TITLE IIIU.K.REFERENCE LABORATORIES AND REFERENCE CENTRES

F1Article 92U.K.Decision to establish a European Union reference laboratory

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F1Article 93U.K.Designation of European Union reference laboratories

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F1Article 94U.K.Responsibilities and tasks of European Union reference laboratories

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Article 95U.K.Designation of [F2national] reference centres for animal welfare

1.The [F3appropriate authority must make regulations designating national reference centres for animal welfare to support activities] in relation to the application of the rules referred to in point (f) of Article 1(2).

2.The designations provided for in paragraph 1 shall:

(a)follow a public selection process; and

(b)be limited in time or reviewed regularly.

3.[F4National] reference centres for animal welfare shall:

(a)act impartially as regards the exercise of their tasks as [F5national] reference centres;

(b)possess a high level of scientific and technical expertise in human-animal relationship, animal behaviour, animal physiology, animal genetics, animal health and nutrition related to animal welfare, and animal welfare aspects related to the commercial and scientific use of animals;

(c)have suitably qualified staff with adequate training in the areas referred to in point (b) and in ethical issues related to animals and support staff as appropriate;

(d)possess, or have access to, the infrastructure, the equipment and products necessary to carry out the tasks assigned to them; and

(e)ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest developments in research at nationalF6... and international level, including studies performed and actions undertaken by other F7... reference centres for animal welfare, in those areas are taken into account in their work.

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Article 96U.K.Responsibilities and tasks of [F2national] reference centres for animal welfare

The [F8national] reference centres for animal welfare shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmesF9...:

(a)

providing scientific and technical expertise within the scope of their mission including, where appropriate in the form of coordinated assistance, to relevant national support networks and bodies in the area governed by the rules referred to in point (f) of Article 1(2);

(b)

providing scientific and technical expertise for the development and application of the animal welfare indicators referred to in point (e) of Article 21(8);

(c)

developing or coordinating the development of methods for the assessment of the level of welfare of animals and of methods for the improvement of the welfare of animals;

(d)

carrying out scientific and technical studies on the welfare of animals used for commercial or scientific purposes;

(e)

conducting training courses for staff of the national scientific support networks or bodies referred to in point (a), for staff of the competent authorities and for experts from third countries; and

(f)

disseminating research findings and technical innovations and collaborating with [F10other] research bodies in the fields within the scope of their mission.

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Article 97U.K.Designation of [F2national] reference centres for the authenticity and integrity of the agri-food chain

[F111.The competent authority may designate national reference centres to support the activities of the competent authorities in preventing, detecting and combating violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices.]

2.The designations provided for in paragraph 1 shall:

(a)follow a public selection process; and

(b)be limited in time or reviewed regularly.

3.[F12National] reference centres for the authenticity and integrity of the agri-food chain shall:

(a)act impartially as regards the exercise of their tasks as [F13national] reference centres;

(b)possess a high level of scientific and technical expertise in the areas governed by the rules referred to in Article 1(2) and in applied forensic science in those areas, in order to have the ability to carry out or coordinate research at the highest level on the authenticity and integrity of goods and to develop, apply and validate the methods to be used for the detection of violations of the rules referred to in Article 1(2) perpetrated through fraudulent or deceptive practices;

(c)have suitably qualified staff with adequate training in the areas referred to in point (b) and the necessary support staff;

(d)possess, or have access to, the infrastructure, the equipment and the products necessary to carry out the tasks assigned to them; and

(e)ensure that their staff have good knowledge of international standards and practices in the areas referred to in point (b) and that the latest research developments at national F14... and international level in those areas are taken into account in their work.

Textual Amendments

Article 98U.K.Responsibilities and tasks of [F2national] reference centres for the authenticity and integrity of the agri-food chain

The [F15national] reference centres for the authenticity and integrity of the agri-food chain shall be responsible for the following supporting tasks insofar as they are included in the reference centres’ annual or multiannual work programmesF16...:

(a)

providing specialised knowledge in relation to the authenticity and integrity of the agri-food chain and to the methods for detecting violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices, in relation to the forensic science applied to the areas governed by these rules;

(b)

providing specific analyses designed to identify the segments of the agri-food chain that are potentially subject to violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices and helping to develop specific official control techniques and protocols;

(c)

F17...

(d)

where necessary, establishing and maintaining collections or databases of authenticated reference materials, to be used to detect violations of the rules referred to in Article 1(2) of this Regulation perpetrated through fraudulent or deceptive practices; and

(e)

disseminating research findings and technical innovations in the fields within the scope of their mission.

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Article 99U.K.Obligations of the [F18appropriate authority]

1.The [F19appropriate authority] shall publish and update, whenever necessary, the list of:

F20(a). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b)[F21national] reference centres for animal welfare provided for in Article 95;

(c)[F22national] reference centres for the authenticity and integrity of the agri-food chain provided for in Article 97.

[F232.Subject to paragraph 2A, the appropriate authority may make regulations supplementing this Regulation concerning the establishment of requirements, responsibilities and tasks for the national reference centre for animal welfare and the national reference centre for the authenticity and integrity of the agri-food chain, in addition to those laid down in Articles 95 to 98.

2A.The appropriate authority may only exercise the power to make regulations under paragraph 1 where the appropriate authority considers that new or emerging risks, new or emerging animal diseases or pests of plants, or new legal requirements make the exercise of this power appropriate.]

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Article 100U.K.Designation of national reference laboratories

[F261.The appropriate authority must designate one or more laboratories to act as national reference laboratories for Great Britain, in such of those areas governed by the rules referred to in Article 1(2) as the appropriate authority considers appropriate.]

1A.[F27The national reference laboratories designated in accordance with paragraph 1 may—

be situated in the United Kingdom, or in another country;

be designated in relation to more than one area of the rules referred to in Article 1(2);

apply in relation to areas of those rules falling within the responsibilities of more than one competent authority.

1B.Where the appropriate authority considers it appropriate, the power to designate a laboratory as a national reference laboratory in accordance with paragraph 1 may be exercised by a competent authority.]

2.The requirements provided for in point (e) of Article 37(4), Article 37(5), Article 39 and Article 42(1), points (a) and (b) of Article 42(2) and Article 42(3) shall apply to national reference laboratories.

By way of derogation from point (e) of Article 37(4), for the area governed by the rules referred to in point (g) of Article 1(2), [F28the appropriate authority or, in a case where the power to designate has been delegated to a competent authority in accordance with paragraph 1B, a competent authority, may designate as a national reference laboratory an official laboratory designated as such in accordance with regulations made under Article 41, irrespective of whether it fulfils] the condition provided for in point (e) of Article 37(4).

3.National reference laboratories shall:

(a)be impartial, free from any conflict of interests, and in particular not be in a situation which may, directly or indirectly, affect the impartiality of their professional conduct as regards the exercise of their tasks as national reference laboratories;

(b)have, or have contractual access to, suitably qualified staff with adequate training in analytical, testing and diagnostic techniques in their area of competence, and support staff as appropriate;

(c)possess, or have access to, the infrastructure, equipment and products needed to carry out the tasks assigned to them;

(d)ensure that their staff and any contractually engaged staff have good knowledge of international standards and practices and that the latest developments in research at nationalF29... and international level are taken into account in their work;

(e)be equipped with, or have access to, the necessary equipment to perform their tasks in emergency situations; and

(f)where relevant, be equipped to comply with relevant biosecurity standards.

[F304.The appropriate authority, or, in a case where the power to designate has been delegated to the competent authority, the competent authority, must—

(a)publish online the name and address of each national reference laboratory designated in accordance with paragraph 1; and

(b)ensure that the information published in accordance with point (a) is kept up to date.]

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Textual Amendments

Article 101U.K.Responsibilities and tasks of national reference laboratories

1.National reference laboratories shall, in their area of competence:

[F33(a)where appropriate—

(i)collaborate with other national and international laboratories;

(ii)participate in inter-laboratory comparative tests organised by the laboratories referred to in point (i), or by proficiency test providers accredited to ISO/IEC 17043;]

(b)coordinate the activities of official laboratories designated in accordance with Article 37(1) with a view of harmonising and improving the methods of laboratory analysis, test or diagnosis and their use;

(c)where appropriate, organise inter-laboratory comparative testing or proficiency tests between official laboratories, ensure an appropriate follow-up of such tests and inform the competent authorities of the results of such tests and follow-up;

[F34(d)provide scientific and technical assistance to the competent authorities and official laboratories;]

(e)provide within the scope of their mission scientific and technical assistance to the competent authorities for the implementation of MANCPs referred to in Article 109 and of coordinated control programmes adopted in accordance with Article 112;

(f)where relevant, validate the reagents and lots of reagents, establish and maintain up-to-date lists of available reference substances and reagents and of manufacturers and suppliers of such substances and reagents;

(g)where necessary, conduct training courses for the staff of official laboratories designated under Article 37(1); and

(h)assist actively the [F35competent authorities] in the diagnosis of outbreaks of foodborne, zoonotic or animal diseases or of pests of plants and in case of non-compliance of consignments, by carrying out confirmatory diagnoses, characterisation and epizootic or taxonomic studies on pathogen isolates or pest specimens.

[F362.The appropriate authority may make regulations prescribing additional tasks and responsibilities for national reference laboratories, provided that these tasks and responsibilities are limited to those made necessary by new or emerging risks, new or emerging animal diseases or pests of plants or new legal requirements.]

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