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Commission Regulation (EU) No 142/2011 of 25 February 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)
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Version Superseded: 16/07/2019
Point in time view as at 02/08/2017.
There are currently no known outstanding effects for the Commission Regulation (EU) No 142/2011, ANNEX XVI.
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It shall, in particular:
check:
the general conditions of hygiene of the premises, equipment and staff;
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;
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;
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 Union legislation or, where no such methods are laid down in Union legislation, in accordance with recognised international standards or, in their absence, national standards; and
the storage conditions;
take any samples required for laboratory tests; and
make any other checks it considers necessary to ensure compliance with Regulation (EC) No 1069/2009 and with this Regulation.
a description of the process by a process flow diagram;
an identification of critical control points (CCPs) including the material process rate for continuous systems;
the compliance with the specific process requirements laid down by this Regulation; and
the achievement of the following requirements:
particle size for batch-pressure and continuous processes, defined by the mincer hole or the anvil gap size;
temperature, pressure, processing time and, in the case of continuous processing systems, the material processing rate, as specified in points 2 and 3.
the temperature must be monitored with a permanent thermocouple and it must be plotted against real time;
the pressure stage must be monitored with a permanent pressure gauge; pressure must be plotted against real time;
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.
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;
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:
feed screw revolutions per minute (rev./min.);
the electric power (amps at given voltage);
the evaporation/condensation rate; or
the number of pump strokes per unit time.
All measuring and monitoring equipment must be calibrated at least once a year.
In order to assist Member States in making up-to-date lists of registered and approved establishments, plants and operators available to other Member States and to the public, the Commission shall provide a website which shall contain links to the national websites provided by each Member State, as referred to in point 2(a).
Each Member State shall provide the Commission with a linking address to a single national website containing the master list of all registered and approved establishments, plants and operators on its territory (‘master list’).
Each master list shall consist of one sheet and shall be completed in one or more official languages of the Union.
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.
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.
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.
the appropriate composition, processing and use of the feed containing meat-and-bone meal or other products which have been processed in accordance with the processing methods set out in Chapter III of Annex IV and which are derived from the bodies or parts of bodies of animals of the same species;
that the animals are fed with the feed referred to in point (a), including:
strict supervision of the health status of those animals; and
appropriate TSE surveillance involving regular sampling and laboratory examination for TSEs.
include collection centres into the list drawn up in accordance with Article 47(1) of Regulation (EC) No 1069/2009;
assign an official number to each collection centre; and
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.
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
F1 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).
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.
The competent authority shall carry out documentary checks in approved photographic factories referred to in Table 3 of point 1 of Section 11 of Chapter II of Annex XIV on the channelling chain from the border inspection posts of first entry to the approved photographic factories for the purpose of reconciliation of the quantities of products imported, used and disposed of.
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 border inspection posts of first entry to the registered establishment or plant for the purpose of reconciliation of the quantities of products imported, used and disposed of.
Operators shall apply to the competent authority of the Member State of destination for the authorisation of the dispatch of animal by-products and derived products referred to in Article 48(1) of Regulation (EC) No 1069/2009 in accordance with the following format:]
Textual Amendments
F2 Substituted by Commission Implementing Regulation (EU) No 1097/2012 of 23 November 2012 amending 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 as regards dispatch of animal by-products and derived products between Member States (Text with EEA relevance).
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:
of the amount of materials which are hydrolysed at the site;
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
F3 Substituted by Commission Regulation (EU) 2015/9 of 6 January 2015 amending 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).
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.]
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