D-24 Positive Release & Specific Product Requirements

Overview of Revisions

Introduction

SecureFeed imposes additional requirements on certain products. These requirements apply to products with a difficult to manage risk, or products for which hazard assurance within the regular certification schemes is considered insufficient to maintain SecureFeed's intended assurance level. These are the Specific Product Requirements (SPR).

SPR occur in the form of Positive Release and/or additional conditions such as those relating to origin, extra monitoring requirements, sampling, etc.

• Positive Release, see Annex 1
• Additional conditions, see Annex 2, 3, 4 and 5

Application

Specific Product Requirements apply to products:

• as listed in the Annexes to this document,
• which, in whole or in a share higher than 25%, are processed into mixtures / compound feeds, delivered to SecureFeed participants. Conditions in this document concerning analyses can be applied to the raw material or the compound feed/premixture.

It does not matter what the blending ratio of the products in question is at the SecureFeed participant.

The Specific Product Requirements are binding; they must be complied with at all times before products may be supplied to a SecureFeed participant.

The suppliers and the products supplied must comply with the applicable EU legislation and regulations and with the requirements in the GMP+ Feed Safety Assurance scheme (www.gmpplus.org) or an equivalent quality assurance system for feed safety.

In addition, the SecureFeed action and rejection limits apply, which can be found in the handbook see document D-01 Action and rejection limits (www.securefeed.eu).

Laboratory

Analyses will be conducted by laboratories accredited for the determination of the contaminant specified in the relevant product matrix in accordance with ISO/IEC 17025 and certified in accordance with GMP+ (2010) B10 Laboratory Testing or GMP+(2020) TS 4.1 (or equivalent). Laboratories should also comply with GMP+ (2020) BA11 or GMP+(2020) TS 4.2 for the contaminants for which they are defined.

Analyses

In addition to the analyses mentioned in this document, all analyses prescribed by GMP+ FSA and EU regulations should also be carried out.

Dioxins and dioxin-like PCBs must be determined by a method based on GC-HRMS or GC-MS/MS or a minimally comparable method.

Definitions

Positive Release

In the context of SecureFeed, Positive Release means the following:

The analysis results with respect to the product-contaminant combinations mentioned in the annexes must be available and attached, and they must comply with the requirements mentioned in annex 1, before the product may be used in animal feed, such as compound feed and pre-mixes. All different options for Positive Release which have been worked out in paragraph 2.2.4 of GMP+ (2010) BA4 or GMP+(2020) TS 1.7 are acceptable to SecureFeed.

In the case of a composite batch, the analyses of all the constituent parts must comply with the set standards. No re-analysis of the composite batch is required in the context of Positive Release.

Additional Conditions

Additional conditions are extra conditions on top of the action and rejection limits set by SecureFeed.

Products subject to additional conditions may only be used as feed (raw) material if the product complies with the additional conditions set.

The additional conditions apply to 3 product groups:

• Fats, oils and by-products (Annex 2)
• Fish and fish products (Annex 3)
• Egg products (Annex 4)
• Animal byproducts (Annex 5)

Batch

A batch is an identifiable quantity of feed with common characteristics, such as origin, type, packer, sender or labelling; and, in the case of a production process, a unit of production from a business which uses uniform parameters in its production or a number of such units, which are produced and stored together in immediate succession. (Reg. (EC) No 183/2005, Annex II)

Method

Products subject to Positive Release or to additional conditions must demonstrably comply with the conditions listed in the annexes of this document before the batch can be released for processing or delivery to a SecureFeed participant. If the product is sold from participant to participant, the results only need to be directly retrievable. There must be a contract for this.

If the action limit is exceeded, the product may be delivered to a SecureFeed participant, but the SecureFeed participant must be informed. If the rejection limit is exceeded, the product is unfit for use as a feed material and may NOT be supplied to a SecureFeed participant.

Verification

During participant audits, supplier- and/or producer audits, carried out on behalf of SecureFeed, compliance with the Specific Product Requirements is verified.

Annex 1: Positive Release

A Positive Release applies to the products listed below. To some products deviating conditions also apply (Annex 1A).

¹ These norms apply in case of single delivery to dairy farmers. For processing in dairy cattle feed the following applies: Action limit: 0,0025 mg/kg; Rejection limit: legal rejection limit. For other target animals no positive release applies.

² Concerning Rice protein concentrate organic, Lineseed and Lineseed organic, the deviating conditions apply concerning analysis obligations and sampling as included in Annex 1A.

³ The origin is the country of cultivation, i.e. origin of the sunflower seed.

Annex 1A: Deviating conditions concerning analysis obligations and sampling

Deviating conditions for Rice protein concentrate, organic

• Sampling is performed upon delivery in Europe / the Netherlands, whereby the sampling must be representative of the entire batch. In the event of delivery in big bags, the number of sub-samples shall be at least the square root of the number of big bags in the import delivery.
• In addition to the identifications required by schemes, the certificate of analysis shall indicate the country of production of the rice protein concentrate and the size of the sampled lot.

Deviating conditions for Linseed and Linseed organic

• The following provisions apply to deliveries from a seagoing vessel:
• Sampling by seagoing vessels must always be done on the basis of FOSFA.
• One certificate of analysis per sea-going vessel is available.
• The results of analyses are known for delivery or processing; SF participant requests them. The analysis is representative for all parties of the ocean vessel and is final, so analysis by the buyer is not necessary.
• The following provisions apply to deliveries from a lorry in intermediate storage at the supplier's premises:
• Sampling and analysis per sample of several lots up to a maximum of 350 tonnes.
• A total of 14 subsamples shall be taken; at least one per lorry. The final sample is 600 g.
• The batches are not stored separately in the meantime.
• The results of analyses are known before delivery or processing; SF participant requests them.
• The sample analysis is representative for all batches covered by the sample and is final, so analysis by the customer is not necessary.

Annex 2: Additional product conditions: fats, oils and by-products

The additional product conditions for fats, oils and by-products apply to the following products:

These conditions do not apply to fish oil and products based on fish oil. These are listed in Appendix 3: Supplementary product conditions for fish and fish (by-)products.

* European Feed Material Register

Geographical origin

There are no geographical restrictions for fats, oils and by-products.

Raw materials

Vegetable: all vegetable derived products are allowed, with the exception of:

• Deodistillates (unprocessed / processed) from chemical refining and its derivatives

Labelling and freight documents

Each delivery of a batch is accompanied by a copy (digital/paper) of the original certificate of analysis for the named contaminants and therewith:

• The botanical and/or animal origin(s) of the product. In case of composite products, these origins shall be given in descending order by weight.
• The EU catalogue number(s) in accordance with Regulation (EU) 68/2013 of the feed materials in the batch.

The mentioned information may also be included on the freight documents or communicated in writing to the SecureFeed participant prior to delivery.

Monitoring

Positive Release

All described products for the determination of dioxins and the sum of dioxin and dioxin-like PCBs are subject to Positive Release.

Annex 3: Additional product conditions: fish(by-)products

The additional conditions for fish(by-)products apply to the following products:

Geographical origin

To all animal origin products applies that they may not come from protected areas.

Cultivation / primary production:

The following origins are permitted:

• EU/United Kingdom/Norway cultivated and/or caught product, excluding marine areas;
• Baltic Sea
• Black Sea
• Caspian Sea
• Cultivated and/or caught product off the west coast of South America (Chile, Peru)
• Product caught around Iceland
• Product caught off the west coast of Morocco and Mauritania

Fish are caught in open sea, thus not in river mouths, bays or other estuaries in which industrial waste water might be present.

Processing: Country of cultivation/catch or origin: Western Europe

Review of new areas of origin:

New provenance areas are only admitted after review and approval by SecureFeed. A request for admission of a new provenance area is submitted to SecureFeed and contains at least the following information:

• An unambiguous description of the growing region / catchment area (e.g. on the basis of FAO Major Fishing Areas, https://www.fao.org/fishery/en/area/search);
• A description of the species grown/caught;
• Independent data on dioxins, dioxin-like PCBs and non-dioxin-like PCBs for fish and fish (by-)products from the region concerned;
• Information on the quality assurance system of the producer of the fish and fish (by-)products (GMP+ FSA, ISO22000 etc.), if possible supplemented with relevant fishing standards (e.g. Marine Stewardship Council on sustainable fishery);
• Data on the use of processing aids and additives;
• Historical data on dioxins, dioxin-like PCBs and non-dioxin-like PCBs for fish and fish (by-)products from the producer/supplier;
• Information on analysis results / levels of PAHs and heavy metals (mercury, arsenic, lead, cadmium) in the products intended for delivery to SecureFeed participants.

SecureFeed assesses the request based on the information provided and makes a decision on whether or not to admit a new area of origin. The submitter of the request will be informed of the result of the assessment.

Producers

Suppliers are only allowed to purchase from producers and fish processors that have been assessed and approved by SecureFeed. SecureFeed sets the following requirements for producers and fish processors:

• Suppliers must have an up-to-date list of producers that are demonstrably known to SecureFeed. These producers have been assessed and approved by SecureFeed before suppliers are allowed to supply products from these producers to SecureFeed participants. Producers and fish processors are EU approved. In addition, the following applies to the different regions:
• EU / United Kingdom / Norway / Iceland: In case of processing of fish by-products, the previous links (fish processing, filleting companies, etc.) must be clear. These products must be purchased directly from the fish-processing company, on the basis of clear specifications.
• Other regions: Sealed transport from producer to tank/bulk storage.

Raw materials

Raw materials may not originate from protected populations and/or protected species. The IUCN Red List can be consulted for the current status of the fish species / fish groups.

Labelling and freight documents

Each delivery of a batch is accompanied by a copy (digital / paper) of the original analysis certificate for the named contaminants, belonging to this batch. At the time of delivery, this certificate of analysis should not be older than 3 months. The applicable GMP+ and statutory requirements should also be complied with.

Monitoring

¹The dioxin analysis can be executed on the whole fish.

Annex 4: Additional product conditions: egg products

The additional conditions for egg products apply to the following product types:

*European Feed Material Register

Propagation process

The following applies to all egg products:

1. Egg products, intended for animal feed, must be produced using a process which demonstrably meets the conditions referred to in:
• EU Regulation 142/2011 Annex IV Chapter III paragraph G: Processing method 7 OR
• Vo. 142/2011 Annex X, HII, afd. 9 B b) and approved by SecureFeed
2. In case of Processing method 7: The results of the validation of the applied process, including the results of the final product samples investigated for Clostridium perfringens during 30 consecutive production days, must be available to SecureFeed; the validation takes place before the installation is put into use and at each relevant modification of the installation.
3. The effectiveness of the applied process must be verified annually and the results must be available to SecureFeed.
4. The registration of the critical process parameters must be kept for at least 2 years and be available for SecureFeed.

Monitoring egg-products, excluding Eggshells, dried, heat treated (SPR)

¹In moist egg products, with the exception of annual verification (see header 'Propagation process'), the determinations for Salmonella, Enterobacteriaceae and Clostridium perfringens may be replaced by an instrumental pH measurement with a calibrated measuring instrument.

Positive Release

Positive Release applies to the Salmonella determination.

Monitoring Eggshells, dried, heat treated (SPR)

Annex 4 (Continued): Egg Products - Monitoring Details

where:

n = number of samples to be tested, evenly distributed throughout the batch;

m = threshold value for the number of bacteria; the result is considered satisfactory when the number of bacteria in all samples does not exceed m;

M = maximum value for the number of bacteria; the result is considered non-satisfactory when the number of bacteria in one or more samples is equal or larger than M, and

C = the number of samples for which the bacterial count may show a result between m and M, and where the samples are still considered acceptable if the result of the bacterial count for the other samples is not greater than m.

Positive release

Salmonella, Entero bacteria and Clostridium Perfringens analysis on Positive release. For Salmonella and Entero bacteria, all five analysis results must be known and meet the standard before the batch can be released.

Scaling down monitoring

If a supplier has met the monitoring requirements for one year and has compliant monitoring results, a request to scale down the monitoring frequency of Clostridium perfingens can be submitted to SecureFeed. An audit will assess whether scaling down is possible. If this is the case, a new monitoring frequency will be determined and recorded. If, after scaling down, a sample is found outside the set requirements, a return will immediately be made to the monitoring requirements as described in Monitoring.

Annex 5: Additional product conditions: animal by-products

The additional conditions for animal by-products apply to the following products:

Raw materials

Feather protein solution, hydrolyzed (SPR) and Feather protein, hydrolyzed (SPR) may only be manufactured from feathers from recognized slaughterhouses.

Monitoring

Positive Release

A Positive Release applies to the Salmonella determination.