Food products: why a declaration starts with HACCP

Food products are the only large category where conformity assessment almost never starts with a visit to the certification body. It starts at the production site: until procedures based on the HACCP principles are in place, there is nothing on which to adopt a declaration. This is the main difference between TR CU 021/2011 and the regulations for clothing or electronics, and it is where newcomers most often stumble.

What falls under the regulation

TR CU 021/2011 “On safety of food products” applies to all food products put into circulation in the territory of the Union, and also to the processes of their production, storage, transport, sale and disposal. It covers raw materials, finished products and public catering, as far as processes are concerned.

It is important that 021 almost never works alone. It is a framework regulation: it sets the general safety requirements and the rules of conformity assessment, and you must look for the specific indicators for your product in the product-specific regulations.

The practical conclusion: the list of regulations for one can of preserves often has three or four items, and the declaration is adopted for all of them at once. If you miss one of them, you get a document that formally does not cover the whole product.

The form of assessment: why it is a declaration

For the great majority of food products, the regulation provides for declaration of conformity and not for certification. The difference is basic: the declaration is adopted by the applicant itself, and the applicant itself is responsible for the accuracy of the data in it. The certification body does not issue a document to you. You declare conformity under your own responsibility, and the test reports serve as the evidence.

From this follows something that many learn too late: the responsibility for the content of the declaration lies entirely with the applicant. If a test report was obtained for a sample that does not represent the serial product, the laboratory will not be the one to answer.

Some categories of food products are taken out of declaration and placed under state registration. These are specialized products: baby food, food for athletes, dietary therapeutic and preventive food, dietary supplements, and mineral water of some categories. A state registration certificate is issued for them, and a declaration does not replace it.

Declaration schemes

The scheme decides what exactly is the evidence and who carries out the tests.

For serial production, 1d or 3d is used most often. Scheme 6d is attractive because it relies on a certified food safety management system, but this means a prior certification of the management system, which is a separate project with its own terms.

A declaration for serial production is issued for up to five years. No term is set for a batch: the document is valid exactly as long as this batch exists.

HACCP: without it the declaration has no basis

Article 10 of the regulation requires the manufacturer to develop, implement and maintain procedures based on the HACCP principles when it carries out production processes. The wording is important: the regulation does not require an ISO 22000 certificate and does not require you to “implement HACCP” as a purchase of documents. It requires working procedures.

In practice this means the following minimum.

• A description of the product and of the technological process. A complete flow chart from the acceptance of raw materials to shipment, with all stages shown.
• An analysis of hazards. Biological, chemical and physical, for each stage, with an assessment of the probability and the severity of the consequences.
• The determination of critical control points. The stages at which a hazard can be prevented or reduced to an acceptable level.
• Critical limits for each CCP. Specific measurable values: temperature, time, acidity.
• Monitoring and records. Who measures, how often and with what, and where the result is recorded.
• Corrective actions. What the operator does when a limit is breached and what happens to the products.
• Verification and traceability. A check that the system works and the ability to trace a batch in both directions.

The inspecting body looks not at whether a folder exists but at the records: whether the logs are filled in every day, whether the data match reality, and what happened on the day when the temperature went outside the limit. A set of documents printed a week before the inspection is recognized at once.

Which tests you will have to pass

The specific list depends on the product, but the structure is almost always the same.

Shelf life is a separate topic. If you set the shelf life yourself and do not take it from a standard in force, you must justify it by storage studies. This is not a formality: a shelf life that is declared “by eye” is one of the typical claims during control.

Labelling under TR CU 022/2011

Labelling is checked most often, because no laboratory is needed for it; it is enough to pick up the package. The mandatory information is:

• The name of the product, which reflects its nature and not only the brand
• The composition in order of decreasing mass fraction, with allergens highlighted
• The quantity of the product
• The date of manufacture and the shelf life, and the storage conditions
• The name and location of the manufacturer, and the person who accepts claims
• Recommendations for preparation, if the product cannot be used without them
• Indicators of nutritional value
• Information about GMO, if they are present
• Unified circulation mark of the EAEU (EAC)

Allergens need a separate mention: they are stated regardless of the quantity if they were used in production. Wording such as “may contain traces” does not remove the need to state what is really in the formulation.

Products of animal origin: an additional circuit

Meat, milk, fish, eggs and products made from them are subject to veterinary control in addition to technical regulation. This is a separate system with its own requirements: the production site must be attested, and the products are accompanied by veterinary accompanying documents that are issued in electronic form.

In practice this means that the enterprise goes through two independent procedures: one under technical regulation (the declaration) and the other under the veterinary line (attestation of the site and electronic veterinary certification). A declaration does not replace veterinary documents, and the reverse is also true.

The normative document for the product

Before you select samples, you need to answer the question: what exactly must your product conform to? There are two options: to work to an interstate or national standard in force, or to develop your own document, that is, technical specifications or an organization standard.

Working to a standard in force is simpler: the requirements are already stated, the indicators are known, and the laboratory understands what to measure. But the standard sets strict limits on the formulation and the name. As soon as the product goes beyond them, for example when you make condensed milk with a milk fat substitute, you cannot work to the standard for condensed milk, and you will have to change the name of the product as well.

Your own technical specifications give freedom in the formulation, but you must set yourself the quality and safety indicators, the control methods, the acceptance rules, the storage conditions and the shelf life. This is a document that both the laboratory and the inspector will read later, so its wording must be measurable. You can read more about what such a document contains in the article on technical specifications.

Importing food products

In imports the scheme changes in details, not in substance: a declaration is still needed, and the applicant is the importer or the person who performs the functions of the foreign manufacturer and is registered in the Union.

• The contract with the manufacturer. It confirms the applicant’s right to act in respect of these products and is usually requested when the documents are issued.
• The specification and the formulation. A foreign producer is not always ready to disclose the composition in full, and this becomes an obstacle: without the formulation it is impossible to assess conformity or to choose the test indicators.
• Relabelling. A Russian label with all the mandatory information is applied before the product is put into circulation. Sticking it on in a warehouse after a request from a buyer is a violation and not a solution.
• Importing samples for tests. To carry out studies before the main delivery, samples are imported separately, and you must include this step in the schedule.

A separate difficulty is the conformity of the foreign formulation with the requirements of the Union. Food additives that are permitted in the country of production may not be permitted here, or may be permitted in other concentrations. Check the composition before you sign the contract and not after the test results.

Traceability and product recall

The regulation requires traceability: for any unit of product, it must be possible to restore the chain from the raw material supplier to the buyer of the batch. This is not an abstract requirement. The recall procedure is built on it.

If a non-conformity is found, the manufacturer must stop production, withdraw the products from circulation and give notice of this. The practical value of traceability is that it decides the scale of losses: with good records, a specific batch is recalled, and without records, the whole volume for the period.

• Incoming control of raw materials, recording the supplier and the batch number
• Assigning numbers to batches of finished products, linked to the raw materials
• Recording of shipments, stating which batch went to whom
• Keeping the records for the set period
• A drill to check that the scheme works, at least once a year

Typical mistakes in documents for food products

The first two rows give more than half of all claims, and they are found in a minute: it is enough to compare the text of the declaration with the label. The other typical slips in documents are covered in a separate article.

How long the preparation takes

The exact terms depend on the product, but it is useful to understand the order of magnitude in advance, so that you do not set a launch date earlier than the documents can physically be ready.

The most underestimated item is shelf life studies. A shelf life of six months can be confirmed in less than six months only by accelerated methods, and they cannot be used for every product. Plan the launch of a product with a long shelf life with this in mind.

Steps for a new production

• Determine the full list of applicable regulations: 021 plus the product-specific ones plus 022 and 005
• Check whether the product is a specialized one; then state registration is needed and not a declaration
• Develop the normative document for the product: an organization standard or technical specifications, if you do not work to a standard in force
• Put the prerequisite programmes at the production site in order
• Develop and implement procedures based on the HACCP principles, and start keeping records
• Justify the shelf life by storage studies
• Select samples and carry out tests in an accredited laboratory
• Prepare the labelling layout and check it against regulation 022
• Adopt the declaration and register it in the FGIS register

The order here is not arbitrary. Tests before HACCP is implemented are a common mistake: the test report is obtained, but it is too early to adopt the declaration, because the evidence is incomplete.

Registration of the declaration

The declaration is registered in the FGIS register of Rosaccreditation in electronic form and is signed with the applicant’s qualified electronic signature. A paper form with a body’s stamp is an outdated practice: the entry in the register has legal force and not the printout. Anyone can check any document by its number, including your buyer and the marketplace.

The applicant can be the manufacturer, the seller or a person who performs the functions of the foreign manufacturer and is registered in the Union. For imported products this is usually the importer, and the importer is responsible for the data in the declaration.

What is checked after the product is put into circulation

An adopted declaration does not close the question forever. State control checks that the products match what was declared: it takes samples in retail, compares the labelling and asks for HACCP records. If the products do not conform, the declaration can be recognized as invalid, and the products must be withdrawn from circulation.

A separate risk is a change of the formulation or of the raw material supplier without a review of the documents. Formally the declaration remains valid, but in fact it describes a different product. Any change of composition, technology or packaging is a reason to check whether it is time to issue the documents again.