general rules of traceability of abp · definition of traceability (art.3) and some requirements...

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GENERAL RULES OF TRACEABILITY OF ABP Victor Zamfirescu, Romania [email protected]

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GENERAL RULES OF TRACEABILITY OF ABP

Victor Zamfirescu, Romania

[email protected]

Introduction

Remember

BSE crisis in 1996 and 2000

Dioxin crisis in 1999

….

Have illustrated the particularly importance of being able to swiftly identify and isolate unsafe products

Introduction

• Regulation CE no.178/2002 (General Food Law) laid down definition of traceability (art.3) and some requirements for traceability (art.18(1))

• Traceability is a risk-management tool used by:– Operators to trace and follow the ABP/derived products and to

take appropriate measure in case of non-compliance with law.

– Competent Authorities to perform their duties as regard officialcontrol

Introduction

Main objectives of traceability in ABP sector

� To prevent contamination of food by ABP

� To prevent contamination of feed by category 1 & 2 ABP

AGENDA

• Part I - General Principles

• Part II - Obligation of operators along the chain• Part III - Official control

Starting point (R.1069/2009, art.4(1), whereas (21))• It is considered the moment when ABP are produced

and consequently ABP fall under incidence of ABP regulation

• Once a product is considered as ABP (starting point), the producer of ABP must apply ABP traceabilityrules.

Part I - General principles

Principle n° 1 :The traceability applies at the starting point

SCOPE of ABP regulation

Products of animal origin or

raw material fit for humanconsumption

ABP « By Law »

Decision by operator

Irreversible

ABP« By choice »

Traceabilityaccording ABP rules

Traceability according Food rules

Starting point

Hygiene package

End point (R.1069/2009, art.5, whereas (22))• It is considered the moment when derived products

are no longer under incidence of ABP regulation• After end point no traceability and official control are

required under Regulation no.1069/2009• End point is specified for derived products mentioned

in art.33, 35 and 36

Part I - General principles

Principle n° 2 :The traceability applies until the disposal or use of

ABP, unless it exists an end point

TR

AC

EA

BILIT

Y

Derived productsdisposed of,intended for

feeding farmedanimals and

OF/SI

STARTING POINT

Derived productsintended for

pet food, feedingfur animals and

technicalproducts other

than OF/SI

END POINTStep n

Step 0

CollectionTransport

Storage of ABP Treatment Processing

TransformationStorage of DP

DistributionPlacing on the

marketUse

Generationof ABP

ABP Traceability

rules

TR

AC

EA

BILIT

Y

Step 1

Step 2

Step 3

In the SCOPE of ABP regulation

ABPABP

Pigintestines

Mucus Heparin

Traceability according ABP rules

Traceability according CE legislation on

medicinal products

End point

An example of manufacturing chain with end point

Storage

Placing on the market

Handling / Treatment of ABP

Approval

Registration

Manufacturing of Medicinal

products

Producer of ABP(slaughterhouse)

Part I - General principles

Principle n° 3 :To ensure the separation between the 3 categories

of ABP at each stages of ABP chain

= obligation of operators (R.1069/2009, Art. 4(2))

Principle n° 4 :To ensure the correct destination of ABP

Part I - General principles

Principle n° 5 :To ensure that an adequate system is in place that

guarantees the correct destination of ABP

= obligation of Member States (R.1069/2009, Art. 4(3)(4))

• Operators have responsibility regarding collection, identification by categories, transport and traceability of ABP (R.1069/2009, Art 21(1) and (2), Art 22(1) and (2))

Part II. Obligations of operators along the chain

- separation of ABP produced by each category

Slaughterhouses

Farms FoodIndustry&

retails

Cat 1

Cat 2

Cat 3

PRODUCTI

ON OF ABP

Cat 1

Cat 1

Cat 1

Cat 2

Cat 3

DEDICATED

CONTAINERS

Part II.1. Production of ABP (Starting point)

– Identification of ABP (mandatory for SRM – Annex V, point 3 of Regulation CE no.999/2001)

– Temporary storage of ABP in dedicated containers and identification of containers for each category.

Production of ABP: Example of slaughterhouses

– Producers of ABP shall have an adequate procedure to ensure correct destination of ABP (eg: use a national list of ABP plants)

Transport of liquid ABP (blood)Collection of fallenstock in farms

Collection of ABP at slaughterhouse

Part II.2. Collection and transportation of ABP(Art.4(2), Art.21(1) and (2), Art.22(2))

� Collection of ABP without undue delay

� Registered transporters

� Identification of means of transport/containers/package

� Transport of ABP/derived products in dedicated means of transport/containers� link with Regulation CE no.999/2001 (Annex IV, part II and

III) – PAP must be transported in dedicated facilities and not together with feedingstuff for ruminants

� link with Regulation CE no. 852/2004 (Annex II, Chapter IV)

� Hygiene requirements and leak proof

� Controlled temperature for transport of category 3 material > 24hours

Part II.2. Collection and transportation of ABP

Identification of container

Category 1

Colour code : black

Specific mention : « For disposal only »

Category 2Colour code : yellowSpecific mention : « not for animal consumption »

or, when Category 2 material is intended for thefeeding of animals, « for feeding to …+ the name of the specific species of those animal(s) »

Category 3Colour code : greenSpecific mention : « not for human consumption ».

CAT. 1For disposal only

CAT. 2Not for animal consumption

CAT. 3Not for human consumption

Similar to previouslegislation

Identification of container

Specific mention for certain ABP or derived products

NEW : gathered in the same regulation (R. 142/2011, Annex VIII, Chapter II)

• C1 used for manufacturing of derived products

• milk, milk-based products, milk-derived products, colostrum and colostrum products

• gelatin, collagen

• raw pet food

• fish and derived products from fish intended for feed for fish

• blood products from equidae for purposes other than in feed

• horns, hooves and other materials for the production of organic fertilisers and soil improvers

• organic fertilisers and soil improvers

• manure and digestive tract content

• intermediate products

• material used for feeding (derogations)

• research and diagnostic samples

• trade samples

• display items

Part II.3. ABP establishments or plants(R.1069/2009, Whereas (26), Art. 22(2), 23, 24)

- Approval : Operators shall ensure that establishments or plants under their control are approved by the competent authority for a dedicated category

- Registration: Operators shall notify the competent authoritybefore commencing operations in establishments or plants under their control for a dedicated category

- At each stage of chain (from starting point to final use/disposal or end point if it exists), establishments or plants generating ABP or handling ABP/DP shall have an adequate procedure to ensure correct destination of ABP/DP (eg: use of national list of ABP plants)

Marking of MBM

- WHY?- to differentiate MBM cat 1&2 from PAP cat 3

- to trace any cross contamination of MBM cat 1&2 with PAP cat 3

- HOW ? With GTH

- WHERE ? In processing plants/establishments

Part II.4. Marking of certain products

Part II.4. Marking of certain products

Marking of organic fertilisers and soil improvers

- WHY? To prevent any cross contamination of OF-SI with feed

- WHERE ? In any plants / establishments located in OF-SI manufacturing chain

- HOW? Mixing with a sufficient minimum proportion of a component which is authorised by the competent authority of the Member State where the product is to be applied to land

- Lime, manure, urine, compost, digestion residues from biogas or mineral fertilisers

- Component determined on the basis of an assessment of the climatic and soil conditions

- List of the authorised components made available by CA to the Commission and to other MS

All operators involved in ABP chain (producers of ABP, transportersand registered/approved plants/establishments) shall:

- keep the records of consignments of ABP/derived products and related commercial documents or health certificates

- ensure that ABP/derived products are accompanied during transport by a commercial document and when is necessary by a health certificate

Part II.5. Registry, commercial documents and health certificate

(R.1069/2009, Art.21(2) and(3), Art. 22(1))

� Once end point are reached , there is no longer obligation to keep records and commercial documents/health certificates according of Regulation CE no.1069/2009

Model of commercial documents

- European model of commercial document described in R. 142/2011 (Annex VIII, Chapter III)

- For transportation within Member State : CA can adopt their own model of commercial document BUT taking into account the specification set up in R.142/2011.

Similar to previouslegislation

Part II.6. DEROGATIONSfrom applying rules of traceability

No obligation to keep registry and without commercial documents/health certificate (R. 1069/2009, Art.21(2) 2nd

paragraph, (6)(b), Art.22(1) 2nd paragraph) :

- For transport of manure within same Member State ONLY with authorization from competent authority

- For transport of certain derived product (details arementioned in R. 142/2011)

• In implementing rules are mentioned derogation from traceabilityfor “compound feed” produced from ABP/derived products, as defined in Art.3(h) of Regulation 767/2009.

• For compound feed, no need for :

- identification and labeling- commercial documents and records

DEROGATIONBorder between ABP rules and Feed rules

DEROGATION Organic fertilisers and soil improvers

No obligation of labelling for:

• OF/SI in ready-to-sell packages of not more than 50 kg in weight

• OF/SI in big bags of not more than 1000 kg in weight– If authorised by the competent authority of the Member State

based on an assessment of the possibility of diversion of material to farms or pasture which are accessed by cattle

– If it is indicated on those bags that they are not destined for application to land to which farmed animals have access.

Part III. Official controls(R. 1069/2009, Art.45, Art.47 and Art.48)

The competent authority shall at regular intervals carry out official controls and supervisions along the ABP chain as regard traceability

1. Official control of separation and identification of ABP and of means of transport

2. Official control of correct destination of ABP/derived products

3. Official control of registry/commercial documents and cross-check of commercial documents

4. Official control of dispatching ABP/derived products to other Member States

Inspection report

Non compliancesidentified

Operator

Competent authority

Official controlsAt producer level (starting point)Along the chain���� categorization, separation, identification, destination of ABP/DP���� registry / commercial documents and cross-check of documents

Corrective action plan

- Procedure to ensure correct categorization of materials

- Procedure to ensure correction separation and identification of ABP

- Procedure to ensure correct destinations

���� Training of personnel

Official control of correct destination of ABP/derived products

An essential tool for ensuring a correct destination and to perform official control is “The list of ABP approved/registered plants/establi shments”which are available on web page of each Competent Authority

Link of European Commission web page – List of approved ABP establishments

http://ec.europa.eu/food/food/biosafety/establishments/list_abp_en.htm

New technical specifications

for codification of lists

The Competent Authorities shall verify if:

- Approval by CA of destination : the application submitted by operators from Member State of origin are approved by Competent Authority from Member State of destination for intracommunity trade of C1 and C2 material and MBM and fat derived from C1 and C2 material (model in R.141/2011)

� No longer required for PAP

- Notification by TRACES system for C1 and C2 materials, MBM and fat derived from C1 and C2 material and PAP

- Transporters of ABP/derived product are registered and means of transport/containers are identified as required (color coding)

Part III.3. Official control of dispatching ABP/DP to other Member States

Reduction of administrative

burden

Thank you for your attention !