1. General monitoring requirements

The requirements listed in this document are in addition to those set out in the R1.0 Feed Safety Management Requirements document.

1.1. Monitoring plan

Information (like EWS, RASFF or other signals about possible hazards) that might influence the established monitoring plan must be assessed. If necessary, the monitoring plan must be adapted immediately.

The GMP+ certified company may make use of representative monitoring results from other companies (for example: suppliers). This particularly applies to monitoring results for undesirable substances where the level theoretically speaking no longer changes, such as heavy metals, pesticides, dioxin.

Note: ‘representative’ does not necessarily mean: ‘from the delivered batch’.

If there is any doubt, uncertainty or unclearness about the representativeness of the monitoring results from other companies, the certified company must verify on the representativeness.

The GMP+ certified company must determine if specific monitoring requirements described in this document are applicable and must therefore be implemented in the monitoring plan of the certified company.

In case of overlap between different monitoring requirements in this document or other GMP+ FSA documents, the GMP+ certified company must apply the strictest monitoring requirements.

1.2. Monitoring frequency

The monitoring frequency must give assurance that all identified hazards and determined risks remain under control.

The GMP+ certified company must follow the minimum monitoring frequencies as established in the monitoring protocols in this document. If the hazard analysis shows that additional monitoring is needed, the GMP+ certified company must increase the monitoring frequency in accordance with the result of the hazard analysis.

1.3. Sampling

Unless the monitoring protocols in this document state otherwise, the GMP+ certified company must take samples in accordance with the requirements as laid down in document TS 1.6 Sampling.

1.4. Analysing

1.4.1. Analysis method

The analysis must be carried out by a laboratory approved for this under the GMP+ FSA module. See TS 1.2 Purchase.

1.4.2. Sharing analysis results

The results of the analyses that are carried out within the framework of applying the monitoring protocols in this document must be uploaded in the GMP+ Monitoring database. The analysis results must be uploaded within a month from the date of issuance of the Certificate of analysis and shared anonymously with the GMP+ Community in the GMP+ Monitoring database.

1.5. Collective monitoring plan

It is possible for GMP+ certified companies to carry out their monitoring plan together (in a collective monitoring plan). The following requirements must be applied with respect to this option:

1. The collective monitoring plan must comply with the GMP+ requirements..
2. The scope of the monitoring plan must be established (‘which feed is included’) and which companies are participating.
3. The collective monitoring plan must be representative for the feed which the manufacturers produce, trade, treat and / or process. Its representativeness must be motivated.
4. All the participating companies must obtain all the relevant sampling and monitoring results.

2. Monitoring protocol of Aflatoxin B1 in Maize and By-products of maize

2.1. General requirements

2.1.1. Scope

This protocol gives specific requirements for sampling and analysing Aflatoxin B1 in:

• maize, processed or unprocessed and
• by-products of maize,

which will be delivered in the GMP+ chain. It applies to all maize harvests.

The monitoring requirements in this protocol must be applied either to the maize or to the maize by-product.

2.1.2. Application

This protocol applies to the GMP+ certified company which trades or processes the products as mentioned in § 2.1.1.

The producer of the maize by-product must apply the protocol to the end product. Food producing companies that purchase and process maize under the conditions of Regulation (EU) No. 2023/915 (maximum levels for contaminants in foodstuff) are allowed to apply the protocol to the incoming flow of maize if they have a motivation in writing of the concentration factor in the production process and also do a risk-based monitoring on the maize by-product.

If a batch of maize or a maize by-product has already been analysed by a GMP+ certified supplier, this batch is not required to be analysed again. This is also applicable when the supplier is participating in another, accepted feed safety assurance scheme, under the condition that the analysis results are available.

2.1.3. Countries of cultivation

The countries of cultivation* of maize are classified into 3 categories: High, Medium and Low. Sampling and analysis of maize from a high risk country must be performed in accordance with the requirements in § 2.2.1.

Maize from a Medium risk country must be sampled and analysed in accordance with § 2.2.2. For Low risk countries, sampling and analysis must be in accordance with § 2.2.3.

To consult the classification of countries of cultivation click here.

The country of cultivation of the maize must always be known to every link in the supply chain, and the customer must be informed, including the end user.

2.1.4. Place of sampling

Batches must be sampled at loading (country of cultivation) or at discharge (country of delivery). In case the protocol is applied at discharge, the batch is determined by the means of transport in which the maize or maize by-product is then loaded.

2.1.5. Sample preparation

The GMP+ certified company applying this protocol must send at least a 4 kg sample of maize (by-product) to the laboratory for preparation and analysis. The preparation and analysis by the laboratory must be in accordance with the following conditions:

1. The sample must be fully grinded and homogenized before the final sample and out of it the sample for analysis must be taken.
2. The final sample must at least be 500 grams.
3. The sample for analysis must be prepared from the final sample.
4. The remains of the final sample must be retained for re-analysis.

2.1.6. Analysing

2.1.6.1. Analyse method

The sample for analysis must be analysed on Aflatoxin B1.

2.2. Requirements per classification of countries of cultivation

2.2.1. High risk countries

2.2.1.1. Application

For maize from high risk countries, the first link in the chain is responsible for a correct application of this protocol.

2.2.1.2. Monitoring frequency

Each final sample must be analysed.

2.2.1.3. Size of batches

The batch size of maize or maize by-product is related to the means of transport and must have common characteristics, such as origin, variety, type of packing, packer, consignor or labelling.

2.2.1.4. Sampling

2.2.1.4.1. Sampling method

The sampler must take representative samples in accordance with the described in Regulation (EC) No. 152/2009, including the amendments regulated by Regulation (EU) No. 691/2013, under the following conditions:

1. sampling must be undertaken of the whole batch. Sampling of part of the whole batch is not acceptable within the framework of this protocol;
   If the whole batch in the warehouse is not accessible for sampling, a sampling plan must be made and retained as documented information. The sampling plan must cover the accessible part of the batch. The part of the batch that has not yet been sampled and monitored, must be monitored once it´s possible and safe to get access;
2. each aggregate sample must not be less than 10 kg;
3. the sample to be send to the laboratory for preparation and analysis must not be less than 4 kg. See § 2.1.5 and 2.1.6 for requirements regarding sample preparation and analysis by the laboratory.

In case of direct ship-to-ship transshipment (from a seagoing vessel, coaster, inland waterway vessel to an inland waterway vessel) the method described in “GAFTA sampling rules No. 124” is allowed under the following conditions:

4. a representative sample must be taken during loading or unloading of the means of transport.
5. at least 20 incremental samples per 500 tons and at least 40 incremental samples for batches smaller than 1,000 tons.
6. maximum volume of the incremental sample: 1kg
7. minimum 20 kg per (sub)batch of 500 tons
8. at least 1 final sample, which shall not be less than 4 kg. Each final sample must be fully grinded and made homogeneous by the laboratory. See § 2.1.5 and 2.1.6 for requirements regarding sample preparation and analysis by the laboratory.

Note : In cases where maize is stored longer than 3 month in a silo and is not accessible for

sampling before delivery to the customer, sampling may be carried out during loading. The

results must be available before unloading at the customer or at least before the next processing step or feeding (if there is a written agreement between the seller and the customer).

2.2.1.4.3. Sample taker

Each batch must be sampled by an independent superintendent organization accredited according to:

1. ISO 17020 for an appropriate scope, or alternatively;
2. ISO 9001 for an appropriate scope in combination with a GAFTA* approval as superintendent for sampling in a relevant application domain (e.g. Animal feed).

2.2.1.4.4. Other requirements

The period between sampling and delivery must not be longer than three months.

It is possible to separate a batch at a storage location in the country of cultivation within the framework of direct transport per inland waterway vessel, train or truck to the end user. The following additional requirements apply:

1. The batch must be kept in quarantine (separate and identifiable) at the storage location in the country of cultivation.
2. The location must be set up in such a way that representative (cross-section) samples can be taken.

2.2.1.4.5. Information to the Client and End user

Positive release: The analysis results (by means of a certificate of analysis issued by an accredited organization (see § 2.2.1.4.2) or an analytical report issued by a GMP+ Registered laboratory,) must accompany the batch, so each link in the chain is informed.

The end user must be informed about the results of the analysis that have been carried out before using or processing the maize or maize by-product in feed.

There must be a clear link between the delivered batch and the certificate of analysis / analytical report from an approved laboratory (positive release). The information must demonstrate that the sampling was conducted not longer than 3 months before the date of delivery.

In case of stored batches and re-analysis after 3 months, the highest measured Aflatoxin B1 value (from all sampling moments) is leading since it is not obvious that Aflatoxin B1 content could decrease over time. All analysis results applicable for the batch (also the expired results) must accompany the batch.

In case of maize by-products, the food producing company must declare in writing that he has applied the protocol to the incoming flow of maize.

2.2.2. Medium risk countries

2.2.2.1. Application

For maize from medium risk countries, the first link in the chain is responsible for a correct application of this protocol.

Only in case of direct delivery with trucks, the receiving company (in most cases the compound feed company) is responsible for correct application of this protocol.

In case of an end user receives maize from a Medium country by truck it is possible to process this maize

• In dairy feed, only after results of analysis are available.
• In all other feed, the results do not necessarily have to be available before processing. These results can be received later.

Note: This requirement may be different by another scheme. In those case, the first link in the chain is responsible for applying the protocol.

2.2.2.2. Monitoring frequency

Each final sample must be analysed.

2.2.2.3. Size of the batches

All batches must be sampled and analysed, whereby the batch of maize or maize by-product is related to the means of transport and must have common characteristics, such as origin, variety, type of packing, packer, consignor or labelling.

2.2.2.4. Sampling

2.2.2.4.1. Sampling method

The sampler must take representative samples in accordance with the method described in Regulation (EC) No. 152/2009, including the amendments regulated by Regulation (EU) No. 691/2013, under the following conditions:

1. sampling must be undertaken of the whole batch. Sampling of part of the whole batch is not acceptable within the framework of this protocol.
   If the whole cargo in the warehouse is not accessible for sampling, a sampling plan must be made and retained as documented information. that the sampling plan must cover the accessible part of the cargo. The part of the cargo that has not yet been sampled and monitored, must be monitored once it´s possible and safe to get access.
2. each aggregate sample must not be less than 10 kg.
3. the sample to be send to the laboratory for preparation and analysis must not be less than 4 kg. See § 2.1.5 and 2.1.6 for requirements regarding sample preparation and analysis by the laboratory.

In case of direct ship-to-ship transshipment (from a seagoing vessel, coaster, inland waterway vessel to an inland waterway vessel) the method described in “GAFTA sampling rules No. 124” is allowed under the following conditions:

4. a representative sample must be taken during loading or unloading of the means of transport.
5. at least 20 incremental samples per 500 tons and at least 40 incremental samples for batches smaller than 1,000 tons.
6. maximum volume of the incremental sample: 1kg
7. minimum 20 kg per (sub)batch of 500 tons
8. at least 1 final sample, which shall not be less than 4 kg. Each final sample must be fully grinded and made homogeneous by the laboratory. See § 2.1.5 and 2.1.6 for requirements regarding sample preparation and analysis by the laboratory.

Note : In cases where maize is stored longer than 3 month in a silo and is not accessible for

sampling before delivery to the customer, sampling may be carried out during loading. The

results must be available before unloading at the customer or at least before the next processing step or feeding (if there is a written agreement between the seller and the customer).

2.2.2.4.3. Sample taker

For medium risk countries, each batch must be sampled by an independent superintendent organization accredited according to:

1. ISO 17020 for an appropriate scope, or alternatively:
2. ISO 9001 for an appropriate scope in combination with GAFTA* approval as superintendent for sampling in a relevant application domain (e.g. Animal feed).

In case of the direct transport by truck as described above, sampling can be performed and controlled by the GMP+ certified company in compliance with the requirements in document TS 1.6 Sampling, instead of the sampling rules as mentioned above.

2.2.2.4.5. Other requirements

The period between sampling and delivery must not be longer than three months.

It is possible to separate a batch at a storage location in the country of cultivation within the framework of direct transport per inland waterway vessel, train or truck to the end user. The following additional requirements apply:

1. The batch must be kept in quarantine (separate and identifiable) at the storage location in the country of cultivation.
2. The location must be set up in such a way that representative (cross-section) samples can be taken.

2.2.2.4.7. Information to the Client and end User

Positive release: The analysis results (by means of a certificate of analysis issued by an accredited organization (see § 2.2.2.4.2) or an analytical report issued by a GMP+ Registered laboratory must accompany the batch, so each link in the chain is informed.

The end user must be informed about the results of the analysis that have been carried out before using or processing the maize or maize by-product in feed (excluding deliveries by truck).

There must be a clear link between the delivered batch and the certificate of analysis / analytical report from an approved laboratory (positive release). The information must demonstrate that the sampling was conducted not longer than 3 months before the date of delivery.

In case of stored batches and re-analysis after 3 months, the highest measured Aflatoxin B1 value (from all sampling moments) is leading since it is not obvious that Aflatoxin B1 content could decrease over time. All analysis results applicable for the batch (also the expired results) must accompany the batch.

In case of maize by-products, the food producing company must declare in writing that he has applied the protocol to the incoming flow of maize.

2.2.3. Low risk countries

2.2.3.1. Application

For maize from low risk countries, every GMP+ certified company is responsible for a correct application of this protocol, based on HACCP principles.

2.2.3.2. Monitoring frequency

Final samples must be analysed based on a hazard analysis.

2.2.3.3. Size of the batches

The batch of maize or maize by-product is related to the means of transport and must have common characteristics, such as origin, variety, type of packing, packer, consignor or labelling .

2.2.3.4. Sampling

2.2.3.4.1. Sampling method

The sampler must take representative samples in accordance with the requirements as described in document TS 1.6 Sampling.

2.2.3.4.3. Sample taker

Sampling must be done, in accordance with the requirements as laid down in document TS 1.6 Sampling.

2.2.3.4.5. Information to the client and end user

All links in the chain, including the end user, must be informed (on request) periodically about the analysis results and receive a summary or overview of the results of the application of this protocol.

In case of maize by-products, the food producing company must declare in writing that he has applied the protocol to the incoming flow of maize.

3. Monitoring protocol of Salmonella in feed

3.1. General requirements

3.1.1. Scope

This protocol contains minimum monitoring requirements for Salmonella in feed.

Excluded from this scope are feed products in which Salmonella cannot survive due to the intrinsic properties of the feed products: the pH value, temperature and/or low water activity (Aw-value). The exclusion must be based on a documented validation.

3.1.2. Application

This protocol applies to the GMP+ certified company that:

• produces feed, or
• outsources the production of feed to another company. See TS 1.2 Purchasefor the requirements for purchasing production or processing on a contract basis.

If responsibilities with regard to the application of this monitoring protocol are transferred to another company, this must be kept as documented information.

3.2. Monitoring frequency

The GMP+ certified company must ensure that the feed does not exceed the Salmonella limits, as laid down in TS 1.5 Specific feed safety limits.

The ongoing effectiveness of the control measures must be monitored in accordance with the below-mentioned minimum monitoring frequencies. Monitoring is done by analysing representative samples taken of the end-products as close as possible to the end of the production line.

3.2.1. Compound feed for poultry

The GMP+ certified company that produces compound feed for poultry must sample and analyse the compound feed according to the monitoring frequency as specified in the following table:

*The validation must be kept as documented information.

3.2.2. Compound feed (except feed for poultry)

The GMP+ certified company that produces other compound feed than those intended for poultry must sample and analyse the compound feed at least once per 10,000 tons.

3.2.3. Feed materials

The GMP+ certified company that produces feed materials must sample and analyse each feed material according to the monitoring frequency as specified in the following table:

*The validation must be kept as documented information.

3.2.4. Feed additives and premixtures

The GMP+ certified company that produces feed additives or premixtures must sample and analyse the feed additives and premixtures based on HACCP.

3.3. Analysing

Salmonella-positive results must be serological classified. See R 1.0 Feed Safety Management Systems Requirements for the requirements on how to handle non-conform products.

4. Monitoring protocol of animal protein

4.1. General requirements

4.1.1. Scope

This protocol contains minimum monitoring requirements for tissue proteins from mammals in compound feed, including wet mixes, for ruminants.

4.1.2. Application

This protocol applies to the GMP+ certified company that produces compound feed, including wet mixes, for ruminants.

4.2. Monitoring frequency

Monitoring is done by analysing the samples taken of end-products on the presence of tissue proteins from mammals in accordance with the below-mentioned minimum frequency:

5. Monitoring protocol of Oils and Fats as regards dioxin and dioxin like PCB’s

5.1. General requirements

5.1.1. Scope

This protocol provides specific requirements* for monitoring the levels of dioxin and dioxin-like PCB’s in oil and fat products, which

1. originate from the processing of oil seed, oil refining, animal fat processing and/or fat blending, and;
2. are used in feed, and;

are produced, traded, stored, transported or used by GMP+ certified companies.

5.1.2. Application

This monitoring applies to GMP+ certified companies that produce or trade the products mentioned under § 5.1.1.

GMP+ certified companies are exempt from monitoring if they dispose of an analysis result, covering the purchased batch (unique reference of the batch must be included in the analysis report).

5.2. Monitoring frequency

It is important to highlight that the monitoring frequencies, as is specified in the following tables, are not meant to substitute the individual feed business operator’s HACCP system, and do not exempt a feed business operator from applying the HACCP principles, which includes the establishing of an adequate monitoring plan. This monitoring plan must, at least, include the minimum monitoring frequency laid down in the following tables as follows:

The labeling of feed materials that fall under this monitoring must – where possible – use the names listed in Regulation (EU) no. 68/2013 (European Catalogue of feed materials).

Such a name ensures that the product is identified with certainty and to determine the monitoring (class 1, 2, 3 or 4) to which this feed material has been subjected with maximum precision.

In case the name used is not included in Regulation (EU) no. 68/2013, only monitoring conform product class 1 (forbidden products) or product class 2 can be applied.

Class 3 or class 4 monitoring can only be applied for products of which the name is included in the European Catalogue of feed materials and for which a product class 3 or 4 has been identified in the tables above.

The monitoring must be carried out in accordance with the class as specified in the table below:

Note: Instead of monitoring incoming batches according to these classifications, a fat blender may choose to monitor 100% of outgoing batches (= class 2). This choice needs to be declared to the auditor. EU-located feed business need also to declare the choice to the competent authority.

5.3. Positive release

To comply with the Positive Release requirements, GMP+ certified companies (producers and, if appropriate, traders, see § 5.1.2) within the supply chain, may use several systems. In this section, a number of systems, are explained. These systems are allowed to be used by GMP+ certified companies, active within the supply chain. However, if the competent authority, or a customer, has additional requirements, these must also be satisfied.

The analysis results of dioxins and dioxin-like PCBs must be available, before any use in feed materials such as compound feed and premixtures.

Note: with ‘shipped’ is meant that the product is transported from the producer’s facility to (for example) a storage tank, located at the customer’s facility. The producer, still owns the product and is therefore responsible for the product. With ‘delivered’ is meant that the product is not only transported to the customer, but also the ownership of the product is transferred to the customer.

*Example 1 to 4b: positive release not necessary in case the blend consists for 100% out of Acid Oils.

6. Monitoring protocol for By-products of the oils and fats industry

6.1. General requirements

6.1.1. Scope

Any product derived directly or indirectly from crude or recovered oils and fats by oleochemical or biodiesel processing or distillation, chemical or physical refining, other than:

• refined oils,
• products derived from refined oils,
• feed additives,

to be used in feed, from any origin.

The next products are out of scope:

1. products, produced by an EU registered food operator
2. crude or pure distilled fatty acids (13.6.6/13.6.7) derived from vegetable oil (2.20.1)
3. products derived from fatty acids, covered under b

Note: See Appendix 1 for more details about products in scope of this protocol.

6.1.2. Application

This protocol must be applied by GMP+ certified companies that:

• produce by-products (mentioned in 6.1.1) from the oil and fat industry.
• Trade / import by-products (mentioned in 6.1.1) from the oil and fat industry.

This protocol is not applicable for GMP+ certified companies that produce compound feed which is to be delivered to a livestock farmer.

6.2. Definitions

6.3. Monitoring frequency

Batch by batch, 100% positive release. Batches/lots must be monitored before used in feed. Producer of the by-product is responsible unless agreed (in contract or another official document) to transfer this responsibility for monitoring to his customer. They must also agree that results are shared. Representative monitoring results need to accompany any delivered batch, also to customers.

6.4. Sampling

When shipped by sea vessel or barge

• Shipment to be carried out under a well-known, in the international trade accepted contract (FOSFA, NOFOTA, GROFOR) to assure

• Independent supervision
• Sampling per lot
• Safe previous cargoes and technical equipment

• When shipped by vehicles (tank/container):

• Sampling of each truck

6.5. Analysing

The below mentioned parameters must be analysed

• Fatty Acid profile
• Moisture and impurities
• Free Fatty Acid
• Dioxins, dioxin-like PCBs, non-Dioxin-like PCBs
• Pesticides
• Heavy metals (Arsenic, Cadmium, Mercury, Lead and Nickel)
• Mineral oil hydrocarbons (C10-C40)
• PAH’s

6.5.1. Information to the client

Information, which is generated as a result of application of this Appendix, must be unambiguous and must accompany every batch / shipment to demonstrate that requirements have been met.

Appendix 1: Product name and Number according to Reg. (EU) No 68/2013

Explanation

( 1 ) The name must be supplemented by the species.

( 2 ) The name must be supplemented by the plant species.

( 3 ) The name must be supplemented by the indication of the botanical or animal origin.

( 4 ) The name must be amended or supplemented to specify the fatty acids used

( 5 ) The name must be amended or supplemented to specify the organic acid.

¹¹ This product is out of scope of § 6 only in case produced/derived from fatty acids covered under 13.6.6 or 13.6.7, which are in their turn obtained by splitting of vegetable oil falling under the Catalogue of feed materials number 2.20.1.

¹² The products 13.6.6 and 13.6.7 are out of scope of § 6 only in case the feedstock used to produce these products is vegetable oil falling under the Catalogue of feed materials number 2.20.1. When other products are used as the feedstock,, the products 13.6.6 and 13.6.7 are within scope of § 6.

Feed Support Products

That was a lot of information to digest and one might ask, what is the next step? Luckily we can offer support for the GMP+ Community when doing this. We provide support by means of various tools and guidances but as each company has a shared responsibility to feed safety, and therefor tailor-made solutions cannot be offered. However, we do help by explaining requirements and provide background information about the requirements.

We have developed various supporting materials for the GMP+ Community. These include various tools, ranging from Frequently Asked Questions (FAQ) lists to webinars and events.

Supporting materials related to this document (Guidelines and FAQ’s)

We have made documents available which give guidance to the GMP+ requirements as laid down in the module GMP+ FSA and GMP+ FRA. These documents give examples, answers to frequently asked questions or background information.

GMP+ Monitoring database

The GMP+ Monitoring database contains analysis results from you and other users. It is possible to generate reports based on this data. We have a manual and a frequently asked questions document available.