Information sheet 64 English Translation

Control of relevant hazards associated with the procurement of food (including raw materials) in the context of HACCP

Infosheet 64: The General Food Regulation (GMM, Article 17 of Regulation (EC) No 178/2002) requires food business operators to ensure that, at all stages of production, processing, and distribution, food under their control complies with the requirements of food law applicable to their business operations and to verify that these requirements are effectively complied with. This general obligation has been reiterated in Article 3 of Regulation (EC) No 852/2004 on the hygiene of foodstuffs.

Furthermore, this Regulation lays down detailed rules for food business operators. Article 5 of this Regulation requires food business operators to implement HACCP procedures to ensure food safety. Operators shall identify any hazards that need to be prevented, eliminated, or reduced to acceptable levels. Based on hazard analysis, they must identify critical control points (CCPs) in their business process, including procurement and distribution, at all stages where control is essential to prevent or eliminate a hazard or reduce it to an acceptable level. These CCPs must be demonstrably controlled (with monitoring and verification, among other things). For a detailed description of the HACCP principles, see the website of the Dutch Food and Consumer Product Safety Authority (NVWA).

Information sheet 64 and Article 5

Article 5 of this Regulation requires food business operators to implement HACCP procedures to ensure food safety. Operators shall identify any hazards that need to be prevented, eliminated or reduced to acceptable levels. This Factsheet focuses on the hazards of raw materials/foodstuffs purchased by food business operators that are not eliminated by the company’s process/HACCP plan, by preventing the purchase of raw materials/foodstuffs containing these hazards, this danger is controlled. With this Information Sheet, the Dutch Food and Consumer Product Safety Authority has drawn up guidelines on how food business operators can control the relevant hazards of purchased raw materials/foodstuffs.

Food business operators may deviate from the proposed procedure in this Factsheet if they can argue to the satisfaction of the competent authority (during an inspection) and demonstrate that the alternatives they propose offer at least the same guarantees and the same level of food safety.

This Fact Sheet 64 is structured as follows:

• Paragraph 2 contains a number of definitions;
• Paragraph 3 explains the scope and responsibilities;
• Paragraph 4 describes the general principles of hazard analysis and hazard management;
• Paragraph 5 describes the different steps that make up hazard analysis and hazard control;
• Annex 1 contains the information to be included in a certificate of analysis or the test report;
• Annex 2 contains a schedule of the control measures.

Information sheet 64 Definitions

For the purposes of this Factsheet, the following definitions set out in Article 3 of the General Food Regulation (EC) No 178/2002 shall be used:

• Food company;
• food business operator;
• retail trade;
• placing on the market;risk;hazard;
• stages of production, processing, and distribution; and
• end user

Table 1 summarizes the further definitions used in this Factsheet.

Table 1. Definitions Fact sheet 64

Concept	Definition
Stakeholder	An identifiable and demarcated quantity of food produced, manufactured, or packaged under substantially identical conditions and marketed under the same batch code. (Based on: Art. 1 Commodities Act Decree on food information)
Producer/ Processor/ private label holder	Operator producing, preparing or handling food. A producer can sell his product under his own brand/name (trademark) or under the brand of a retailer (private label). (Based on: Art. 2 Regulation (EC) No. 765/2008)\ Please note: a ‘private label holder’ is seen as a producer of the product or bears the same responsibility as a producer.
Private label product	Product produced under a (trade) mark of a third party.
Distributor/ Dealer	Operator in the supply chain, other than the producer or importer, who deals in food and makes it available on the market. (Based on: Article 2 Regulation (EC) No 765/2008)
Merchant B2B (‘business-to-business’)	Supply chain operator dealing in raw materials/semi-finished products and ingredients supplied to food businesses. Food businesses use these raw materials and ingredients to produce their own food. For example, a distributor of oils in bulk that is further processed or a trader in pre-cooked potatoes that are processed into a salad.
Importer	A natural or legal person established in the European Community who places a product from a third country on the Community market. (Art. 2 Regulation (EC) No 765/2008)
Supplier	The operator who supplies food (including raw materials/ semi-finished products) to his customer (customer). A supplier can be a processor/producer, distributor/trader, or importer.
New supplier	A supplier, where the intention is to qualify it as a regular supplier, who delivers for the first time or after a longer delivery break of 1 year (for deliveries with an explainable interval of more than 1 year, such as for seasonal products, a longer delivery break can be used. Provided that it can be demonstrated that processes/raw materials have not changed in relevant respects).
Regular supplier	A supplier that can demonstrably be labeled as ‘reliable’ on the basis of good substantiation.
Changing supplier	A supplier that is usually engaged on an ad hoc basis (e.g. if a fixed supplier cannot deliver on time), with no prospect of establishing a permanent trading relationship.
Hazard analysis	Identifying any hazard (hazard identification) that needs to be prevented, eliminated or reduced to an acceptable level (choice of relevant hazards). (Based on: Article 5 Regulation (EC) No 852/2004)
Risk assessment	The likelihood of an adverse health effect and the severity of that effect resulting from the hazard identified. In other words: Probability x Severity = Risk.
Relevant hazards	Hazards arising from the hazard analysis for which food safety control measures must be adopted.
Hazard control	Take measures necessary to prevent, control or reduce a relevant hazard to an acceptable level.

Scope and responsibilities information sheet 64

The scope of this Factsheet shall apply to all stages of the production, processing, and distribution of food, as well as to exports and imports, in so far as the process is covered by Regulation (EC) No 852/2004.

Table 2. Food business operators and their hazard control responsibilities.

Table 2 gives an overview of the different food operators (including raw materials) and their responsibilities, depending on their activities in the chain.

Operator	Products	Responsibilities
Producer/ Processor	Own brand (trademark)	Identify all hazards and control the relevant hazards of its raw materials/products.
	Brand of (retailer) dealer (private label holder)	Identify all hazards and control the relevant hazards of its raw materials/products. The trademark owner is ultimately responsible and makes specific agreements with the producer about the control of the relevant hazards and checks whether they are complied with.
Distributor/ Dealer/ Retailer	Food intended for B2B	Identify, control and verify the relevant hazards of its products.
	Food intended for final consumers and mass caterers	Identify the relevant hazards, make specific agreements with the producer/processor about the control of the relevant hazards and check whether the agreements are being complied with. Hygiene codes are available for certain sectors in which the purchasing process is described.
Importer		Identify all hazards and control the relevant hazards of its raw materials, semi-finished products and/or finished products imported from non-EU countries. In addition, an importer is responsible for ensuring that products comply with European and Dutch laws and regulations upon entry into EU territory.

General principles of hazard analysis and hazard control

In order to achieve control of hazards in the chain, each operator (link) in the chain must know the relevant hazards of the products and raw materials, make agreements about this with the supplier and check compliance with the agreements.

The starting points for a method of hazard analysis and hazard control are:

• operators identify and control all relevant hazards;
• the operator shall make specific arrangements with the supplier on the control of those hazards and these shall be recorded in writing. Having a product specification or declaration, data from the producer, traceability and complaint registration can be part of the agreements;
• the operator checks that the agreements are being fulfilled. In fact, this is about the reliability of the supplier. As verifiable trust in the supplier grows, the degree of control may decrease. The system is dynamic, which means that experiences and new insights can lead to adjustments in the approach;
• the operator has incorporated the working method into its own food safety system (or works with a hygiene code) and identifies and controls relevant hazards that may arise after receipt of the products (e.g. by cold chain control, expiry date monitoring).

Hazard analysis and control

In order to carry out the hazard analysis and hazard control, the following steps must be followed, which are further explained in this section: – identification of all hazards, including risk determination (assessment based on likelihood x severity);
– choosing relevant hazards;
– control relevant hazards.

Identification and risk assessment of all hazards

The food business operator must make an overview of all raw materials and products. You can choose to group certain raw materials and/or products. For all raw materials/products or groups, all possible microbiological, chemical, or physical hazards that can reasonably be expected at any stage (including the purchase and storage of raw materials and products) shall be identified.

Risk assesment

An operator can carry out the hazard identification of its products based on knowledge about the product, scientific literature, sector knowledge, monitoring data, general food safety insights, past incidents, legal maximum limits/levels and limit values, raw material hazards database, etc. A risk assessment is then made on the basis of the likelihood of an adverse health effect and the severity of that effect resulting from the identified hazard. In other words: Likelihood x Severity = Risk.

Knowledge sources

The operator can use knowledge about the sector, general insights into food safety, knowledge about the product and the producer, monitoring data, past incidents and recalls, European food safety alerts (via the so-called RASFF system), etc.vFor the severity assessment, use can be made of newsletters, professional literature, websites, scientific literature, and the like. Please note: the severity may differ for different target groups (for example for children or the elderly, depending on the sales channel, this must be taken into account).

Risk assessment according infosheet 64

This risk assessment indicates whether the hazard is relevant and needs to be controlled. The likelihood must be estimated realistically and must always be up-to-date. The effect of any subsequent process steps (e.g. cooking) is not yet taken into account in this step (see also 5.2). 

Choosing relevant hazards according to info sheet 64

The operator then identifies the relevant hazards for the product/raw material(s) based on the risk. In the context of food safety, these hazards must be controlled.

As mentioned in section 5.1, the determination of the relevant hazards is based on the sources mentioned, in particular, the “historical data”. For example, radioactivity is a relevant hazard in raw materials coming from an area where incidents at nuclear power plants have been detected; Certain pesticides are a relevant hazard in products from specific countries where deviations from pesticide residues are regularly detected during (national and/or international) studies.

Please note: the control of the relevant hazards in the process of the company itself may NOT be part of the risk assessment or it may NOT be included in the process of likelihood x severity determination. First, a relevant hazard is identified and only then is it described how the hazard is controlled. For example, a pasteurization process to control relevant microbiological hazards should not be included in the risk assessment. The microbiological hazards should be identified and identified as relevant. Therefore, the pasteurization step is described as a control step. 

Control of relevant hazards according to info sheet 64

In the case of raw material/product (groups) where relevant hazards are identified, control measures will have to be taken. These are almost always control measures that must be taken by the producer or supplier. There is the possibility that control measures are not taken by the supplier of the raw material, but by the processor of the raw material. In that case, a clear agreement must be made between them. For example, the risk assessment shows that salmonella in sesame seeds is a relevant danger. If a meal producer adds sesame seeds to his products, the producer must check how this relevant hazard is controlled by the supplier, but can also choose to control this danger himself by means of a process step (e.g. heating). The producer makes agreements with the supplier about this.

The supplier’s control does not relieve the producer/processor or the trader or importer of the responsibility to carry out a hazard analysis on the raw materials and/or the trading products.

Analysis data available from sectoral monitoring programs such as National Plan, Food Compass, NZO, etc. may be used to substantiate hazard identification and risk determination. However, these data are not sufficient to prove that the relevant hazards have been controlled and should not be the only form of control.

For the control of these relevant hazards in the raw materials and products, the NVWA accepts at least the following control measures or combinations thereof:

1. The supplier of the raw material shall provide each party with a valid certificate (so-called Certificate of Analysis or CoA) of an independent investigation showing that the supplied raw material/product meets the legal requirements for the intended use and may be used as food. The CoA should include the hazards identified in the hazard analysis to demonstrate that these risks have been reduced or eliminated. Legal requirements have been laid down for certain products, parameters, reference or analytical methods and/or certificates, for example in Regulation (EC) No 1881/2006 for chemical contaminants, Regulation (EC) No 2073/2005 with microbiological criteria, Regulation (EC) No 396/2005 with maximum residue limits for pesticides and Regulation (EC) 2017/2158 for acrylamide.

An analysis must be batch-specific and must be carried out in a laboratory accredited according to the international standard ISO/IEC 170253 for the analysis carried out. The result of the analysis shall be reported by the laboratory in accordance with the criteria laid down in standard ISO/IEC 17025. See Annex 1 of this Factsheet for more information on the certificate of analysis or the test report.

2. If the supplier of the raw material does not provide a certificate of analysis, the customer must carry out the analysis of the relevant hazards of the supplied batches himself. In addition, a certificate of analysis from the supplier, as the sole source of control, is not in all cases sufficient to control the relevant hazards. For example, certain foods, such as peanuts, may experience hazards that only arise during or after transport. In this case, all relevant hazards cannot be controlled exclusively with a certificate of analysis from the supplier from the country of origin and the customer will also have to carry out its own verification on the supplied batches. It is up to the company to determine whether this is the case in its situation. Where the customer carries out the analyses himself, the same criteria as described in point 1 or criteria of at least comparable level shall apply.

As trust in the supplier grows, the number of analyses to be carried out can be reduced. The reliability of the supplier must be demonstrable. This can be done through good analysis results, supplier assessments, complaint analysis, etc.

In the case of new suppliers, at least the first 5 delivered batches per product group are analyzed for the relevant hazards of the raw materials/foodstuffs. The product groups are determined in a risk-oriented manner with the same relevant hazards, taking into account the origin of the products.

With good analysis results per product group of the first delivered batches, the supplier can be labeled as a ‘regular supplier’ of this product group. The number of analyses to be carried out on this product group can then be reduced to ‘√n’ where ‘n’ stands for the number of batches delivered on an annual basis, with a minimum number of analyses per product group of 1 per year (see schedule Annex 2 fixed supplier). If analytical results are different, the customer must take adequate measures and (temporarily) increase the frequency of analysis again (the next 5 batches delivered per product group are examined again, see schedule Annex 2 new supplier). When the same raw material or product is delivered by different suppliers, each supplier is of course treated separately according to the above method.

Where deliveries include several product groups (with controlled hazards) from a single supplier, it may be sufficient to carry out rotational sampling of a part(√n) after it has been established that it is a permanent supplier, with a minimum number of analyses of 1 per year per product group, so that all product groups are sampled. If this supplier supplies several production sites, the sampling of the different locations together can be seen as √.

3. Companies can carry out an audit at their supplier (or have it carried out) by a demonstrably trained auditor4. This audit must then at least focus on the adequate control of the relevant hazard in the raw materials or products concerned. The audit report shall include at least the following items: – the hazard of the raw material/product concerned;
– the way in which this hazard is managed in the company, including the methodology used;
– the corrective measures; and
– the final verdict and the agreements made.

This audit is carried out risk-oriented with a minimum frequency of 1 time every 3 years. For new suppliers, the audit is carried out prior to the first delivery.

4. The supplier is certified by a private quality system accepted in Ketenborging.nl with the control of hazards of raw materials/commercial products specifically mentioned in the scope/scope. During such an audit, specific attention is paid to the control of raw material hazards and it is tested that all raw materials are assessed and the hazards are demonstrably controlled.

In addition, food safety certificates accepted on Ketenborging.nl with a general scope (including the control of raw material hazards) are also considered sufficient provided that 1) the control for all raw materials/products has been assessed during the audit and 2) that the points mentioned under point 3 above are described in the audit report. In this case, a company must demonstrate by means of a report that an assessment has been carried out on the raw materials/products in question and that all relevant hazards have been demonstrably controlled (in practice, however, there is generally only limited attention to this within the audit for certification for these systems and there is, therefore, no guarantee that all raw materials will actually be assessed). For more information, see the NVWA website Quality Systems (control systems) and Supervision NVWA.

The above possibilities are summarised in the diagram in Annex 2. The performance of hazard analysis and control is a dynamic process and should be evaluated at least annually.

Attachments information sheet 64

Annex 1: Analysis certificate or Trial report

A certificate of analysis or test report shall comply with the requirements of the ISO/IEC 17025 standard. The results of any test or analysis carried out by the laboratory shall be reported accurately, clearly, unambiguously and objectively. All information necessary for interpretation shall be included in the certificate of analysis or report.

A certificate of analysis or test report shall contain at least the following information:

• the name and address of the laboratory, and the location where the test or analysis was carried out, if different from the address of the laboratory,
• unambiguous indication of the analysis or method used and indication of accreditation of the laboratory based on the ISO/IEC 17025 standard for the analysis or method applied and date and body of issue;
• a unique identification of the certificate of analysis or test report;
• name and address of the sponsor of the analysis;
• name, position, and signature or equivalent identification of the person who released the certificate of analysis or report;
• description and identification of the product under investigation;
• date of receipt of the product to be examined and date or dates on which the examination or test was carried out;
• results of the analysis or test with, where appropriate, an indication of the units of measurement and uncertainty of measurement; and
• information from sample preparation and/or sampling where relevant for the interpretation of the results

Annex 2: Schedule and control measures

Annex 2 will be available soon

Source information sheet 64

This translation is based on the Dutch ‘Informatieblad 64’

https://www.nvwa.nl/documenten/consument/eten-drinken-roken/levensmiddelenketen/publicaties/informatieblad-64-borging-van-voedselveiligheid-in-de-levensmiddelenketen

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