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Supplement quality assurance: ISO 22000, raw-material and batch testing

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 11 October 2026 · Reading time: 9 min

Legal obligations and voluntary certification

Under Directive 2002/46/EC, food supplements are foods. General food law therefore applies to their manufacture: food business operators at all stages of production, processing and distribution within the businesses under their control must ensure that food satisfies the requirements of food law and verify that those requirements are met (Article 17 of Regulation (EC) No 178/2002). Beyond these obligations, a manufacturer can choose to be certified to international standards.

The overview:

HACCP: the legal foundation

HACCP stands for Hazard Analysis and Critical Control Points. Article 5 of Regulation (EC) No 852/2004 requires food business operators working after primary production to put in place, implement and maintain permanent procedures based on these principles. The regulation lists seven principles:

1. Identify hazards that must be prevented, eliminated or reduced to acceptable levels.
2. Identify critical control points: the steps at which control is essential.
3. Establish critical limits at these points that separate acceptability from unacceptability.
4. Establish and implement monitoring at the critical control points.
5. Establish corrective actions for when a control point is not under control.
6. Verify regularly that the measures are working effectively.
7. Document – with documents and records commensurate with the nature and size of the business.

When the product, the process or any step changes, the procedure must be reviewed and adapted. For you, this means a new formula or a new raw material is also a reason to review the hazard analysis.

ISO 22000 and ISO 9001: what the certificates show

ISO 22000 sets requirements for a food safety management system and is aimed at any organization in the food chain – from ingredient producers to manufacturers and retailers. The standard combines four elements: interactive communication along the chain, system management, prerequisite programs (PRPs) for basic hygiene conditions and the HACCP principles. In other words, it builds on the legally required HACCP concept and embeds it in a management system that is planned, monitored and continuously improved.

ISO 9001 is the cross-industry standard for quality management systems. It sets out how a company manages its processes so that it can consistently provide products that meet customer and regulatory requirements.

Important for your assessment: certification is voluntary, and ISO itself does not certify – independent certification bodies do. A certificate is therefore only as meaningful as its details. Check:

• Validity: Is the certificate current?
• Site: Does it cover the facility where your product is actually made?
• Scope: Does it include the manufacture of food supplements – or only another part of the company?
• Issuer: Which certification body carried out the audit?

Which certifications Novogenia holds and what they stand for is shown on our quality assurance and certifications page.

Production environment: hygiene and cross-contamination

The prerequisite programs that ISO 22000 builds on govern the basic conditions of production: cleaning, personal hygiene, pest control, equipment maintenance and the separation of materials. For your product, one question matters most: what else is processed on the same equipment?

A manufacturer that processes allergen-containing ingredients or bacterial cultures, for example, has to prevent traces of them from getting into other products. The most effective approach is not to have such substances in the facility at all: where no allergens are processed, they cannot carry over from one formula to another.

Ask: What other substances are processed at the site? How is the equipment cleaned between two products, and how is that verified?

Raw-material testing and certificates of analysis

Every raw material comes with a certificate of analysis (CoA) from the supplier. It documents what was measured on that batch – typically identity, content, purity and microbiological values. A careful manufacturer does not rely on it alone but tests incoming raw materials itself before they go into production. What matters is that every batch is tested, not just the first delivery from a new supplier.

EU law expressly regulates one test point for food supplements as well: contaminants. Regulation (EU) 2023/915 sets, among other things, maximum levels for lead, cadmium and mercury in food supplements. Since such substances can enter the product through raw materials, controlling them is part of raw-material testing.

How to choose raw materials and which questions to ask is covered in Supplement raw materials.

Batch documentation and traceability

As a rule, a food may only be marketed with an indication that allows the lot – usually called the batch – to be identified (Directive 2011/91/EU). A lot is a batch of sales units produced, manufactured or packaged under practically the same conditions.

Then there is traceability under Article 18 of Regulation (EC) No 178/2002: food business operators must be able to identify who supplied them with a food or a substance intended for it and which businesses they have supplied with their products – and make this information available to the authorities on demand. In short: one step back, one step forward.

Good batch documentation goes further and internally links every product batch to everything that went into it. Typical contents:

• batch number and date of manufacture
• raw materials used, with their batch numbers
• results of raw-material and in-process checks
• testing and release of the finished product
• recipients of the batch

Why this matters to you: if a food does not comply with food safety requirements, Article 19 of Regulation (EC) No 178/2002 requires it to be withdrawn from the market immediately and the authorities to be informed. If the product may have reached consumers, they must be informed and, if necessary, the product recalled. With clean batch documentation, such a problem can be narrowed down to the batches affected.

Stability and best-before date

The date of minimum durability, or best-before date, is mandatory information (Article 9 of Regulation (EU) No 1169/2011). The regulation defines it as the date until which the food retains its specific properties when properly stored. For a food supplement, it is particularly important that the declared nutrient amounts are right – they are stated per portion recommended for daily consumption (Article 8 of Directive 2002/46/EC).

Some nutrients are sensitive to light, heat, moisture or oxygen, and their content can decrease during storage. That is why shelf life is justified with stability data: the product is stored under defined conditions and analyzed at intervals. Formula, raw-material form and packaging all influence the result.

The European Commission takes into account that measured contents never match the label exactly with a guidance document for control authorities on tolerances for declared nutrient values. It shows what the controls are based on.

Ask: How was the shelf life of my product justified? Does it also apply to the packaging I have chosen?

Quality throughout the project: what is checked when

Quality assurance is not a single test at the end; it accompanies your product through every phase:

1. Development: Are all substances and compounds permitted, are the doses within the safety limits, does the formula suit the dosage form?
2. Suppliers and goods-in: Suppliers are approved, and every incoming raw-material batch is tested.
3. Production: In-process checks at the defined control points, documentation of every batch.
4. Release: The finished product is tested and only then released.
5. After launch: Complaints are evaluated, stability data confirm the shelf life, and changes to raw materials or processes are assessed.

The documents you should request

Who is responsible for what?

Manufacturer and brand are each responsible for the stages under their control (Article 17 of Regulation (EC) No 178/2002). Whoever sells a supplement under their own name is responsible for the product and its labeling – even if a contract manufacturer produces it. So set out in the contract who handles what:

• Who releases batches, and which documents do you receive?
• How are customer complaints passed on and handled?
• Who informs authorities and retailers in an emergency – and how quickly?
• Who keeps which records, and for how long?
• Will you be informed if raw-material suppliers or processes change?

More criteria for choosing your partner are covered in How to choose a supplement manufacturer.

Frequently asked questions

Related: Quality assurance and certifications at Novogenia · Supplement raw materials · How to choose a supplement manufacturer

Note: This guide is general information and does not constitute legal advice. Regulations can change; errors and changes excepted. Always have legal questions about your specific product checked by a qualified expert.