characterised by the relevant criteria to the areas covered under this article set out in Annex III to Regulation (EU) 2017/625.

Article 3 Official laboratories in the areas of plant health

The competent authorities may designate laboratories which do not fulfil the conditions referred to in Article 37(4), point (e) of Regulation (EU) 2017/625 in relation to all the methods of laboratory analysis, test or diagnosis they use for official controls or other official activities, as official laboratories in the areas of plant health provided that:

(a)

those laboratories have a quality assurance system in place to ensure that reliable results are obtained from the use of methods of laboratory analysis, test or diagnosis outside the scope of their accreditation;

(b)

the non-accredited methods used by those laboratories are characterised by the relevant criteria to the area of plant health set out in Annex III to Regulation (EU) 2017/625, and

(c)

the laboratory is already accredited for at least one of the methods listed in the categories referred to in the Annex for use on a pest from the same organism group as the pest for which the non-accredited method is used.

Article 4 Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

Article 3 shall apply from 29 April 2022.

Schedules & Appendices

ANNEX CATEGORIES OF METHODS USED FOR ANALYSES, TESTS AND DIAGNOSES IN THE AREA OF PLANT HEALTH

ANNEX

CATEGORIES OF METHODS USED FOR ANALYSES, TESTS AND DIAGNOSES IN THE AREA OF PLANT HEALTH

1.

Baiting, isolation and extraction methods, including:

—

Plating methods

—

Methods for extraction of target organism from matrix

2.

Morphological and morphometric methods

3.

Pathogenicity assessment methods

4.

Biochemical methods, including:

—

Enzyme electrophoresis

—

Return-Polyacrylamide Gel Electrophoresis (R-PAGE)

5.

Fingerprint methods, including:

—

Protein profiling

—

Fatty acid profiling

—

DNA profiling

—

MALDI-TOF mass spectrometry

6.

Molecular methods, including:

—

Conventional Polymerase Chain Reaction (PCR)

—

Real-time Polymerase Chain Reaction (Real Time PCR)

—

Loop-mediated isothermal amplification (LAMP)

—

Recombinase polymerase amplification (RPA)

—

Next-generation sequencing (NGS)

—

DNA barcoding

7.

Serological methods, including:

—

Immunofluorescence

—

Enzyme-linked immunosorbent assay (ELISA)

—

Immunosorbent electron microscopy