5.1.1 The company shall provide clear guidelines on any restrictions to the scope of new product developments to control the introduction of hazards which would be unacceptable to the site or customers
This shall ensure that hazards have been assessed and suitable controls, identified through the HACCP system, are implemented. This approval shall be granted before products are introduced into the factory environment.
5.1.3 Trials using production equipment shall be carried out where it is necessary to validate that product formulation and manufacturing processes are capable of producing a safe product of the required quality.
5.1.4 Initial shelf-life trials shall be undertaken using documented protocols that reflect conditions expected during manufacture, storage, transport/distribution, use and handling to determine product shelf life.
Results shall be recorded and retained and shall confirm compliance with the relevant microbiological, chemical and organoleptic criteria/sensory analysis. Where shelf-life trials prior to production are impractical, for instance for some long-life produc
Product labelling shall comply with the appropriate legal requirements and contain information to enable the safe handling, display, storage and preparation of the product within the food supply chain or by the customer.
5.2.1All products shall be labelled to meet legal requirements for the designated country of use and shall include information to allow the safe handling, display, storage, preparation and use of the product within the food supply chain or by the customer
There shall be a process to verify that ingredient and allergen labelling is correct based on the product recipe and ingredient specifications
5.2.2There shall be effective processes in place to ensure that labelling information is reviewed whenever changes occur to:
the product recipe
the supplier of raw materials
the country of origin of raw materials
5.2.3 Where a product is designed to enable a claim to be made to satisfy a consumer group (e.g. a nutritional claim, reducedsugar), the company shall ensure that the product formulation and production process are fully validated to meet the stated claim.
5.2.3Where a product is designed to enable a claim to be made to satisfy a consumer group (e.g. a nutritional claim, reducedsugar), the company shall ensure that the product formulation and production process are fully validated to meet the stated claim.
5.2.4 Where the label information is the responsibility of a customer or a nominated third party, the company shall provide information:
to enable the label to be accurately created
whenever a change occurs which may affect the label information.
5.2.5Where cooking instructions are provided to ensure product safety, they shall be fully validated to ensure that, when the product is cooked according to the instructions, a safe, ready-to-eat product is consistently produced.
5.3 Management of allergens
The site shall have a system for the management of allergenic materials which minimises the risk of allergen contamination of products and meets legal requirements for labelling in the country of sale.
5.3.1 The site shall carry out an assessment of raw materials to establish the presence and likelihood of contamination byallergens (see glossary). This shall include a review of the raw material specifications and, where required, the acquisition of addi
5.3.2 The company shall identify and list allergen-containing materials handled on site. This shall include
5.3.3 A documented risk assessment shall be carried out to identify routes of contamination and establish documented policies and procedures for handling raw materials and intermediate and finished products to ensurecross-contamination (cross-contact) is
consideration of the physical state of the allergenic material (i.e. powder, liquid, particulate)
identification of potential points of cross-contamination (cross-contact) through the process flow
assessment of the risk of allergen cross-contamination (cross-contact) at each process step
identification of suitable controls to reduce or eliminate the risk of cross-contamination (cross-contact).
5.3.4Procedures shall be established to ensure the effective management of allergenic materials to prevent cross-contamination (cross-contact) of products not containing the allergen. These shall include, as appropriate:
physical or time segregation while allergen-containing materials are being stored, processed or packed
the use of separate or additional protective overclothing when handling allergenic materials
use of identified, dedicated equipment and utensils for processing
scheduling of production to reduce changes between productscontaining an allergen and products not containing the allergen
systems to restrict the movement of airborne dust containing allergenic material
waste handling and spillage controls
restrictions on food brought onto site by staff, visitors and contractor sand for catering purposes.
5.3.5 Where rework is used, or reworking operations are carried out, procedures shall be implemented to ensure rework containing allergens is not used in products that do not already contain the allergen.
5.3.6 Where a justified, risk-based assessment demonstrates that the nature of the production process is such that cross-contamination (cross-contact) from an allergen cannot be prevented, a warning should be included on the label. National guidelines or
5.3.7 Where a claim is made regarding the suitability of a food for allergy or food sensitivity sufferers, the site shall ensure that the production process is fully validated to meet the stated claim and the effectiveness of the process is routinely veri
5.3.8 Equipment or area-cleaning procedures shall be designed to remove or reduce to acceptable levels any potential cross-contamination (cross-contact) by allergens. The cleaning methods shall be validated to ensure that they are effective and the effect
Cleaning equipment used to clean allergenic materials shall either be identifiable and specific for allergen use, single use, or effectively cleaned after use.
5.4Product authenticity, claims and chain of custody
Systems shall be in place to minimise the risk of purchasing fraudulent or adulterated food raw materials and to ensure that all product descriptions and claims are legal, accurate and verified.
5.4.1 The company shall have processes in place to access information on historical and developing threats to the supply chain which may present a risk of adulteration or substitution of raw materials (i.e. fraudulent raw materials). Such information may
private resource centres.
5.4.2 A documented vulnerability assessment shall be carried out on all food raw materials or groups of raw materials to assess the potential risk of adulteration or substitution. This shall take into account:
historical evidence of substitution or adulteration
economic factors which may make adulteration or substitution more attractive
ease of access to raw materials through the supply chain
sophistication of routine testing to identify adulterants
the nature of the raw material
The output from this assessment shall be a documented vulnerability assessment plan.This plan shall be kept under review to reflect changing economic circumstances and market intelligence which may alter the potential risks. It shall be formally reviewed
5.4.3Where raw materials are identified as being at particular risk of adulteration or substitution, the vulnerability assessment plan shall include appropriate assurance and/or testing processes to mitigate the identified risks
5.4.4 Where products are labelled or claims are made on finished packs which are dependent on the status of a raw material, the status of each batch of the raw material shall be verified. These claims include:
specific provenance or origin
assured status (e.g. GlobalG.A.P.)
genetically modified organism (GMO) status
named specific trademarked ingredients.
The facility shall maintain purchasing records, traceability of raw material usage and final product packing records to substantiate claims. The site shall undertake documented mass balance tests at a frequency to meet the particular scheme requirements o
5.4.5Where claims are made about the methods of production (e.g. organic, halal, kosher) the site shall maintain the necessary certification status in order to make such a claim.
5.4.6 The process flow for the production of products where claims are made shall be documented and potential areas for contamination or loss of identity identified.
Appropriate controls shall be established to ensure the integrity of the product claims.
5.5 Utilities –water, ice, air and other gases
Product packaging shall be appropriate for the intended use and shall be stored under conditions to prevent contamination and minimise deterioration.
5.5.1 When purchasing or specifying primary packaging, the supplier of packaging materials shall be made aware of any particular characteristics of the food
which may affect packaging suitability. Certificates of conformity or other evidence shall be available for primary packaging to confirm it complies with applicable food safety legislation and is suitable for its intended use.
5.5.2Product liners and bags purchased by the company for use in direct contact with ingredients, or work in process, shall be appropriately coloured (e.g. contrasting colour to the product) and resistant to tearing to prevent accidental contamination.
5.5.3 The company shall have a procedure to manage obsolete packaging (including labels). This shall include:
mechanisms to prevent accidental use of obsolete packaging
control and disposal of obsolete packaging
appropriate procedures for the disposal of obsolete printed materials (e.g. rendering trademarked materials unusable).
5.6 Product inspection and laboratory testing
The company shall undertake or subcontract inspection and analyses which are critical to confirm product safety, legality, integrity and quality, usingappropriate procedures, facilities and standards
5.6.1 Product inspection and testing
22.214.171.124There shall be a scheduled programme of product testing which may include microbiological, chemical, physical and organoleptic testing according to risk. The methods, frequency and specified limits shall be documented.
126.96.36.199 Test and inspection results shall be recorded and reviewed regularly to identify trends. The significance of external laboratory results shall be understood and acted upon accordingly.
Appropriate actions shall be implemented promptly to address any unsatisfactory results or trends.
188.8.131.52 The site shall ensure that a system of validation and ongoing verification of the shelf life is in place.
This shall be based on risk and shall include sensory analysis and, as applicable, microbiological testing and relevant chemical factors such as pH and aw. Records and results from shelf-life tests shall verify the shelf-life period indicated on the produ
5.6.2 Laboratory testing
5..6.2.1 Pathogen testing (including pathogens tested as part of the environmental testing) shall be subcontracted to an external laboratory or, where conducted internally, the laboratoryfacility shall be fully segregated from the production and storage a
184.108.40.206 Where routine testing laboratories are present on a manufacturing site, they shall be located, designed and operated to eliminate potential risks to product safety. Controls shall be documented, implemented and include consideration of:
design and operation of drainage and ventilation systems
access and security of the facility
movement of laboratory personnel
protective clothing arrangements
processes for obtaining product samples
processes for obtaining product samples
220.127.116.11 Where the company undertakes or subcontracts analyses which are critical to product safety or legality, the laboratory or subcontractors shall have gained recognised laboratory accreditation or operate in accordance with the requirements and princ
Documented justification shall be available where accredited methods are not undertaken.
18.104.22.168 Procedures shall be in place to ensure reliability of laboratory results, other than those critical to safety and legality specified in clause 22.214.171.124. These shall include:
use of recognised test methods, where available
ocumented testing procedures
ensuring staff are suitably qualified and/or trained and competent to carry out the analysis required
se of a system to verify the accuracy of test results (e.g. ring or proficiency testing)
use of appropriately calibrated and maintained equipment
126.96.36.199The significance of laboratory results shall be understood and acted upon accordingly.
Appropriate action shall be taken promptly to address any unsatisfactory results or trends.
Where legal limits apply, these shall be understood and appropriate action taken promptly to address any exceedance of these limits
5.7 Product release
The site shall ensure that finished product is not released unless all agreed procedures have been followed.
5.7.1 Where products require positive release, procedures shall be in place to ensure that release does not occur until all release criteria have been completed and the release has been authorized.
5.8 Pet food
The site shall ensure that pet food products are safe and fit for intended use.
5.8.1 The site shall ensure pet food is formulated/designed for the intended use (e.g. where products are designed for complete diet or as a complementary product).
5.8.2 Where a site’s product range includes pet food products for different animal species, the site shall have specific procedures for the management of any ingredients, raw materials, products or rework that could be harmful to unintended recipients.
5.8.3Where the site manufactures, processes or packs pet food products that contain medicinal substances, the site shall have specific procedures for the management of the medicated raw materials and finished products. At a minimum, these procedures shall
identification of medication-containing materials handled on site. These can be raw materials, processing aids, intermediate and finished products, rework or any new product or product development ingredients
mechanisms to ensure the correct concentrations of medicinal substances in finished products
procedures (e.g. cleaning procedures) to prevent contamination of non-medicated pet food with materials containing medicinal substances
specific procedures to ensure the correct labelling of medicated pet food.