Commission Regulation (EU) No 142/2011Dangos y teitl llawn

ANNEX XVI U.K. OFFICIAL CONTROLS

CHAPTER I U.K. OFFICIAL CONTROLS IN PROCESSING PLANTS

Section 1 U.K. Supervision of the production

1. The competent authority shall supervise processing plants to ensure compliance with the requirements of Regulation (EC) No 1069/2009 and with this Regulation. U.K.

It shall, in particular:

(a)

check:

(i)

the general conditions of hygiene of the premises, equipment and staff;

(ii)

the efficacy of the own checks carried out by the operator of the processing plant, in accordance with Article 28 of Regulation (EC) No 1069/2009; such checks must include an examination of the results of those checks and if necessary, the taking of samples;

(iii)

the effective implementation of the permanent written procedure based on the HACCP principles in accordance with Article 29(1) of Regulation (EC) No 1069/2009; such checks must include an examination of the results of this implementation and if necessary, the taking of samples;

(iv)

the standards of the products after processing; the analyses and tests must be carried out in accordance with scientifically recognised methods, in particular, those laid down in [F1 retained EU law] or, where no such methods are laid down in [F1 retained EU law], in accordance with recognised international standards or, in their absence, national standards; and

(v)

the storage conditions;

(b)

take any samples required for laboratory tests; and

(c)

make any other checks it considers necessary to ensure compliance with Regulation (EC) No 1069/2009 and with this Regulation.

Textual Amendments

F1 Words in Regulation substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(2)(a)

2. To allow it to carry out its responsibilities under point 1, the competent authority must have free access at all times to all parts of the processing plant and to records, commercial documents and health certificates. U.K.

Section 2 U.K. Validation procedures

1. Prior to issuing an approval for a processing plant, as provided for in Article 44(1) of Regulation (EC) No 1069/2009, the competent authority must check that a validation of the processing plant has been carried out by the operator in accordance with the following procedures and indicators: U.K.

(a)

a description of the process by a process flow diagram;

(b)

an identification of critical control points (CCPs) including the material process rate for continuous systems;

(c)

the compliance with the specific process requirements laid down by this Regulation; and

(d)

the achievement of the following requirements:

(i)

particle size for batch-pressure and continuous processes, defined by the mincer hole or the anvil gap size;

(ii)

temperature, pressure, processing time and, in the case of continuous processing systems, the material processing rate, as specified in points 2 and 3.

2. In the case of a batch pressure system: U.K.

(a)

the temperature must be monitored with a permanent thermocouple and it must be plotted against real time;

(b)

the pressure stage must be monitored with a permanent pressure gauge; pressure must be plotted against real time;

(c)

the processing time must be shown by time/temperature and time/pressure diagrams.

At least once a year the thermocouple and the pressure gauge must be calibrated.

3. In the case of a continuous pressure system: U.K.

(a)

the temperature and the pressure must be monitored with thermocouples, or an infrared temperature gun, and pressure gauges must be used at defined positions throughout the process system in such a way that temperature and pressure comply with the required conditions inside the whole continuous system or in a section of it; the temperature and pressure must be plotted against real time;

(b)

measurement of the minimum transit time inside the whole relevant part of the continuous system where the temperature and pressure comply with the required conditions, must be provided to the competent authorities, using insoluble markers, such as manganese dioxide, or a method which offers equivalent guarantees.

Accurate measurement and control of the material process rate is essential and must be measured during the validation test in relation to a CCP that can be continuously monitored such as:

(i)

feed screw revolutions per minute (rev./min.);

(ii)

the electric power (amps at given voltage);

(iii)

the evaporation/condensation rate; or

(iv)

the number of pump strokes per unit time.

All measuring and monitoring equipment must be calibrated at least once a year.

4. The competent authority must repeat the checks on the validation procedures when it considers it necessary, and in any case each time any significant alterations are made to the process, such as modifications of the machinery or changes of raw materials. U.K.

CHAPTER II U.K. LISTS OF REGISTERED AND APPROVED ESTABLISHMENTS, PLANTS AND OPERATORS

1. Access to lists of registered and approved establishments, plants and operators U.K.

In order to assist [F2 each other] in making up-to-date lists of registered and approved establishments, plants and operators available to F3 ... the public, [F4 each appropriate authority] shall provide a website which shall contain links to the national websites provided by each [F5 other], as referred to in point 2(a).

Textual Amendments

F2 Words in Annex 16 Ch. 2 point 1 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(a)(i)

F3 Words in Annex 16 Ch. 2 point 1 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(a)(ii)

F4 Words in Annex 16 Ch. 2 point 1 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(a)(iii)

F5 Word in Annex 16 Ch. 2 point 1 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(a)(iv)

2. Format for national websites U.K.

(a)

Each [F6 appropriate authority] shall provide [F7 each other] with a linking address to a singleF8 ... website containing the master list of all registered and approved establishments, plants and operators [F9 in their respective constituent nation] (‘master list’).

(b)

Each master list shall consist of one sheet and shall be completed in [F10 at least English].

Textual Amendments

F6 Words in Annex 16 Ch. 2 point 2(a) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(b)(i)(aa)

F7 Words in Annex 16 Ch. 2 point 2(a) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(b)(i)(bb)

F8 Word in Annex 16 Ch. 2 point 2(a) omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(b)(i)(cc)

F9 Words in Annex 16 Ch. 2 point 2(a) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(b)(i)(dd)

F10 Words in Annex 16 Ch. 2 point 2(b) substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(b)(ii)

3. The layout, including the relevant information and codes, of master lists shall follow the technical specifications which are published by the [F11 appropriate authority] on its website. U.K.

Textual Amendments

F11 Words in Annex 16 Ch. 2 point 3 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(107)(c)

CHAPTER III U.K. SPECIFIC REQUIREMENTS FOR OFFICIAL CONTROLS

Section 1 U.K. Official controls regarding marking of derived products

The competent authority shall carry out a performance check of the monitoring and recording system referred to in point 2 of Chapter V of Annex VIII to this Regulation to ascertain compliance with this Regulation and may, where necessary, request the testing of additional samples in accordance with the method referred to in the second paragraph of the same point.

Section 2 U.K. Official controls in low-capacity incineration plants

The competent authority shall inspect a low-capacity incineration plant for incineration of specified risk materials before approval, and at least once a year to monitor compliance with Regulation (EC) No 1069/2009 and with this Regulation.

Section 3 U.K. Official controls in remote areas

In the case of disposal of animal by-products in remote areas in accordance with Article 19(1)(b) of Regulation (EC) No 1069/2009, the competent authority shall monitor regularly the areas categorised as remote areas to ensure that those areas and the disposal operations are properly controlled.

F12 Section 4 U.K. Official controls in registered farms for the feeding of fur animals

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F12 Annex 16 Ch. 3 Section 4 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(108)(a)

Section 5 U.K. Official controls regarding collection centres

1. The competent authority shall: U.K.

(a)

include collection centres into the list drawn up in accordance with Article 47(1) of Regulation (EC) No 1069/2009;

(b)

assign an official number to each collection centre; and

(c)

update the list of collection centres and make it available together with the list drawn up in accordance with Article 47(1) of Regulation (EC) No 1069/2009.

2. The competent authority shall carry out official controls at collection centres in order to verify compliance with this Regulation. U.K.

[F13 Section 6 U.K. Official controls regarding the feeding of wild animals and certain zoo animals with Category 1 material

The competent authority shall monitor the health status of the farmed animals in the region where feeding is carried out as referred to in Sections 2, 3 and 4 of Chapter II of Annex VI and shall carry out appropriate TSE surveillance involving regular sampling and laboratory examination for TSEs.

Those samples shall include samples taken from suspected animals and from older breeding animals.]

Textual Amendments

F13 Substituted by Commission Regulation (EU) No 294/2013 of 14 March 2013 amending and correcting Regulation (EU) No 142/2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (Text with EEA relevance).

Section 7 U.K. Official controls regarding the application of certain organic fertilisers and soil improvers

The competent authority shall carry out controls along the entire chain of production and use of organic fertilisers and soil improvers subject to the restrictions referred to in Chapter II of Annex II.

Those controls shall include checks on the mixing with a component referred to in point 2 of Section 1 of Chapter II of Annex XI, and checks on the stocks of such products kept on farm and the records kept in accordance with Regulation (EC) No 1069/2009 and with this Regulation.

Section 8 U.K. Official controls regarding approved photographic factories

The competent authority shall carry out documentary checks in [F14 the approved photographic factory at Kodak Ltd., Headstone Drive, Harrow, Middlesex HA4 4TY] on the channelling chain from the [F15 border control post]s of first entry to the approved photographic [F16 factory] for the purpose of reconciliation of the quantities of products imported, used and disposed of.

Textual Amendments

F14 Words in Annex 16 Ch. 3 Section 8 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(108)(b)(i)

F15 Words in Regulation substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(2)(b)

F16 Word in Annex 16 Ch. 3 Section 8 substituted (E.W.S.) (31.12.2020) by The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(108)(b)(ii)

Section 9 U.K. Official controls regarding certain imported rendered fats

The competent authority shall carry out documentary checks in registered establishments or plants receiving rendered fats which have been imported in accordance with Section 9 of Chapter II of Annex XIV on the channelling chain from the [F15 border control post]s of first entry to the registered establishment or plant for the purpose of reconciliation of the quantities of products imported, used and disposed of.

F17 Section 10 U.K. Standard format for applications for certain authorisations in intra-Union trade

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F17 Annex 16 Ch. 3 Section 10 omitted (E.W.S.) (31.12.2020) by virtue of The Animals, Aquatic Animal Health, Invasive Alien Species, Plant Propagating Material and Seeds (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1388), regs. 1(2)(c), 13(108)(c)

[F18 Section 11 U.K. Official controls regarding hydrolysis with subsequent disposal

The competent authority shall carry out controls at sites where hydrolysis with subsequent disposal is carried out in accordance with point B of Section 2 of Chapter V of Annex IX.

Such controls shall, for the purpose of reconciliation of the quantities of hydrolysed materials dispatched and disposed of, include documentary checks:

(a)

of the amount of materials which are hydrolysed at the site;

(b)

in the establishments or plants where the hydrolysed materials are disposed of.

Controls shall be carried out regularly on the basis of a risk assessment.

During the period of the first 12 months of operation, a control visit to a site, where a container for the hydrolysis is located, shall be carried out every time hydrolysed material is collected from the container.

Following the period of the first 12 months of operation, a control visit to such sites shall be carried out every time the container is emptied and checked for the absence of corrosion and leaking in accordance with point B(3)(j) of Section 2 of Chapter V of Annex IX.]

Textual Amendments

F18 Inserted by Commission Regulation (EU) 2020/762 of 9 June 2020 amending Regulation (EU) No 142/2011 as regards microbiological standards for raw petfood, requirements concerning approved establishments, technical parameters applicable to the alternative method Brookes’ gasification process and hydrolysis of rendered fats, and exports of processed manure, certain blood, blood products and intermediate products (Text with EEA relevance).

[F19 Section 12 U.K. Official controls regarding plants approved for the combustion of animal by-products

The competent authority shall carry out documentary checks in accordance with the procedures referred to in Article 6(7) and (8) in approved plants referred to in Chapter V of Annex III.]

Textual Amendments

F19 Substituted by Commission Regulation (EU) 2020/735 of 2 June 2020 amending Regulation (EU) No 142/2011 as regards the use of meat-and-bone meal as a fuel in combustion plants (Text with EEA relevance).