SR 2005/104 动物产品(乳制品)条例2005(Animal Products (Dairy) Regulations 2005)

　　Animal Products （Dairy） Regulations 2005

　　（SR 2005/104）

　　1 Title

　　These regulations are the Animal Products （Dairy） Regulations 2005.

　　2 Commencement

　　These regulations come into force on 1 June 2005.

　　3 Interpretation

　　In these regulations, unless the context otherwise requires,—

　　Act means the Animal Products Act 1999

　　colostrum means milk given by a milking animal—

　　（a） within the first 4 days after giving birth; or

　　（b） if there are fewer than 8 full milkings of the animal within that 4-day period, within the first 8 full milkings after giving birth or within such other number of milkings as the Director-General may specify essential services includes, without limitation, process gases, lighting, refrigeration, ventilation, vacuum, water, and waste management

　　ingredient means anything added to dairy material that may or may not form part of the final product, and includes processing aids

　　maintenance compound means, in relation to any premises or place where dairy material or dairy product is processed, any substance—

　　（a） used for maintaining, repairing, servicing, cleaning, or sanitising equipment or surfaces or air that may be the source of, or result in, contamination of dairy material, dairy product, or associated things; or

　　（b） used for treating water; or

　　（c） used for pest control

　　specialty milk means milk of unusual composition, whether natural or otherwise, that is intended for a special purpose

　　waste includes, without limitation, all solids, liquids, and gases that the operator intends to dispose of as being unwanted.

　　4 Dairy material to be suitable for processing into dairy product

　　（1） Dairy material used for processing into dairy product, and any ingredients added to that material, must be suitable for that purpose.

　　（2） Where required by specifications, the supplier of dairy material for processing into dairy product, or other specified person, must, in accordance with the specifications, provide the following types of information relating to the status of the dairy material when it is presented for processing:

　　（a） the name, physical location, contact details, or unique identifier of the processing premises:

　　（b） matters relating to the fitness of the material for its intended purpose:

　　（c） its nature and physical condition:

　　（d） its origin:

　　（e） its composition:

　　（f） its ingredients:

　　（g） the type of treatment applied to the material:

　　（h） its net contents:

　　（i） its lot identifier.

　　（3） The information provided must be accurate.

　　5 Non-conforming dairy material or dairy product

　　（1） A risk management programme operator or any person specified in specifications for the purposes of this subclause must follow any prescribed procedures specified by the Director-General or obtain the consent in writing from the Director-General before disposing of any dairy material or dairy product that is non-conforming.

　　（2） For the purposes of subclause （1）， specifications may specify criteria for what is considered to be non-conforming dairy material or dairy products, and specify management requirements for non-conforming material or product.

　　6 Dairy product to be wholesome and free of hazards

　　（1） Taking into consideration its intended use, dairy product must be wholesome and must not contain biological, chemical, or physical hazards at a level that may be directly or indirectly harmful to humans or animals.

　　（2） For the purposes of subclause （1）， specifications may specify—

　　（a） risk factors for dairy material and dairy product and the way in which these risks must be controlled, including the processing steps that must be applied:

　　（b） acceptable or unacceptable levels of hazards, objects, materials, and substances in relation to any type or class of dairy material and dairy product.

　　7 Composition of dairy material or product

　　（1） All risk management programme operators, and all other categories of processor of dairy material or dairy product specified in specifications for the purposes of this subclause, must ensure that the composition of dairy material and dairy product complies with any relevant composition requirements set out in the specifications.

　　（2） Specifications may also require the manufacturing method to be specified for a particular product or class of product.

　　8 Dairy material and product to be processed in manner that minimises contamination and deterioration

　　（1） All specified persons must ensure that dairy material and dairy product in their charge is handled or processed in a manner that minimises the contamination or deterioration of the dairy material or dairy product.

　　（2） Specifications may identify how dairy material and dairy product must be processed or handled in order to minimise contamination or deterioration.

　　9 Requirements for premises, places, facilities, equipment, and essential services

　　（1） All specified persons must ensure that the premises, places, facilities, equipment, and essential services for which they are responsible in relation to the processing of dairy material or dairy product are—

　　（a） located, designed, and constructed to enable suitability of the dairy material to be maintained, and the fitness of the dairy product for its intended purpose to be achieved and maintained:

　　（b） operated to minimise and manage the exposure of dairy material or dairy product or associated things to risk factors.

　　（2） Specifications may, for the purposes of subclause （1）， specify requirements for premises, places, facilities, equipment, and essential services.

　　10 Hygiene of processing environment

　　（1） All dairy processors and other persons specified in specifications for the purposes of this subclause must follow good hygiene practice within the processing environment.

　　（2） All specified persons must establish and carry out effective procedures to—

　　（a） ensure appropriate and adequate maintenance, cleaning, and sanitation of processing premises, places, facilities, essential services, and equipment （including conveyances）； and

　　（b） manage waste; and

　　（c） control pests; and

　　（d） control pathogenic micro-organisms; and

　　（e） ensure compliance with any other specified requirements.

　　（3） For the purposes of subclause （2）， a procedure is effective if it reduces to an acceptable level the exposure of dairy material and dairy product and associated things to risk factors associated with waste, pathogenic micro-organisms, pests, and inappropriate or inadequate maintenance, cleaning, and sanitation.

　　（4） All risk management programme operators and other persons specified in specifications for the purposes of this subclause must, in relation to premises or places used for processing, ensure that maintenance compounds are stored, handled, and used in a manner that reduces to an acceptable level contamination by the maintenance compounds of dairy material, dairy product, and associated things.

　　（5） The Director-General may—

　　（a） by specifications, provide that in certain areas, or for certain uses or equipment, only maintenance compounds that are listed in the specifications or approved by the Director-General may be used:

　　（b） impose conditions on the use of those maintenance compounds, whether in the specifications or in the approval.

　　（6） In deciding whether to impose requirements under subclause （5）， the Director-General must assess the risk of contamination of dairy material or product, and the ability to control the risk through conditions.

　　11 Hygiene of persons whose presence or actions may result in contamination of dairy material or dairy product

　　All risk management programme operators and other categories of person specified in specifications for the purposes of this regulation must ensure that persons, including visitors, whose presence or actions, at any premises or place where dairy material or product is processed, may result in contamination of dairy material or dairy product—

　　（a） wear appropriate protective clothing; and

　　（b） follow an appropriate personal hygiene routine; and

　　（c） behave in such a manner as may be necessary or desirable to minimise contamination to dairy material, dairy product, and associated things.

　　12 Persons infected by, or carriers of, disease or illness to be excluded from working areas or from handling dairy material or product

　　All risk management programme operators and other categories of person specified in specifications for the purposes of this regulation must ensure that persons, including visitors, who are known to be, or suspected of being, infected by or a carrier of a disease or illness of public

　　health concern （including a notifiable infectious disease listed in section A of Part 1 of Schedule 1 of the Health Act 1956） that is likely to be transmitted through dairy material, dairy product, or associated things are precluded from—

　　（a） working in areas where dairy material or dairy product is processed, if that may result in contamination of dairy product; or

　　（b） handling dairy material, dairy product, or associated things that may result in contamination of dairy product.

　　13 Required measuring equipment to be calibrated and function as intended

　　（1） All specified persons must ensure that measuring equipment that is used to carry out a critical measurement is properly calibrated and functions as intended.

　　（2） Specifications may—

　　（a） specify technical details for measurement and calibration and for maintenance of equipment:

　　（b） identify a parameter as critical when specifying critical measurements under subclause （1）。

　　14 Dairy material and product to be examined, sampled, and tested

　　All risk management programme operators, and all other categories of person specified in regulations or specifications for the purposes of this regulation, must ensure that—

　　（a） dairy material, dairy product, and associated things are examined, sampled, and tested in accordance with any relevant specifications that are appropriate to the class or description of the dairy material or dairy product or process concerned, or the risk factor to be managed, or any combination of these; and

　　（b） any specified actions arising as a result of the examination, sampling, or testing are taken.

　　15 Packaging requirements for dairy material and product

　　（1） All risk management programme operators and other categories of person specified in specifications for the purposes of this regulation must ensure that any packaging materials （including reusable packaging and inner and outer packaging of any kind） used for dairy material, dairy product, and associated things are designed, made, stored, and used in a manner that—

　　（a） maintains the status of the dairy material as suitable for use in processing; and

　　（b） maintains the status of the dairy product as fit for its intended purpose; and

　　（c） minimizes contamination of the dairy material or dairy product.

　　（2） Specifications may specify the types of packaging that may be used for dairy material or dairy product, requirements for cleanliness of packaging, and those materials and packaging types that may not be used for specified purposes.

　　16 Carriage and delivery requirements for dairy material and product

　　All dairy processors and other categories of person specified in specifications for the purposes of this regulation engaged in the transportation and delivery of dairy material or dairy product must, as far as practicable, ensure that the means of carriage and delivery are designed, made, maintained, and operated in a manner that ensures that—

　　（a） the dairy material or dairy product retains its fitness for purpose; and

　　（b） risk factors associated with such transportation or delivery are managed; and

　　（c） contamination or deterioration of dairy material or dairy product is minimised.

　　17 Identification system requirements

　　（1） All operators of risk management programmes, all exporters, and all other categories of person required by specifications to do so, must have a tracking system that—

　　（a） allows for the identification of dairy material, dairy product, and ingredients added to dairy material or dairy product; and

　　（b） enables the movement of the dairy material, dairy product, or ingredients to be traced throughout the dairy processing, either forwards or backwards.

　　（2） The Director-General may, by specifications, require persons other than dairy processors and exporters to maintain a tracking system.

　　18 Labelling and identification requirements

　　（1） Dairy material and dairy product must be labelled or identified in accordance with any relevant specifications.

　　（2） Any labelling or identification required by specifications must—

　　（a） clearly relate to the dairy material or dairy product to which it applies; and

　　（b） contain information that accurately describes or differentiates the dairy material or dairy product to which it applies; and

　　（c） declare the manufacturing method used for the dairy product to which it applies.

　　（3） The Director-General may, by specifications, require dairy processors or other categories of person to label or identify dairy material or dairy product in accordance with the specifications.

　　19 Dairy material or dairy product not to be associated with false or misleading representation

　　（1） Dairy material, dairy product or any ingredient added to dairy material or product, must not be associated with a false or misleading representation of any kind concerning—

　　（a） the supplier's name or the unique identifier of the processing premises:

　　（b） the lot identifier of the product or product identification:

　　（c） the fitness of the material or product for its intended purpose:

　　（d） its nature and physical condition:

　　（e） its origin:

　　（f） its composition:

　　（g） its ingredients:

　　（h） the proportions of its ingredients or other constituents:

　　（i） the type of treatment applied to the material or product:

　　（j） its net contents.

　　（2） Specifications may specify requirements as to the labelling and presentation of dairy material and dairy products.

　　20 Record and return requirements

　　The Director-General may specify details of records and returns required to be kept or made by dairy processors or other persons in order to enable verification that any dairy material or dairy product is fit for its intended purpose.

　　21 Director-General to have regard to certain circumstances when making specifications

　　Before making specifications for the purposes of these regulations, the Director-General must be satisfied that at least 1 of the following  factors applies in relation to the proposed specifications:

　　（a） it is not reasonable or practicable for the relevant risks to be managed in some other way:

　　（b） the specifications are reasonable on the grounds of economic efficiency:

　　（c） the specifications are necessary to meet export requirements.

　　22 Duties of farm dairy owners

　　A farm dairy owner or any other person in charge of a farm dairy must ensure that—

　　（a） the farm dairy is located, designed, constructed, and operated in such a way as to enable raw milk to be produced so that it is fit for its intended purpose:

　　（b） the milking plant is designed so that materials and substances coming into contact with the milk do not contaminate it or cause it to deteriorate to an extent that it is no longer fit for its intended purpose:

　　（c） the use of agricultural compounds and similar substances in or near the farm dairy is controlled so that the milk remains fit for its intended purpose.

　　23 Requirements of farm dairy owners relating to essential services

　　（1） A farm dairy owner or any other person in charge of a farm dairy must ensure that—

　　（a） all essential services required for a farm dairy are available in sufficient quantities and are suitable for their purpose; and

　　（b） all water that may come into contact with raw milk during milking, including water used to clean the milking plant, is of suitable quality; and

　　（c） records are kept that demonstrate that the water that may come into contact with raw milk is suitable for the purpose.

　　（2） The records required to be kept under subclause （1）（c） must be available for inspection on request by the Director-General.

　　24 Duties of farm dairy operators or persons in charge of farm dairies

　　（1） A farm dairy operator or any other person in charge of a farm dairy is responsible for ensuring good hygienic practice in and surrounding the farm dairy and must—

　　（a） ensure that the farm dairy, milking plant, and equipment is used for appropriate purposes only:

　　（b） ensure appropriate and adequate maintenance, cleaning, sanitation, waste management, and pest control of the farm dairy:

　　（c） ensure that maintenance compounds are stored, handled, and used in a manner that minimises any possible contamination of dairy material or dairy product:

　　（d） ensure that only those maintenance compounds approved by the Director-General are used for the purpose of cleaning, sanitising,or maintaining the milking plant:

　　（e） ensure that any milk that is tainted or impure is withheld from processing:

　　（f） ensure that animals are milked only where they appear outwardly healthy and show no evidence of injury or clinical signs of diseases capable of contaminating the milk with pathogenic micro-organisms or toxic substances:

　　（g） ensure that any colostrum or other specialty milk being offered for sale for further processing is identified as such:

　　（h） manage the storage of dairy material to ensure that it remains fit for its intended purpose.

　　（2） Specifications may be made for the purposes of the matters set out in subclause （1）， and may specify operating procedures that must be followed in respect of those matters.

　　（3） A farm dairy operator or any other person in charge of a farm dairy is required to keep records to demonstrate compliance of the farm dairy with the above requirements. These records must be made available on request by the Director-General.

　　25 Milking animal health

　　（1） Farm dairy operators, herd owners, or any persons specified in specifications must—

　　（a） withhold milk that is not fit for its intended purpose, for example due to disease or exposure to risk factors:

　　（b） identify and, if necessary, isolate animals affected by injury, disease, or illness or animals undergoing treatment.

　　（2） Farm dairy operators, herd owners, and specified persons must keep records that demonstrate that they have complied with the requirements in subclause （1）。

　　（3） Specifications may be prepared to specify the manner in which milk must be withheld under subclause （1）（a）， and what may or must be done with any milk or dairy material that is withheld.

　　26 Recognised agencies and recognised persons

　　（1） If a particular function or activity is required under the Act to be carried out by a recognised agency or a recognised person,then the person with responsibility for ensuring that the function or activity is carried out must ensure that the function or activity is

　　carried out only by—

　　（a） an agency recognised under the Act to undertake responsibility for that function or activity; or

　　（b） a person recognised under the Act to undertake that function or activity.

　　（2） If a particular function or activity is required under the Act to be carried out by a recognised person under the management of a recognised agency, a recognised agency must offer and use for that function or activity only the services of a person properly recognised under the Act to carry out the function or activity.

　　（3） Specifications may specify the classes of agencies to be used for particular functions or activities.

　　27 Risk management programme evaluators and verifiers

　　（1） No person or agency may take responsibility for, or sign, a risk management programme evaluation report required by section 20

　　（2）（b） of the Act unless the person or agency is currently recognised under the Act to carry out risk management programme evaluation.

　　（2） No person or agency may carry out verification functions and activities unless that person or agency is currently recognised under the Act to carry out verification functions and activities.

　　（3） Specifications may specify requirements in relation to—

　　（a） the management of staff involved in evaluation and verification activities:

　　（b） the management of any non-compliance or conflict of interest in relation to evaluation or verification functions and activities:

　　（c） the reporting to the Director-General of matters relating to evaluation or verification functions and activities.

　　28 Verification of dairy processing operations or risk management operators

　　（1） The performance of dairy processing operations or risk management programmes must be verified at a frequency determined by the Director-General.

　　（2） Specifications may specify—

　　（a） the frequency and type of assessment in relation to the operation's history of compliance with their risk management programme:

　　（b） the manner in which any non-compliance with a risk management programme, or with any other requirement of or under the Act, is to be managed:

　　（c） matters requiring report to the Director-General.

　　29 Sale and supply of colostrum or other specialty milk

　　No person may sell or supply colostrum or other specialty milk for processing unless it is clearly identified as colostrum or specialty milk.

　　30 Approval or recognition of maintenance compounds

　　（1） The Director-General may approve or recognise maintenance compounds for use in particular areas of dairy processing, or for certain uses or equipment related to dairy processing.

　　（2） The Director-General may impose conditions on the use of maintenance compounds by specification or as part of an approval or recognition given under subclause （1）。

　　（3） Before making a decision under subclause （1）， the Director-General must assess—

　　（a） the risk that the maintenance compound may contaminate dairy material or dairy product; and

　　（b） the ability to control that risk through the application of conditions under subclause （2）。

　　31 Requirements relating to animals, and dairy material for dairy processing

　　（1） The Director-General may specify dairy processing requirements on primary producers, owners and suppliers of milking animals, and owners and suppliers of dairy material that is intended or provided for dairy processing in order to ensure the fitness for its purpose of the dairy material or dairy product.

　　（2） Specifications made under subclause （1） may include the following requirements:

　　（a） procurement and presentation requirements of milking animals or dairy material intended or provided for processing, including requirements relating to the provision or obtaining of information pertaining to the suitability of any dairy material for processing for human or animal consumption:

　　（b） requirements relating to animal feed and the quantity and quality of water available to milking animals to ensure the fitness for its purpose of the milk or dairy material.

　　（3） The obligations contained in specifications prepared under subclause （1） may apply generally or in relation to any particular class of producer, owner, supplier, or dairy material.

　　（4） Before making specifications under subclause （1）， the Director-General must be satisfied of at least 1 of the matters referred to in regulation 21.

　　（5） Where a person is unable to meet a requirement of specifications made under subclause （1）， the Director-General may, on application made before the relevant dairy material is presented for dairy processing, grant approval in writing for the dairy material to be presented and accepted for processing, if satisfied that—

　　（a） there is good reason in the special circumstances of the case why the requirements of the specifications cannot be met; and

　　（b） acceptance of the dairy material would not prejudice the fitness for its intended purpose of the resulting product.

　　（6） An approval under subclause （5） may be subject to conditions.

　　32 Identification, differentiation, and security systems and devices

　　（1） In this regulation, approved or specified system or device means a system or device approved or specified by the Director-General under section 158（1）（a） of the Act, and notified as such under section 167 of the Act, for the purposes of the identification,differentiation, or security of—

　　（a） milking animals, dairy material, or dairy products subject to the Act; or

　　（b） premises or places where such dairy material or products are or may be produced or processed, held, stored, or transported; or

　　（c） things of any nature that come or may come into contact with such dairy material or products, or may otherwise affect the suitability of the dairy material or the fitness for its intended purpose of the dairy product.

　　（2） A person who operates or applies an approved or specified system or device must,—

　　（a） if the Director-General also approves or specifies under section 158 of the Act the persons who may operate or apply the system or device, be a person who meets the requirements of the approval or specification; and

　　（b） comply with any conditions specified by the Director-General under section 158 of the Act on the acquisition, use, or security of the system or device.

　　（3） A person who is a manufacturer of an approved or specified system or device must comply with any requirements for manufacturers specified by the Director-General under section 158 of the Act as to the manufacture, transport, storage, sale, and security of the system or device.

　　33 Offences

　　（1） Failure to comply with any of regulations 4（1）， 4（2）， 5（1）， 6（1）， 7（1）， 8（1）， 9（1）， 10（1）， （2）， and（4）， 11, 12, 13（1）， 14, 15（1）， 16, 17（1）， 22, 23（1）， 24（1）， 25（1）， 26（1） and （2）， 27（1） and （2）， 29, and 32（2） and（3）， or with specifications made under or for the purposes of any of those regulations, constitutes an offence for the purposes of section 135（1）（b） of the Act.

　　（2） Any person who fails to comply with specifications made under or for the purposes of any of regulations 7（2）， 8（2）， 13（2），15（2）， 17（2）， 18, 19, 20, 27（3）， 28（2）， and 31 commits an offence.

　　（3） An offence under subclause （2） constitutes an offence for the purposes of section 135（1）（b） of the Act.