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REQUIREMENTS FOR FEED BUSINESSES OTHER THAN AT THE LEVEL OF PRIMARY PRODUCTION OF FEED REFERRED TO IN ARTICLE 5(1) DEFINITIONS For the purposes of this Annex, the following definitions shall apply:

(a) ‘batch’ means 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;

(b) ‘products derived from oils and fats’ means 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;

(c) ‘fat blending’ means 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;

(d) ‘refined oil or fat’ means 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. FACILITIES AND EQUIPMENT 1. Feed processing and storage facilities, equipment, containers, crates, vehicles and their immediate surroundings shall be kept clean, and effective pest control programmes shall be implemented.

2. The lay-out, design, construction and size of the facilities and equipment shall:

(a) permit adequate cleaning and/or disinfection;

(b) be such as to minimise the risk of error and to avoid contamination, cross-contamination and any adverse effects generally on the safety and quality of the products. Machinery coming into contact with feed shall be dried following any wet cleaning process.

3. Facilities and equipment to be used for mixing and/or manufacturing operations shall undergo appropriate and regular checks, in accordance with written procedures pre-established by the manufacturer for the products.

(a) All scales and metering devices used in the manufacture of feeds shall be appropriate for the range of weights or volumes to be measured and shall be tested for accuracy regularly.

(b) All mixers used in the manufacture of feeds shall be appropriate for the range of weights or volumes being mixed, and shall be capable of manufacturing suitable homogeneous mixtures and homogeneous dilutions. Operators shall demonstrate the effectiveness of mixers with regard to homogeneity.

4. Facilities must have adequate natural and/or artificial lighting.

5. Drainage facilities must be adequate for the purpose intended; they must be designed and constructed to avoid the risk of contamination of feedingstuffs.

6. Water used in feed manufacture shall be of suitable quality for animals; the conduits for water shall be of an inert nature.

7. Sewage, waste and rainwater shall be disposed of in a manner which ensures that equipment and the safety and quality of feed is not affected. Spoilage and dust shall be controlled to prevent pest invasion.

8. Windows and other openings must, where necessary, be proofed against pests. Doors must be close-fitting and proofed against pests when closed.

9. Where necessary, ceilings and overhead fixtures must be designed, constructed and finished to prevent the accumulation of dirt and to reduce condensation, the growth of undesirable moulds and the shedding of particles that can affect the safety and quality of feed.

10. Establishments carrying out one or more of the following activities to place on the market products for use in feed shall be subject to approval in accordance with Article 10(3):

(a) processing of crude vegetable oil except those under the scope of Regulation (EC) No 852/2004;

(b) oleochemical manufacturing of fatty acids;

(c) manufacturing of biodiesel;

(d) fat blending. PERSONNEL

1. A qualified person responsible for production must be designated.

2. Feed business operators must ensure that the different stages of production are carried out according to pre-established written procedures and instructions aimed at defining, checking and mastering the critical points in the manufacturing process.

3. Technical or organisational measures must be taken to avoid or minimise, as necessary, any cross-contamination and errors. There must be sufficient and appropriate means of carrying out checks in the course of manufacture.

4. The presence of prohibited feed undesirable substances and other contaminants in relation to human or animal health shall be monitored, and appropriate control strategies to minimise the risk shall be put in place.

5. Waste and materials not suitable as feed should be isolated and identified. Any such materials containing hazardous levels of veterinary drugs, contaminants or other hazards shall be disposed of in an appropriate way and not used as feed.

6. Feed business operators shall take adequate measures to ensure effective tracing of the products.

7. Fat blending establishments placing products intended for feed on the market shall keep all products intended for feed physically separated from products intended for other purposes unless the latter products comply:

— with the requirements of this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and — with Annex I to Directive 2002/32/EC of the European Parliament and the Council ().

8. The labelling of the products shall clearly indicate whether they are intended for feed or other purposes. If a certain batch of a product is declared not intended for feed use, this declaration shall not be subsequently altered by an operator at a later stage of the chain.

9. The labelling of feed materials according to Article 16 of Regulation (EC) No 767/2009 of the European Parliament and of the Council () should use, where available, the denominations as laid in Regulation (EU) No 68/2013. QUALITY CONTROL 1. Where appropriate, a qualified person responsible for quality control must be designated.

2. Feed businesses must, as part of a quality control system, have access to a laboratory with adequate staff and equipment.

3. A quality control plan must be drawn up in writing and implemented, to include, in particular, checks on the critical points in the manufacturing process, sampling procedures and frequencies, methods of analysis and their frequency, compliance with the specifications – and the destination in the event of non-compliance – from processed materials to final products.

4. Documentation relating to the raw materials used in final products must be kept by the manufacturer in order to ensure traceability. Such documentation must be available to the competent authorities for a period appropriate for the use to which the products are placed on the market. In addition, samples of ingredients and of each batch of products manufactured and placed on the market or of each specific portion of production (in the case of continuous production) must be taken in sufficient quantity using a procedure pre-established by the manufacturer and be retained, in order to ensure traceability (on a regular basis in the case of manufacture solely for the manufacturer's own needs). The samples must be sealed and labelled for easy identification; they must be stored under conditions which prevent any abnormal change in the composition of the sample or any adulteration. They must be kept at the disposal of the competent authorities for a period appropriate to the use for which the feed is placed on the market. In the case of feedingstuffs for animals not kept for food production, the manufacturer of the feedingstuff must only keep samples of the finished product.

1. Feed business operators placing on the market fats, oils or products derived thereof intended for use in feed, including compound feed, shall analyse those products in accredited laboratories for the sum of dioxins and dioxin-like PCBs in accordance with Commission Regulation (EC) No 152/2009 ().

2. To supplement the feed business operator's HACCP system, the analyses referred to in point 1 shall be carried out with at least the following frequencies (if not further specified, a batch of products to be analysed shall not exceed 1 000 tonnes):

(a) Feed business operators processing crude vegetable fats and oils:

(i) 100 % of the batches of the products derived from oils and fats of vegetable origin, except for the following:

— glycerine,

— lecithin,

— gums,

— products referred to in (ii);

(ii) acid oils from chemical refining, soap stocks, used filter aids, used bleaching earth and incoming batches of crude coconut oil shall be analysed and documented as part of the HACCP system.

(b) Feed business operators producing animal fat including animal fat processors:

(i) one representative analysis per 5 000 tonnes with a minimum of one representative analysis per year of animal fat and products derived thereof belonging to category 3 material, as referred to in Article 10 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council () or from an establishment approved in accordance with Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council ().