ISO 5509 — Standard

About the Standard

Scope title: preparation of fatty acid methyl esters from fats

ISO 5509 is a standard published by International Organization for Standardization (ISO). The international standards organisation; it publishes the widest body of management system, test method and product standards.

See the other 310 codes from ISO

Food Testing — What Does This Testing Field Cover?

The section below describes the field that code ISO 5509 belongs to; it is not the text of the standard or the regime itself. The scope title of the code is given above, and technical requirements are shared at the quotation stage.

Food testing shows that a product is safe for consumption and contains what its label states. The family works along three axes: microbiological safety, chemical safety and nutritional composition. All three require different laboratory infrastructure, a different body of methods and a different turnaround time.

The most distinctive feature of the field is TIME PRESSURE. A steel specimen can wait on a shelf; a raw milk or fresh meat sample cannot. The time the sample was taken, the transport temperature and how long it takes to reach the laboratory directly determine the validity of the result. In food microbiology the cold chain record is therefore an inseparable part of the test report.

On the microbiological side there are two different questions and they must not be confused. DETECTION of a pathogen is a qualitative question: is Salmonella present in the sample or not? ENUMERATION of indicator organisms is a quantitative question and an indicator of production hygiene. The absence of a pathogen in a product does not show that hygiene is good; if the total mesophilic aerobic count is high, there is a problem in the process.

On the chemical side, pesticide residues, mycotoxins, heavy metals, additives, veterinary drug residues and process contaminants (acrylamide, furan, PAH) are measured. Multi-residue methods in this area (QuEChERS-based LC-MS/MS and GC-MS/MS) can screen hundreds of active substances in a single analysis; limits are defined separately for each product–substance pair.

On the composition side, protein, fat, moisture, ash, fibre, sugar profile, fatty acid composition, vitamin and mineral content are determined. These values are the basis of the nutrition declaration on the label and the tolerance ranges are defined in legislation — the difference between the declared value and the measured value must stay within that tolerance.

There is NO CE marking on food, and this shapes how the field works. Conformity is demonstrated through operating a HACCP-based food safety system, complying with labelling rules and not exceeding contaminant, residue and microbiological limits. A test result produces evidence not for a certificate but for a functioning system.

Allergen management carries particular weight. The presence of an undeclared allergen in a product is one of the most frequent causes of food recalls. Analysis here runs together with cleaning validation: it is shown that the line has been cleaned adequately after a production run containing an allergen and that the risk of cross-contamination is under control.

Voluntary schemes have become effectively mandatory in this field. Retail chains require their suppliers to hold a certificate under a GFSI-recognised scheme (BRCGS, IFS, FSSC 22000); without it, getting onto the shelf is practically impossible.

Method groups in this field

Pathogen detection
Detection of Salmonella, Listeria monocytogenes, Campylobacter, Cronobacter and Shiga toxin-producing E. coli; culture-based and molecular methods.
Indicator counts
Total mesophilic aerobic count, Enterobacteriaceae, coliforms and E. coli, coagulase-positive staphylococci, yeasts and moulds, lactic acid bacteria, sulphite-reducing Clostridia.
Pesticide and veterinary residues
Multi-residue screening by LC-MS/MS and GC-MS/MS with QuEChERS extraction.
Mycotoxins and contaminants
Aflatoxins, ochratoxin A, deoxynivalenol, patulin; heavy metals (ICP-MS), acrylamide and PAH compounds.
Nutritional composition
Kjeldahl protein, fat and fatty acid profile, moisture, ash, dietary fibre, sugar profile, vitamin and mineral analyses.
Allergens and authenticity
Gluten, milk, egg, nut and soy allergen analyses; molecular methods for species identification and adulteration detection.

Commonly confused in this field

Sampling is half the result. A sample transported at the wrong temperature or delayed gives an invalid result even if it is analysed correctly in the laboratory.
The absence of a pathogen does not show that hygiene is good; indicator counts give separate information and the two are read together.
A result from a sample taken from a lot can be generalised to the whole lot only if the sampling plan was set up statistically.
Limits are defined in separate regulations by product group and are updated regularly; a conformity decision based on an outdated limit table may be wrong.
For exports, the limits of the destination country may differ from EU limits; the same product may be compliant in one market and non-compliant in another.

Which decisions these results support

Verification of the HACCP plan and process monitoring
The basis for the nutrition declaration and allergen information on the label
Health certificates before export and compliance with destination market limits
Supplier and lot-based acceptance control
Shelf-life studies and determining storage conditions
Producing evidence for audits under GFSI-recognised schemes

Structure of the Code

Published by: ISO
Serial number: 5509
Part: without partition

Codes in the library without release year is kept. The current version changes over time; If the year is specified in your specification, that version is taken as basis, if not specified, the most current version is applied.

Scope

Food Testing

Related Tests and Services

A separate test page based on this code has not yet been released. The code falls within the scope of the following test families.

Food Testing

Technical Requirements

Standard texts are copyright of the relevant organization; test condition, sample and acceptance criteria cannot be fitted here.

Technical requirements specific to your product, once we clarify the scope At offer stage shared in writing.

Relevant Product Groups and Legislation

This code is included in the standard tag of the product pages below.

These product pages carry notes for the following markets: European Union, United Kingdom, USA. Whether the standard is mandatory in the relevant market varies depending on the product group and the applicable legislation.

Regulations published with this code on the same product pages:

(AB) 2018/858Vehicle Type-Approval FrameworkApproval of motor vehicles and their components. Component and separate technical unit approval run under this framework; the E mark arises from it.
UNECEUNECE 1958 AgreementType-approval under component-specific UNECE regulations (e.g. R10 EMC, R30/R54 tyres, R43 glazing).
UNECE R10UNECE R10Electromagnetic compatibility approval for vehicles and their components.
2011/65/EURoHSRestriction of hazardous substances in electrical and electronic equipment.
2000/53/ATELVEnd-of-life vehicles. Sets heavy-metal restrictions and recoverability targets.
(EU) 2017/745MDRThe Medical Device Regulation. Classification (I, IIa, IIb, III), clinical evaluation, technical documentation and post-market surveillance obligations; the notified body's role grows as the class rises.
(EU) 2017/746IVDRThe In Vitro Diagnostic Medical Devices Regulation. In vitro diagnostic devices fall under this regulation instead of the MDR.
(AB) 2017/745 art. 33EUDAMEDThe European medical device database. From 28 May 2026, the actor registration, UDI/device, certificate and market surveillance modules are mandatory; placing on the market is not possible without a valid SRN.
2006/42/ATMachinery Directive (overlap)Relevant essential requirements also apply to medical devices that also qualify as machinery.
(EC) 1907/2006REACHRegistration, evaluation, authorisation and restriction of chemicals; SVHC notification.
(EU) 2023/1230Machinery RegulationReplaces 2006/42/EC and becomes mandatory on 20 January 2027 with no further transition period. Requires notified-body involvement for Annex I high-risk machinery.
2014/35/EULVDThe Low Voltage Directive. Governs electrical safety in the 50–1000 V AC range.
2014/30/EUEMCThe Electromagnetic Compatibility Directive. Emission and immunity are covered together.
2014/34/ABATEXEquipment and protective systems used in explosive atmospheres. The category and conformity route are determined by zone classification.
2000/14/ATNoise EmissionNoise emitted into the environment by outdoor equipment. Machinery within scope requires a sound-power-level declaration and marking.
2014/68/EUPEDThe Pressure Equipment Directive for pressurised parts; the category is determined by pressure and volume.
(EU) 2024/573F-GasRefrigerant type, GWP value and leak-tightness obligations for systems containing a refrigerant.
(AB) 547/2012Ecodesign (water pumps)Ecodesign requirements for water pumps. Sets minimum efficiency index and product-information requirements.
(AB) 2019/1781Ecodesign (electric motors)Efficiency class requirements for electric motors and variable-speed drives.
(AT) 1935/2004Food Contact MaterialsGeneral requirements for equipment in contact with food; material conformity is required for valves in food lines.
(AB) 2020/2184Drinking Water Contact ProductsHygiene requirements for materials in contact with water under the Drinking Water Directive.
2014/29/ABSimple Pressure VesselsA separate directive for series-produced simple pressure vessels; its scope must be distinguished from the PED.
2010/35/ABTransportable Pressure EquipmentThe pi mark and periodic inspection regime for transportable pressure equipment.
2009/48/ECToy SafetyThe Toy Safety Directive. Regulates mechanical, physical, flammability, chemical and electrical safety requirements together; a technical file and safety assessment are mandatory.
EN 62115Electrical toysSafety for electric toys; applies to mains-connected or battery-powered toys.
(AT) 1907/2006 Annex XVII item 51-52Phthalate RestrictionRestriction of certain phthalates in toys and childcare articles.
(EU) 2023/1542Batteries RegulationBattery obligations and a removability requirement for toys containing a battery.
(AB) 1007/2011Textile LabellingTextile fibre names and labelling. Declaration of fibre composition and regulation of the label language.
(AT) 1907/2006 Annex XVII item 43Azo Dye RestrictionRestriction of certain azo dyes in textiles in contact with skin.
(AB) 2019/1021PFAS / PFOA RestrictionRestriction of PFOA and its derivatives under the Persistent Organic Pollutants Regulation.
(EU) 2023/988GPSRThe General Product Safety Regulation. The safety framework for consumer products not covered by sector-specific legislation.
(EU) 2016/425Personal Protective Equipment (overlap)The PPE Regulation's scope and category are determined for textiles with a protective function.
(AB) 10/2011Plastics in Food ContactPlastic materials in contact with food. The list of authorised substances, and overall and specific migration limits.
(AT) 2023/2006Good Manufacturing PracticeGood manufacturing practice (GMP) for food-contact materials.
(AB) 2025/40Packaging and Packaging WasteThe Packaging and Packaging Waste Regulation. Recyclability, recycled-content and packaging-reduction obligations; replaces 94/62/EC.
(AB) 2022/1616Recycled PlasticRecycled plastic materials in contact with food.
(EU) 2024/3110Construction Products RegulationDeclaration of performance and CE marking for construction products. Most provisions apply from 8 January 2026; it progressively replaces (EU) 305/2011.
(AB) 305/2011CPR (transition)Continues to apply during the transition period for product groups where a new harmonised standard has not been published.
EN 13501-1Reaction-to-Fire ClassificationReaction-to-fire class for construction products; a mandatory item of the declaration of performance.
(EU) 2023/1115Deforestation (wood-based)A deforestation-free supply declaration for wood and derived construction materials.
(AT) 1223/2009Cosmetic Products RegulationThe Cosmetic Products Regulation. Appointing a responsible person, the product information file (PIF), the safety assessment (CPSR) and CPNP notification are mandatory; there is no product approval, and responsibility rests with the manufacturer.
(AT) 1223/2009 Annexes II-VIProhibited and Restricted SubstancesLists of prohibited substances, restricted substances, and permitted preservatives, colorants and UV filters.
(AT) 1223/2009 art. 16Nanomaterial NotificationA separate notification six months before placing on the market for products containing nanomaterials.
(AT) 1223/2009 art. 18Animal Testing BanA ban on animal testing of finished products and ingredients, and on placing animal-tested products on the market.
(AT) 178/2002General Food LawThe general principles of food law, traceability and food safety responsibility.
(AT) 852/2004Food HygieneHygiene rules for food businesses and the obligation for a HACCP-based system.
(AB) 1169/2011Food Information to ConsumersFood labelling; nutrition declaration, allergen information and origin information.
(AB) 2023/915ContaminantsMaximum levels of contaminants in food.
(AT) 396/2005Pesticide residuesMaximum residue limits in food of plant and animal origin.
(AT) 2073/2005Microbiological CriteriaMicrobiological criteria for foodstuffs.

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Frequently Asked Questions

Is this standard mandatory for my product?

Whether it is mandatory depends on the product group, the target market and the applicable legislation. Once you tell us your product and market, we clarify in writing whether this standard is required.

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