Product Board Animal Feed

1. ------IND- 2004 0042 NL- EN- ------20040217 ------PROJET

Product Board Animal Feed

DRAFT

AMENDMENT II TO THE PRODUCT BOARD ANIMAL FEED (PDV) REGULATION ON GMP CERTIFICATION IN THE ANIMAL FEED SECTOR 2003

Regulation of the Product Board Animal Feed of .. .. 2003 amending the GMP regulations for the animal feed sector (PDV regulation on GMP regulations for the animal feed sector 2003)

The Executive Board of the Product Board Animal Feed;

Having regard to Articles 93 and 95 of the Dutch Industrial Organisation Act and Articles 2, 4 and 9 of the Ordinance establishing the Arable Product Boards 1997, or the Decree establishing the Arable Product Boards once it has entered into force;

Hereby decrees:

Article I

The PDV regulation on GMP certification in the animal feed sector 2003 shall be amended as follows:

The following definition shall be inserted into Article 1:

q.waste product:a product that is on the negative list set forth in part B of appendix

GMP14 or a product for which there is no risk assessment in the Public Database of Risk Assessments for Feed Materials and which may, therefore, no longer be destined for use as animal feed.

The appendix ‘GMP standard for road transport in the animal feed sector, GMP07’ shall be amended as follows:

1.Point 4 of Appendix1 shall now read:

4.Carriers using bulk tankers must wet-clean these tankers at least once a quarter.

2.In Annex B: ‘Categorisation of substances and materials’, new products have been classified in categories 3 and 4, which are shaded in grey in Appendix1 to this regulation.

Part C5: ‘Biogenous amines’ of the appendix ‘GMP regulations on product standards in the animal feed sector, GMP14’ shall now read:

Contaminant / Product / Action threshold / Rejection threshold / Source or particular requirements
Chemical
Biogenous amines[1] / Animal feed rich in protein / 4000 mg/kg protein / > 30% crude protein

A new standardfor the production of and trade in pet food, GMP19, attached as Appendix2 to this regulation, shall be added to the regulation.

Article II

This regulation shall be published in the Dutch Trade Journal and shall enter into force on the second day following publication.

The Hague, …. 2003

Th.A.M. MEIJER

Chairman

J. DEN HARTOG

Secretary

EXPLANATORY NOTE

Amendment I to the PDV regulation on GMP regulations for the animal feed sector 2003 changed the official title of the regulation: this is reflected in the title of the presentamending regulation.

A definition of waste products has been inserted into part A. The background to this is that, when environmental permits are issued, by-products of the foodstuffs, fermentation and pharmaceuticals industries are being regarded as waste products when they could be used as feed materials in the animal feed sector. The definition of waste products in the GMP regulations states that high-quality by-products may be sold as animal feed and be covered by GMP assurance, whereas products that are on the negative list or for which there is no risk assessment in the Public Database of Risk Assessments for Feed Materials shall be regarded as waste products.

A small number of amendments have been made to the GMP standard for road transport in the animal feed sector, GMP07 (part B).

Previously, a carrier using bulk tankers had to inspect the whole interior of the bulk tank for any deposits and remove them by means of a suitable cleaning regime at least once a quarter. This obligation has been changed to wet cleaning at least once a quarter.

Furthermore, a small number of new products have been classified in categories 3 and 4. The following applies with regard to artificial fertilisers:

The specified artificial fertilisers that are transported in bulk tankers can only be classified in category 4 if a consignment of artificial fertiliser is alternated with one of animal feed. That is to say, one cargo of artificial fertiliser, followed by one cargo of animal feed, and then another cargo of artificial fertiliser. Following multiple cargoes of artificial fertiliser, it is compulsory to perform the category3 cleaning regime. The grounds for this classification are that the occasional transport of artificial fertiliser in bulk tankers does not entail any food safety risks, but, when it is transported over longer periods, it becomes encrusted and can then potentially cause problems.

After transporting the specified category 4 artificial fertilisers in bin wagons, cleaning regimeA: dry cleaning must be performed. The grounds for this classification are that dry cleaning bin wagons can be performed effectively, thus minimising the food safety risks.

The artificial fertilisers that conditionally fall within category 4 account for approximately 80-90% of the total quantity of artificial fertilisers to be transported. If companies want to have other or new artificial fertilisers classified in category 4, the procedure for the (re)classification of products in transport categories can be followed (Annex C to GMP07).

Part C amends the product standards for biogenous amines. It has been found that biogenous amines do not give rise to health problems in either ruminants or non-ruminants in the quantities found in animal feed. Consequently, it is not necessary to lay down standards with regard to biogenous amines in animal feed on these grounds. Biogenous amines that are the result of natural protein degeneration in animal feed rich in protein (> 30% crude protein), however, can be an indicator of the degree of decay in this feed. The content must not exceed 4000 mg/kg protein. It is not considered necessary to set an action threshold, as sufficient attention is already paid to this within the framework of the risk assessment of each product and production process.

A new standardfor the production of and trade in pet food, GMP19, has been added to part D. Previously, GMP-certified companies producing pet food fell within the GMP standard for trade in and production of compound feed. It had been difficult for these companies to comply with all the obligations deriving from that standard, however. For that reason, a separate GMP standard has been drawn up, in cooperation with the Pet Food Sector Committee.

This regulation has been notified in draft form to the Commission of the European Communities pursuant to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services (OJECL204), as amended by Directive 98/48/EC of 20July 1998 (OJECL217).

The Hague, …. 2003

Th.A.M. MEIJER

Chairman

J. DEN HARTOG

Secretary

/ Appendix 1
Product Board Animal Feed

GMP standard for road transport in the animal feed sector

GMP07; 12-11-2003

© Productschap Diervoeder (Den Haag, Nederland) – April 2003

All rights reserved. Nothing in this publication may be reproduced, stored in a database or published in any form whatsoever, whether electronic, mechanical, by photocopying or photography or by any other means, without the prior written permission of the owner/publisher.

GMP standard for road transport in the animal feed sector 1 of81

GMP07;12-2-200312-11-2003 ©PDV

CONTENTS

1SUBJECT AND SCOPE

2REFERENCES TO STANDARDS

3TERMS, DEFINITIONS, TARGET GROUPS

4QUALITY SYSTEM REQUIREMENTS

4.1Management responsibility

4.2Quality system

4.3Standards

4.3.1Assumptions

4.3.2General

4.3.3Preventing the risk of carry-over of additives and veterinary medicines

4.3.4Undesirable substances and products

4.3.5Hygienic operation

4.4Design control

4.5Document and data management

4.6Purchasing

4.7Control of products supplied by the customer

4.8Identification and traceability of products

4.9Process control......

4.9.1General

4.9.2Undesirable substances and products

4.9.3Hygienic operation

4.9.4Transport sequence, collective loading, cleaning and disinfecting

4.10Inspection and testing

4.11Control of inspection, measuring and test equipment

4.12Inspection and test status

4.13Control of nonconforming products

4.14Corrective and preventive action

4.15Handling, storage, packing, preservation and delivery

4.16Control of quality records

4.17Internal quality audits

4.18Training

4.19Aftercare

4.20Statistical techniques

APPENDIX I: CLEANING, DISINFECTING AND LOADING SEQUENCE FOR TRANSPORT OF ANIMAL FEED

Annex A: Rules for transport sequence, collective loading, cleaning and disinfecting

Annex B: Categorisation of substances and materials

Annex C: Procedure for the (re)classification of products in transport categories

Annex D: Residue sampling and determination in cargo spaces following transport of products for which a (re)classification in cargo categories has been requested (road transport)

Annex E: Procedure for acceptance of cargo spaces following transport of prohibited cargoes

Annex F: Protocols relating to the transport of stackable poultry and horse manure

GMP standard for road transport in the animal feed sector 1 of81

GMP07;12-2-200312-11-2003 ©PDV

1SUBJECT AND SCOPE

This GMP standard is a supplement to the general GMP standard for the animal feed sector (GMP01), which is intended for companies (suppliers or customers) that carry out or award contracts for the road transport of feed materials, premixes, animal feeds or additives.

The general GMP standard for the animal feed sector (GMP01) remains fully in effect, where applicable.

Where a recipient of feed materials purchases these products from a non-GMP-certified supplier who orders the transport, the recipient must demonstrably agree with the supplier that the transport of feed materials shall take place according to the stipulations of this supplementary standard.

Where a company carries out other activities covered by a supplementary GMP standard (for example, for transport of or trade in feed materials), the company must explicitly obtain GMP certification for those activities.

On account of the differences in structure and nature of the different forms of transport, the following distinction has been made:

Road transport (GMP07)
Sea shipping, inland shipping and rail transport (GMP08)

2REFERENCES TO STANDARDS

3TERMS, DEFINITIONS, TARGET GROUPS

4QUALITY SYSTEM REQUIREMENTS

4.1Management responsibility

4.2Quality system

4.3Standards

4.3.1Assumptions

In this standard, the responsibility of the carrier is limited to the service of transporting feed materials, compound feed and premixes. This service may be carried out by an external (transport) company but also by a GMP-certified animal feed supplier using its own transport.

If the transport is undertaken by a GMP-certified company using its own transport, the GMP certification for the company in question must also relate to transport, whereby it must be possible to demonstrate compliance with the conditions pursuant to the GMP regulations.

Where transport is provided by an external (transport) company, this company must be able to demonstrate that it complies with the conditions pursuant to these GMP regulations. It is required that this company hold an approval certificate from an independent body accepted by the Product Board.

External companies involved solely with packaged goods are exempted from the (certification) condition(s) pursuant to the GMP regulations.

GMP standard for road transport in the animal feed sector 1 of81

The acceptance policy of a carrier certified in the way specified above has no correlation with the quality or condition of these products in relation to the legal requirements for these products.

4.3.2General

Transport companies must make it clear to customers purchasing their bulk transport services that they operate in accordance with rules guaranteeing that the services supplied comply with the GMP requirements and legislation on feed materials, compound feed and premixes in relation to human, animal and environmental safety (basic quality), and any specific requirements that the customer may make of the service.

As regards the performance of transport activities, the GMP manual shall at least contain a procedure for acceptance of an order for the transport of feed materials, compound feed and premixes.

A company carrying out bulk transport of feed materials, premixes and compound feed must establish the relevant characteristics of these products with regard to the need to keep the products separate and the cleaning and disinfecting procedures required between successive cargoes[2]. Criteria have been established for application of the correct procedures for the separation of products, cleaning and disinfecting, and also tolerances for nonconformance. Relevant characteristics in this context may include moisture content, temperature, odour, colour and the presence of vermin.

In the case of transport of packaged products, it is sufficient that the cargo compartment is clean, which means emptied completely and free of residue and odours from previous cargoes, and that it is dry or dried.

4.3.3Preventing the risk of carry-over of additives and veterinary medicines

A system for recording the transport sequence and cleaning between successive bulk consignments shall be in place. The aim is to guarantee that previously transported compound feed, premixes and feed materials do not exceed the maximum cross-contamination levels for additives and veterinary medicines in successively transported consignments of compound feed, premixes and feed materials.

4.3.4Undesirable substances and products

The aim is to use a system that demonstrates that the basic quality of feed materials, compound feed and premixes handed over for transport is not compromised by any undesirable substances or products as a result of transportation.

4.3.5Hygienic operation

The aim is to use a system of hygiene that demonstrates that the quality of the transport service is controlled. The quality of the service must be controlled at critical points in accordance with the standards and requirements laid down by the company.

4.4Design control

4.5Document and data management

4.6Purchasing

4.7Control of products supplied by the customer

4.8Identification and traceability of products

When awarded a transport contract, the company must obtain information from its client regarding product categories, including GMP transport codes as laid down in the appendix to this standard. This relates to both the standard for classification in the ‘following cargo’ category and the one for classification in the ‘previous cargo’ category.

The carrier shall have a reliable administrative system in which at least the following are included:

the quantities and types of product[3] by client (i.e. the customer purchasing the transport service);
where applicable, copies of any accompanying documents, guarantees, certificates, etc.;
the loading and unloading addresses;
the identifiers and codes for the bulk cargo compartments that enable the continued operation of the transport sequence for bulk goods.

The above data on clients and loading and unloading addresses may be documented in coded form, provided that external auditors are provided with information elsewhere in the records on the data underlying the standards used.

4.9Process control

4.9.1General

Feed materials, compound feed or premixes (for combined transport) must not become mixed with each other if this would compromise the basic quality[4]. If this does occur, however, it must be established what action is to be taken with regard to the feed material, premix or compound feed and to the parties concerned. Nonconformance and the resulting corrective action must be documented.

Bulk cargo compartments shall be suitably identified, and the transport sequence of the products in the cargo compartments concerned shall be traceable, for instance by coding the compartments and by means of journey logs, whether or not in electronic form, that are kept on board the vehicle.

For bulk transport, preceding cargoes must be recorded by the driver for each cargo compartment in a journey log, whether or not in electronic form, kept on board the vehicle, and a cleaning procedure must be laid down that demonstrably complies with legal requirements and supplementary standards[5] for cleaning (and disinfecting) vehicles that are contained in the GMP regulations.

The general rule is that the cargo space must be clean, which means emptied completely, free of residues and odours from preceding cargoes, and dry or dried where subsequent cargoes are dry. The driver must visually check this before each transport of (animal) feed (materials).

The cleaning and disinfecting operations for each bulk cargo compartment must be noted and initialled by the driver in the journey log, whether or not in electronic form. The result of the cleaning and disinfecting operations must be checked visually and recorded in the journey log along with the preceding cargoes and the cleaning and disinfecting operations.

The data in the journey logs are subsequently to be transferred to the logbook at the offices of the transport company. This can be done by simple compilation of the journey logs and must be carried out at least once a month.

The logbook (with the journey logs) must be retained for at least three years. The information required as part of the Regulations on the prohibition of animal meal in animal feed (1999) must be retained for seven years.

4.9.2Undesirable substances and products

Feed materials, premix and compound feed are to be transported in such a way that they do not become contaminated with undesirable substances and products. This must be ensured particularly where products other than feed materials, compound feed or premixes (or feed materials, compound feed or premixes the basic quality of which is compromised by undesirable substances to an extent relevant to transportation) are to be transported in the same cargo space 2. In so far as this is dependent on the transport, there must be a procedure laying down how this is to be realised, controlled and guaranteed.

4.9.3Hygienic operation

Products are to be transported in such a way as to control basic quality in hygiene. This must be ensured particularly where types of goods other than feed materials, compound feed or premixes (or feed materials, compound feed or premixes the microbiological basic quality of which is compromised to an extent relevant to transportation) are transported in the same cargo space2. There must be a procedure laying down how this is to be controlled.

For dry feed materials, compound feed and premixes, the ingress of rainwater and splash water must be prevented during transport. A procedure must be drawn up to deal with this eventuality. Action taken and the result must be recorded. For the transport of dry feed materials, compound feed and premixes in bulk, cargo compartments – even if they are empty – are to be covered in order to prevent the ingress of rainwater and contamination with bird droppings. If it is not possible to cover empty cargo spaces, these must be wiped dry, after hosing clean, if necessary, before another cargo is loaded. Tarpaulins for covering cargo compartments must be clean before a bulk cargo is loaded and, when dry feed materials, compound feed or premixes are loaded, they must also be dry.

Furthermore, the outside of the vehicle, including the chassis, must be free of visible traces of the previous cargo prior to the transport of feed materials, compound feed and premixes.