S.I. No. 182/2000 - European Communities (Processing of Mammalian Animal By-Products) Regulations, 2000

I, Joe Walsh, Minister for Agriculture, Food and Rural Development, in exercise of the powers conferred on me by section 3 of the European Communities Act, 1972 (No. 27 of 1972), and for the purpose of giving effect to Council Decision No. 1999/534/EC¹ of 19 July 1999, hereby make the following Regulations:-

1.       (1)     These Regulations may be cited as the European Communities (Processing of Mammalian Animal By-Products) Regulations, 2000.

(2)     These Regulations shall come into operation on the 30th day of June, 2000.

2.       (1)      In these Regulations -

“authorised officer” means a person who, for the time being, stands appointed under Regulation 9 of these Regulations or an inspector;

“the Council Decision” means Council Decision No. 1999/534/EC of 19 July 1999;

“the Council Directive” means Council Directive No. 90/667/EEC² of 27 November 1990 as last amended by Council Directive No. 92/118/EEC³ of 17 December 1992;

“export” means export from the State;

“import” means import into the State;

“inspector” means an inspector within the meaning of the Diseases of Animals Act, 1966 (No. 6 of 1966);

“the Minister” means the Minister for Agriculture, Food and Rural Development;

“sell” includes supply with or without remuneration.

(2)     In these Regulations -

(a)     a reference to a Regulation is to a Regulation of these Regulations, unless it appears that reference to some other provision is intended;

(b)     a reference to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it appears that reference to some other provision is intended;

(c)     a reference to a Schedule is to a Schedule to these Regulations.

(3)     A word or expression that is used in these Regulations and is also used in the Council Decision has, unless the contrary intention appears, the meaning in these Regulations that it has in the Council Decision.

3.       (1)     A person shall not process high-risk or low-risk mammalian animal by-products, including mammalian by-products not intended for human consumption derived from the production of products intended for human consumption, unless they are processed in accordance with the requirements laid down in the First Schedule.

(2)     A person shall not sell or supply for sale any mammalian animal by-products, including mammalian by-products not intended for human consumption derived from the production of products intended for human consumption, unless they have been processed in accordance with the requirements laid down in the First Schedule.

(3)     A person shall not use mammalian animal by-products for feeding to animals or poultry, including mammalian by-products not intended for human consumption derived from the production of products intended for human consumption, unless they have been processed in accordance with the requirements laid down in the First Schedule.

(4)     A person shall not import or attempt to import mammalian animal by-products, including mammalian by-products not intended for human consumption derived from the production of products intended for human consumption, unless they have been processed in accordance with the requirements laid down in the First Schedule.

(5)     A person shall not export or attempt to export mammalian animal by-products, including mammalian by-products not intended for human consumption derived from the production of products intended for human consumption, unless they have been processed in accordance with the requirements laid down in the First Schedule.

4.       The provisions of Regulation 3 shall not apply to:

(a)  (i)          the processing of low risk material within the meaning of the Council Directive for the production of pet food,

(ii)          feed for animals referred to in Article 7 (ii) of the Council Directive for the feeding of zoo, circus or fur animals, recognised packs of hounds and maggot farming for fishing bait,

(iii)         degreased bones for the production of gelatine,

(iv)         hides and skins for the production of gelatine, collagen and hydrolysed proteins, hooves, horns, hair,

(v)          glands, tissues and organs for pharmaceutical use,

(vi)         blood and blood products,

(vii)        milk and milk products,

(viii)       non-ruminant by-products for the production of rendered fats, excluding greaves derived from such production,

(ix)         low-risk ruminant by-products for the production of rendered fats excluding greaves derived from such production,

(x)         animal by-products for the production of products in relation to which it can be assured by the owner or person in charge of such products, to the satisfaction of the Minister, that they will not enter any human food or animal feed chain and will not be used as fertilisers;

(b)     and, until 1 July 2000:

(i)       high-risk ruminant by-products for the production of rendered fats, excluding greaves derived from such production,

(ii)      bones fit for human consumption.

5.       (1)     With effect from 1 January 2001, a person shall not produce rendered fats derived from ruminant animal by-products unless such fats are purified in such a way that the maximum levels of remaining total insoluble impurities do not exceed 0.15% by weight.

(2)     The provisions of Regulation 3 and paragraph (1) of this Regulation shall not apply to the production of rendered fats derived from ruminant by-products if they are to be processed, to the satisfaction of the Minister, by a method which at least meets the standards of one of the processes set down in the Second Schedule or it can be assured, to the satisfaction of the Minister, by the owner or person in charge of the plant producing the rendered fats that such fats will not enter any human food or animal feed chain.

6.       Notwithstanding the provisions of Regulations 3 and 5, the Minister may authorise -

(a)     the processing of mammalian animal by-products by a method which does not achieve the requirements set out in the First Schedule if he is satisfied that such processing is followed by a process which achieves the requirements set out in the First Schedule;

(b)     the supply of mammalian animal by-products or any resulting proteinaceous material for burial, incineration, burning as a fuel or a similar method which ensures safe disposal.

7.       (1)     The Minister may, for the purposes of Regulation 3, authorise a plant for the processing of mammalian animal by-products where he is satisfied that such plant operates in accordance with the requirements laid down in the First Schedule and follows the validation procedures laid down in the Third Schedule.

(2)     The Minister may attach such conditions, as he sees fit, to an authorisation granted under this Regulation, or subsequently, and, may amend or revoke any such conditions and shall notify the owner or person in charge of the plant in writing of the conditions, amendment or revocation concerned.

(3)     The Minister may, if he is satisfied that the relevant provisions of these Regulations are not being complied with in relation to a plant, -

(a)     refuse to authorise the plant, or

(b)     suspend or revoke an authorisation,

and shall notify the owner or person in charge of the plant in writing of the refusal, revocation or suspension and the reasons therefor. In the event of continued non compliance with these Regulations or failure by the owner or person in charge of the authorised plant to take the measures required under these Regulations the Minister may either temporarily suspend or revoke the authorisation.

(4)     The Minister shall not -

(a)     revoke or suspend the authorisation given under this Regulation, or

(b)     refuse to authorise a plant on foot of an application, without -

(i)     notifying the holder of, or applicant for, the authorisation of his intention to revoke, suspend or refuse the authorisation, as the case may be;

(ii)     specifying the reason for the intended revocation, suspension or refusal, as the case may be; and

(iii)     affording the holder of, or the applicant for, the authorisation an opportunity of making representations or having representations made on his behalf within 14 days, to the Minister in relation to the proposed revocation, suspension or refusal, as the case may be.

(5)     The Minister may restore the authorisation, if such authorisation has been suspended in accordance with paragraph (3), where -

(a)     the owner or person in charge of the suspended plant has rectified the shortcomings notified to him by the Minister,

(b)     the Minister is satisfied that the suspended plant has been operating in accordance with the requirements set out in the First Schedule and following the validation procedures laid down in the Third Schedule, and

(c)     the Minister is satisfied that the suspended plant will fully comply with the requirements of these Regulations.

(6)     Notwithstanding the other provisions of this Regulation, the Minister may, where he is satisfied that there is a serious and immediate risk to animal and human health, suspend without notice an authorisation granted under paragraph (1).

8.       A person who is for the time being the owner or person in charge of a plant authorised by the Minister in accordance with Regulation 7 shall ensure that records of the residence time, temperature, pressure and particle size of mammalian animal by-products processed at that plant are maintained for examination, upon request, by an authorised officer for a period of at least five years.

9.       (1)     The Minister may appoint such and so many persons as he thinks fit to be authorised officers for the purposes of these Regulations.

(2)     An authorised officer, when exercising any power conferred on him by these Regulations, shall, if so requested by any person affected, produce evidence in writing of his appointment as an authorised officer or inspector.

10.     (1)     An authorised officer may, for the purposes of these Regulations or the Council Decision -

(a)     at all reasonable times, enter any premises or place, and any vehicle, wagon, vessel or other means of transport (other than any premises, place or means of transport consisting of a dwelling or other than so much thereof as consists of a dwelling) where he reasonably suspects that any product or document which he considers should be examined or inspected for the purposes of his functions under these Regulations is to be found,

(b)     there or at any other place, examine and inspect any product or document,

(c)     take, without payment of compensation, such samples of any product at the premises or place or on or in the means of transport as he may reasonably require for the purposes of his functions under these Regulations and carry out or have carried out on the samples such analyses, examinations, checks and inspections as he considers necessary or expedient for the purposes of such functions,

(d)     there or at any other place, carry out or have carried out such examinations, checks and inspections of the premises, place or means of transport and any equipment, machinery or plant and any product found there as he reasonably considers necessary or expedient for the purposes of such functions,

(e)      require any person at the premises or place or on or in the means of transport and the owner or person in charge thereof and any person employed in connection therewith to give to him such information and to produce to him such books, certificates, documents and other records, including any records required to be kept by these Regulations, within the power or procurement of the person as he may reasonably require for the purposes of his functions under these Regulations,

(f)     examine and take copies of, or of extracts from, any such records as aforesaid,

(g)     seize and detain anything found there which he reasonably believes to be evidence of an offence under these Regulations.

(2)     A person shall not, in purported compliance with a requirement under paragraph (1)(e) above, give information to an authorised officer that he knows to be false or misleading in a material respect.

11.     (1)     A person who contravenes a provision of these Regulations shall be guilty of an offence and shall be liable on summary conviction to a fine not exceeding £1,500 or to imprisonment for a term not exceeding six months or to both.

(2)     A person shall not obstruct or impede an authorised officer in the due exercise of any of the functions of the officer under these Regulations.

(3)     Where an offence under these Regulations is committed by a body corporate and is proven to have been so committed with the consent or connivance of or to be attributable to any neglect on the part of any person, being a director, manager, secretary or other officer of the body corporate, or a person who was purporting to act in any such capacity, that person, as well as the body corporate, shall be guilty of an offence and shall be liable to be proceeded against and punished as if he were guilty of the first-mentioned offence.

12.     An offence under these Regulations may be prosecuted by the Minister.

13.     These Regulations are in addition to and not in substitution for -

(a)      the European Communities (Disposal, Processing and Placing on the Market of Animal By-products) Regulations, 1994 ( S.I. No. 257 of 1994 ),

(b)      the European Communities (Importation of Bovine Animals and Products obtained from Bovine Animals from the United Kingdom) Regulations, 1999 ( S.I. No. 464 of 1999 ),

(c)      the Diseases of Animals (Bovine Spongiform Encephalopathy) (Specified Risk Material) Order, 1997 ( S.I. No. 80 of 1997 ),

(d)      the European Communities (Mammalian Animal Waste) Regulations, 1998 ( S.I. No. 2 of 1998 ).

14.     The European Communities (Processing of Mammalian Animal Waste) Regulations, 1998 ( S.I. No. 62 of 1998 ) are hereby revoked.

First Schedule (Regulation 3)

Minimum requirements for the processing of mammalian animal by-products:

Processing may be carried out in a batch or continuous system.

Second Schedule (Regulation 5)

Processes for rendered fats derived from ruminant by-products:

1. Transesterification or hydrolysis at least 200°, under corresponding appropriate pressure for 20 minutes (glycerol, fatty acids and esters);

2. Saponification with NaOH 12M (glycerol and soap):

-         in a batch process at 95°C for three hours,

or

-         in a continuous process at 140°C, 2 bars (2000 hPa) for eight minutes or such equivalent conditions as the Minister may determine.

Third Schedule (Regulation 7)

Validation procedures for Plants Processing Mammalian Animal By-products

Validation Procedures shall take into account the following indicators:

1.      Description of the process (by a process flow diagram).

2.      Identification of Critical Control Points (CCPs) including the material process rate for continuous systems.

3.      Compliance with the following process requirements:

4.      Achievement of the requirements laid down in the First Schedule:

(a)     Particle size for batch-pressure and continuous systems: the particle size is defined by the mincer hole or the anvil gap size.

(b)     Temperature, pressure, processing time and material processing rate (for continuous system only):

(i)      batch pressure system:

-         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.

(ii)      continuous pressure system:

-         The temperature and pressure must be monitored with thermocouples, or an infrared temperature gun, and pressure gauges used at defined positions throughout the process system in such a way that temperature and pressure comply with the conditions set out in the First Schedule 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 conditions set out in the First Schedule, must be provided to the Minister, using insoluble markers (e.g. 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), or

-         electric power (amps at given voltage), or

-         evaporation/condensation rate, or

-         number of pump strokes per unit time.

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

These validation procedures shall be repeated, when considered necessary by the Minister, and in any case each time any significant alterations are made to the process (e.g. modification of machinery, change of raw materials, etc.).

EXPLANATORY NOTE

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations implement Council Decision No. 1999/534/EC of 19 July 1999 concerning heat treatment for the processing of animal protein with a view to the inactivation of Transmissible Spongiform Encephalopathy agents.

¹ O.J. No. L 204 of 4.8.1999, p.37.

² O.J. No. L 363 of 27.12.1990, p.51.

³ O.J. No. L 62 of 15.3.1993, p.49.