FEMAS Vegetable Fats & Oils Sector Notes November 2015

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2 AGRICULTURAL INDUSTRIES CONFEDERATION LIMITED (AIC) 2015 All rights reserved. No part of this publication may be reproduced or transmitted in any material form or by any means, mechanical, electronic, photocopying, recording or otherwise, or stored in any retrieval system of any nature, without the prior written permission of the copyright owner except in accordance with the provisions of the Copyright, Designs and Patents Act WARNING: The doing of an unauthorised act in relation to copyright may result in both a civil claim and a criminal prosecution. AIC and its officers, employees, agents and subcontractors accept no liability whether in contract, tort (including negligence), breach of statutory duty or otherwise for any loss (including indirect or consequential losses) by a participant or other third party arising under or in connection with the scheme and its administration save only to the extent that statute prohibits exclusion. NOTE: Although these Sector Notes may be translated into various languages for the convenience of users, the English version remains the definitive reference document in the event of any dispute.

3 NOTES ON THE IMPLEMENTATION OF FEMAS FOR BUSINESSES PROCESSING & BLENDING VEGETABLE FATS & OILS Sector Notes are provided to assist FEMAS participants and assessors in establishing some background knowledge of specific feed industry supply sectors where issues may exist that are uncommon, or of less relevance, in other sectors. These Notes are not necessarily exhaustive. These Sector Notes are relevant to businesses involved in the processing and blending of vegetable fats and oils for use in animal feed. With reference to Commission Regulation (EU) No 68/2013 of 16 January 2013 Catalogue of Feed Materials, these Sector Notes cover feed materials in the category: Oil Seeds, Oil Fruits, and Products Derived Thereof and Miscellaneous. These Notes are laid out in the same format as the FEMAS International Core Standard. Where additional comment is necessary, the clause reference is to the appropriate section of the FEMAS International Core Standard. It is emphasised that the comments included in this document are intended to assist in the application of the corresponding requirements of the FEMAS International Core Standard and are not to be considered in isolation. For clauses where no additional comments are provided in this document, the original requirements of the FEMAS International Core Standard continue to apply without any additions or exclusions. In subsequent issues, additions and amendments to these Notes will be shown in blue italics, for ease of reference. The assistance of the Feed Fat Association (ffa) is gratefully acknowledged in preparing these Notes. For further information on ffa, please contact: The Feed Fat Association C/o Dr David Howells

4 1.10 Definitions Batch: An identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packaging, packer, consignor or labelling, and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units, when produced in continuous order and stored together. (Regulation (EC) No. 767/2009). Products derived from oils and fats: 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: the refined oil, products derived from refined oil, and feed additives; (Regulation (EU) 2015/ 1905) Fat Blending: The manufacturing of compound feed or, in case of all components belonging to the same entry in PART C of the Annex to Commission Regulation (EU) No 68/2013 (*) which are derived from the same plant or animal species, of feed materials by mixing crude oils, refined oils, animal fats, oils recovered from food business operators falling within the scope of Regulation (EC) No 852/2004 or products derived thereof to produce a blended oil or fat, with the exception of the: sole storage of consecutive batches, and exclusive mixing of refined oils; (Regulation (EU) 2015/ 1905) Refined oil or fat: Oil or fat that has undergone the process of refining as referred to in No 53 of the glossary of processes listed in Part B of the Annex to Regulation (EU) No 68/2013. (Regulation (EU) 2015/ 1905) For additional definitions refer to the FEMAS International Core Standard.

5 Permitted Vegetable Fats & Oils For the purposes of these Sector Notes, the vegetable fats & oils permitted to be included in feed ingredients supplied under the FEMAS programme are restricted to those listed in the Community Catalogue of Feed Materials established under Regulation (EC) No 767/2009. Participants should refer to Commission Regulation (EU) No 575/2011 and any Amendments. Applicable Specifications Where the following fats & oils are used, the indicated specifications apply: Acid Oils Volatile Matter: Maximum 2% Insoluble Impurities: Maximum 0.4% FFA: <70% Fatty Acid Profile: Reflects parent oil e.g. Soya Acid Oil will have fatty acid profile of Soybean Oil. Food Factory Vegetable Oil: Vegetable oil directly derived from factories processing food products. Fatty acid profile must match constituent oils. Free Fatty Acid maximum 5%. Mixed Unused Vegetable Oils / De- Packaged Oils: Produced from unused vegetable oils, margarines, shortenings and spreads which are returned in original packaging to the producer, or a processor, or have never left the producers site as they are deemed unacceptable due to reasons such as: shelf life, unacceptable colour or smell, failed QC etc. These may also include material held in bulk storage tanks on the producer s site. Fatty acid profile must match constituent oils Vegetable Fats & Oils Prohibited by FEMAS The following vegetable fats & oils must not to be used in FEMAS- certified feed ingredients: Tank Bottoms Effluent Processing Material Used Cooking Oil (UCO) High Erucic Rapeseed Oil Tanker Washings Cashew Shell Oil Castor Oil Oil Recovered from Mineral Filters Distillation Residues

6 SECTION 2 QUALITY MANAGEMENT SYSTEM 2.1 General Requirements FEMAS participants must be approved in accordance with Annex II of Regulation (EC) No 183/2005 (the Feed Hygiene Regulations ) unless they are registered for processing crude vegetable oils under Regulation (EC) No 852/2004 (the Food Hygiene Regulations ). Those operating under the Food Hygiene Regulation will still need to register as a feed business under the Feed Hygiene Regulations. SECTION 3 RESOURCES AND GOOD HYGIENIC PRACTICES 3.3 Production / Processing Facilities & Equipment During production, participants must either keep all products intended for inclusion in animal feed physically separated from all other products, unless the latter comply with both Regulation (EC) No 852/2004 (the Food Hygiene Regulations ) and Annex I of Directive 2002/32/EC (Undesirable Substances in Animal Feed), or there must be a full risk assessment and appropriate cleaning must be carried out to remove any trace of such other products prior to producing products destined for feed use. Note also 3.8 (below). Cleaning methods must be validated and documented as effective and safe. Records must be maintained for all cleaning undertaken. Where participants use open settling tanks or open tanks, these must be protected against ingress by contaminants or pests. 3.4 Storage Facilities During storage, participants must either keep all products intended for inclusion in animal feed physically separated from all other products, unless the latter comply with both Regulation (EC) No 852/2004 (the Food Hygiene Regulations ) and Annex I of Directive 2002/32/EC (Undesirable Substances in Animal Feed), or there must be a full risk assessment and appropriate cleaning must be carried out to remove any trace of such other products prior to storing products destined for feed use. Note also 3.8 (below). Cleaning methods must be validated and documented as effective and safe. Records must be maintained for all cleaning undertaken. To prevent nesting and other pest access, breather pipes on bulk tanks must be suitably protected. Breather pipes must also be downward facing to prevent ingress from rainwater and other potential contaminants.

7 3.8 Cross- Contamination Where animal fats or oils are stored on the same site as vegetable fats or oils intended for feed use, participants must demonstrate effective clean- down and flushing procedures that prevent cross- contamination of vegetable fats and oils or vegetable fat blends. Cleaning methods must be validated and documented as effective and safe. Records must be kept of all clean- downs and flushing undertaken. Equipment (including flexible hoses) used for handling animal fats and oils on the same site as vegetable fats & oils must also be appropriately controlled to avoid any chance of cross- contamination Pest Control To prevent rodent access, all detachable hoses must be capped when not in use.

8 SECTION 4 TRANSPORT REQUIREMENTS Previous Loads During transport, participants must either keep all products intended for inclusion in animal feed physically separated from all other products, unless the latter comply with both Regulation (EC) No 852/2004 (the Food Hygiene Regulations ) and Annex I of Directive 2002/32/EC (Undesirable Substances in Animal Feed), or there must be a full risk assessment and appropriate cleaning must be carried out to remove any trace of such other products prior to carrying products destined for feed use. Note also 3.8 (above). Cleaning methods must be validated and documented as effective and safe. Records must be maintained for all cleaning undertaken Inspections of Land Transport Prior to Loading Where the health and safety of quality personnel would be put at risk by climbing onto road tankers to carry out internal inspections, participants must comply with one of the following: Allow safe access by provision of safety platforms from which inspections may be done Nominate and train drivers to undertake inspections (in which case records of training must be held) Utilise risk assessment methodology to put in place alternative controls that will ensure issues of cross- contamination can be avoided (e.g. by use of dedicated tankers). In any such assessment, consideration must be given to the potential effects of inadvertently mixing different grades of the same product.

9 SECTION 5 PRODUCT SAFETY MANAGEMENT Hazard Analysis / Identification (CODEX Principle 1) In evaluating the hazard of dioxin associated with vegetable fats & oils, participants must refer to Appendices I and 2 of these Sector Notes. 5.2 Raw Materials Food Factory Vegetable Oil 1. Direct Sourcing of Food Factory Vegetable Oil Food Factory Vegetable Oil that has been in contact with meat products must be segregated from, and treated as a separate raw material to, Food Factory Vegetable Oil that has been in contact only with vegetables. For the purposes of these Sector Notes the two will be distinguished as Meat Food Factory Vegetable Oil (M)FFV and Vegetable Food Factory Vegetable Oil (V)FFV. Food Factory Vegetable Oil of either type may only be used as a raw material when an authorised signatory at the source food factory has confirmed in writing their understanding that the surplus oil supplied will re- enter the human food chain. Food Factory Vegetable Oil in Contact with Meat - (M)FFV Vegetable Oil used for cooking or flash frying meat, poultry or fish products may only be sourced from identified food factories. Participants handling (M)FFV must meet the requirements set out by the Animal Health and Veterinary Laboratories Agency, in their advice on Use of Oils and Fats in Farm Animal Feed 1 and be approved under the Animal By- Products Regulations by the Competent Authorities. General Requirements for Food Factory Vegetable Oil Participants risk assessments of food factories must consider other possible sources of contamination such as: i) Contamination with cleaning materials and chemicals. ii) Contamination with personal protective clothing such as gloves, headwear, etc. iii) Contamination with factory canteen catering waste. iv) Incorporation of material recovered from fat traps. v) Contamination with mineral oils and other hazardous materials in use on the site. The FEMAS Certification Body reserves the right to include visits to food factory sources as part of the audit process: 1 Viewable on The Web at:

10 1. Where bulk raw materials are received direct from food factories, up to two food factory sources of the assessor s choice will be visited as part of the audit of each processing/blending plant, at each audit. 2. Where only food- grade fats and oils contained within intact original packaging are received direct from food sources, visits to the food factory sources will only be required if specific potential hazards are identified during the audit of the processor/blender. Food factories certified to the BRC Global Standards Version 7 Voluntary Module 9 Management of Food Materials for Animal Feed will only be selected for visits where evidence is seen of significant non- compliance or other exceptional circumstances. 2. Sourcing of Food Factory Vegetable Oils via Third Parties Where raw materials from food factories are sourced via a third- party, FEMAS audits will include visits to those third- parties and their food factory suppliers as part of the assessment of the participant, unless the third party is certified to FEMAS in their own right. NOTE: Participants and assessors are advised that additional audit time will be required to accommodate visits where food factory sources are involved. 5.2 Raw Materials iii) Participants must ensure that their risk assessments of individual vegetable fats/oils include consideration of contamination with undesirable substances such as Pesticides, Dioxins & Dioxin- like PCBs. Controls must be implemented to ensure legal limits prescribed under EU feed law are not exceeded Feed Ingredient Delivery Documents & Labels Any deliveries of crude coconut oils and products derived from vegetable oils (other than glycerol, lecithin and gums) intended for feed use shall be accompanied by a proof that these products or all components thereof have been analysed or are in compliance with the requirements of below. To this end, participants must ensure the following statement is true and is included on delivery notes provided to customers: The batch, or all batches of the components thereof, from which this delivery is drawn have been tested (as required) and are all in compliance with Commission Regulation (EU) 225/ Identification of Products Not Intended For Feed Use The labelling of all products shall clearly indicate whether they are intended for feed or other purposes. If at any part of the process a participant declares that a product is not intended for feed or food use, this declaration must not be subsequently altered at a later stage of the process.

11 Analysis a) Dioxins and Dioxin- like PCBs In establishing testing frequencies for dioxins, participants must refer to Appendices 1 and 2 of these Sector Notes, which detail mandatory testing frequencies for dioxin. Analysis of dioxins and dioxin- like PCBs must be undertaken by laboratories which meet the requirements of the FEMAS Core Standard and utilise analytical methods in accordance with Commission Regulation (EC) 152/2009 (as amended by Commission Regulation (EC) 278/2012), which prescribes the methods to test for dioxins and dioxin- like PCBs. Annex 2 of Regulation (EC) 183/2005, as amended by Regulation (EC) 225/2012 and Regulation (EC) 2015/1905 requires the following analysis to be carried out as a minimum: (a) Processors of crude vegetable oils: (i) 100% of the batches of products derived from vegetable oils (other than glycerol, lecithin, gums acid oils from chemical refining, soap stocks, used filter aids, used bleaching earth) intended for feed. Batch size maximum 1,000t but see note below. (b) Fat blending establishments: Either: (i) 100% of incoming batches of crude coconut oils, oils and fats recovered from food business operators falling within the scope of Regulation (EC) No 852/2004, blended fats and oils and products derived from vegetable oils (except glycerol, lecithin, gums acid oils from chemical refining, crude fatty acids from splitting, pure distilled fatty acids from splitting and soap stocks). Batch size maximum 1,000t but see note below; Or: (ii) 100% of the batches of blended fats produced. Batch size maximum 1,000t but see note below. NOTE 1: Where it can be demonstrated that a homogeneous consignment is bigger than the batch size indicated above and that it has been sampled in a representative way, the results of the analysis of the appropriately drawn and sealed sample will be considered acceptable. NOTE 2: Where a participant proves that a batch of a product, or all components of a batch, entering his operation has already been analysed at an earlier stage of production, processing or distribution and is in compliance with the requirements of above, the participant is released from the obligation to analyse this batch and shall analyse it according to general HACCP principles. NOTE 3: Where all incoming batches of products mentioned in a) above entering a production process have been analysed in line with the requirements of Regulation (EC) No 183/2005 and its Amendments, and if it can be assured that the production process, handling and storage does not increase the dioxin contamination, the participant shall be released from the obligation to analyse the final product and shall analyse it according to general HACCP principles.

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13 b) Other test requirements The following test data must be available for all vegetable oils prior to blending or sale: i) Free Fatty Acid (FFA) ii) Moisture & Impurities (M&I) iii) Monomeric Fatty Acids (Elutables) iv) Fatty Acid Profile v) Pesticides Where Crude Vegetable Oils are received or delivered by ship, tests must be available for each vessel. Where material is received from a number of ship s tanks into a number of land tanks, each land tank must be tested. Where Crude Vegetable Oils are received or delivered by road direct from an oilseed crushing plant, tests must be undertaken on composite samples of each road tanker unless the crushing plant is certified as assured under a feed safety programme acceptable to FEMAS and records are available to confirm the suitability of the road tanker prior to loading. Additional Controls for Acid Oils and Former Food Oils All deliveries of the following vegetable oils must be tested prior to blending or sale, regardless of their source or origin: i) Acid Oils ii) Mixed Unused Vegetable Oils iii) Food Factory Vegetable Oils iv) De- Packaged Oils Test results for pesticides must be available for all deliveries prior to blending or delivery direct to customer as an Acid Oil or Former Food Oil. If the producer is certified to FEMAS in its own right with the above products identified in their scope, Certificates of Analysis may be accepted if supplied at the point of delivery. Test Data Where reliable and traceable test data can be obtained from suppliers to confirm the analysis of parcels of fats & oils purchased by the participant (e.g. for a load delivered from a bulk land tank or ship tank that has been analysed), there may be no need to undertake further tests as long as: a.) Copies of the relevant test data are held on file by the participant; b.) The analysis provided can be related to the goods delivered; c.) The laboratory undertaking the analysis meets the requirements of the FEMAS Core Standard and any regulatory obligations; d.) It can be demonstrated that comprehensive controls are in place to ensure any risk of contamination is avoided subsequent to point of testing.

14 Testing Laboratories Where a participant mandates a laboratory to perform an analysis for dioxins and dioxin- like PCBs, in accordance with a) above, they must instruct the laboratory to communicate the results of that analysis to the competent authority where the dioxin and/ or the sum of dioxin and dioxin- like PCB limits set in Annex I to Directive 2002/32/EC (as amended) are exceeded. Where a feed business operator mandates a laboratory which is located in an EU Member State other than the feed business operator ordering the analysis he shall instruct the laboratory to report to its competent authority, which shall inform the competent authority of the Member State where the feed business operator is located. Feed business operators shall inform the competent authority of the Member State where they are located if they mandate a laboratory located in a third country. Evidence must be provided that the laboratory performs the analysis in accordance with Regulation (EC) 152/2009.

15 Applicable Regulations N.B. This section of the Sector Notes is intended to assist participants and assessors in identifying specific regulations that should be considered with regard to this sector. It is not necessarily exhaustive nor does it reduce the obligation of both participants and assessors to ensure they are familiar with any regulations relevant to this sector. In addition to those regulations that apply to all feed ingredients, suppliers of Vegetable Fats & Oils based in, or supplying to, the EU must be aware of the following specific regulations: 1. Regulation (EC) No 1069/2009 Laying down health rules concerning animal by- products and derived products not intended for human consumption 2. APHA Notes re Use of Oils and Fats in Farm Animal Feeds 3. Commission Regulation (EU)No 68/2013 on the Catalogue of Feed Materials 4. Directive 2002/32 (EC) on Undesirable Substances in Animal Feed (as amended). 5. Commission Regulation (EU) No. 225/2012 amending Annex II to Regulation (EC) No 183/2005 of the European Parliament and of the Council as regards the approval of establishments placing on the market, for feed use, products derived from vegetable oils and blended fats and as regards the specific requirements for production, storage, transport and dioxin testing of oils, fats and products derived thereof. 6. Commission Regulation (EU) 2015/1905 amending Annex II to Regulation (EC) No 183/2005 of the European Parliament and of the Council as regards the dioxin testing of oils, fats and products derived thereof

16 Appendix 1. Mandatory Testing Frequencies for Dioxin The minimum testing frequency shown below reflects Regulation (EC) No 225/2012 and Regulation (EU) 2015/1905 Where the Draft Commission Regulation refers to the need for HACCP principles to be applied, the testing adopted by participants must default to a minimum testing frequency of once every 3 months. Participants must demonstrate that this level of testing is adequate based on their own test results and risk assessments. The frequency scores for specific fats & oils shown in Appendix 2 are mandatory for participants and correlate to the table below. Category Not allowed for feed. Products which require further processing before use in the food/feed chain* Product for use in feed Product for use in feed Monitoring frequency N/A Dioxin possible: Dioxin possible: Dioxin highly unlikely: 100% monitoring 100% monitoring, Test once every three months

17 Appendix 2. Mandatory Testing Frequencies for Specific Vegetable Fats & Oils 1 Fats & Oils Derived from Oilseed Crushing and Refining of Vegetable Oils Processes and products a Description Pressing and extraction Crude oil/fat Oils and fats from pressing/extraction Degumming (partially) degummed oil/fat Oil treated to remove gums/lecithin Lecithin Storage Tank bottom Physical refining Refined oil/fat and other edible products Fatty acid distillates b Chemical refining Refined oil/fat and other edible products Soap stock and fatty acids (i.e. acid oils) Distillates Viscous, solid remains on the bottom of a tank Oils/fats treated to remove colour, odour and off taste Distillate from deodorization of physical refining Oils/fats treated to remove colour, odour and off taste Caustic soda refining and soap stock splitting Distillate from deodorization after chemical refining Palm Palm kernel Rape seed Soya bean Sunflower seed Coconut Groundnut Linseed Maize Shea kernel Safflower Sesame Walnut Cottonseed Castor bean Other oil a b Where products are mixed (for instance fatty acids from physical and chemical refining), the monitoring regime of the fraction with the highest monitoring frequency applies For refineries equipped with a validated process step to remove dioxin, the fatty acid distillates shall be monitored according to the frequency regime for category 3.

18 FEMAS Vegetable Fats & Oils Sector Notes October Fats & Oils Derived from Oleochemcial Processing & Bio- diesel Production Fats of vegetable origin used as raw material for oleochemical or biodiesel production Processes and product Oleochemical production Used Cooking Oil Palm oil Rapeseed oil Soya bean oil Other oils and fats By products Biodiesel production Fatty acids with methyl esters (fatty matter) a a Fatty acids with methyl esters (also called fatty matter) collected after methanol recovery at biodiesel production are prohibited for feed purposes since lipophilic additives used in biodiesel production concentrate in the fatty acids. GN 18 Page 18 of 19

19 FEMAS Vegetable Fats & Oils Sector Notes October Fat blending Processes and product Intake Incoming batches of crude coconut oil, oils and fats recovered from food business operators falling within the scope of Regulation (EC) No 852/2004, blended fats and oils Mixing of lots Mixing of lots where all have dioxin analysis (where required) and 100% separation between feed/food and non- food products is in place. 2 4 Mixing of fats where the results for at least one of the batches requiring dioxin testing are unavailable 2 GN 18 Page 19 of 19