Regulation (EC) No 183/2005 of the European Parliament and of the CouncilShow full title

ANNEX II U.K. REQUIREMENTS FOR FEED BUSINESSES OTHER THAN AT THE LEVEL OF PRIMARY PRODUCTION OF FEED REFERRED TO IN ARTICLE 5(1)

[F1 DEFINITIONS U.K.

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 vegetable oils ’ means any product derived from crude or recovered vegetable oils by oleochemical or biodiesel processing or distillation, chemical or physical refining, other than the refined oil;

(c)

‘ fat blending ’ means the mixing of crude oils, refined oils, animal fats, oils recovered from the food industry and/or products derived thereof to produce a blended oil or fat, with the exception of solely the storage of consecutive batches.]

Textual Amendments

F1 Inserted by Commission Regulation (EU) No 225/2012 of 15 March 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 (Text with EEA relevance).

FACILITIES AND EQUIPMENT U.K.

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. U.K.

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

(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. U.K.

(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. U.K.

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

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

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. U.K.

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

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. U.K.

[F1 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): U.K.

(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 U.K.

Feed businesses must have sufficient staff possessing the skills and qualifications necessary for the manufacture of the products concerned. An organisation chart setting out the qualifications (e.g. diplomas, professional experience) and responsibilities of the supervisory staff must be drawn up and made available to the competent authorities responsible for inspection. All the staff must be informed clearly in writing of their duties, responsibilities and powers, especially when any change is made, in such a way as to obtain the desired product quality.

PRODUCTION U.K.

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

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. U.K.

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. U.K.

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. U.K.

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. U.K.

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

[F1 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: U.K.

• 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 (1) .

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

QUALITY CONTROL U.K.

1. Where appropriate, a qualified person responsible for quality control must be designated. U.K.

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

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. U.K.

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. U.K.

[F1 DIOXIN MONITORING U.K.

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) . U.K.

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: U.K.

(a)

processors of crude vegetable oils:

(i)

100 % of the batches of crude coconut oils shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;

(ii)

100 % of the batches of the products derived from vegetable oils except glycerol, lecithin and gums intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products.

(b)

producers of animal fat:

one representative analysis per 2 000 tonnes of animal fat and products derived thereof belonging to category 3, as laid down in Article 10 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (3) .

(c)

operators of fish oil:

(i)

100 % of the batches of fish oil shall be analysed if it is produced from:

• products derived from crude fish oil other than refined fish oil,

• fisheries with no monitoring history, of unspecified origin or from the Baltic Sea,

• fish by-products from establishments manufacturing fish for human consumption that are not EU approved,

• blue whiting or menhaden,

a batch may comprise at the maximum 1 000 tonnes of fish oil;

(ii)

100 % of the outgoing batches of products derived from crude fish oil other than refined fish oil shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;

(iii)

one representative analysis per 2 000 tonnes shall be carried out, as regards fish oil not referred to in (i);

(iv)

fish oil decontaminated by an officially approved treatment shall be analysed according to the HACCP principles in compliance with Article 6.

(d)

oleochemical and biodiesel industry:

(i)

100 % of the incoming batches of crude coconut oils and products derived from vegetable oils except glycerol, lecithin and gums, animal fats not covered by (b), fish oil not covered by (c), oils recovered from the food industry and blended fats intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;

(ii)

100 % of the batches of products derived from the processing of the products mentioned in (i) except glycerol, lecithin and gums shall be analysed.

(e)

fat blending establishments:

(i)

100 % of the incoming batches of crude coconut oils and products derived from vegetable oils except glycerol, lecithin and gums, animal fats not covered by (b), fish oil not covered by (c), oils recovered from the food industry and blended fats intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;

or

(ii)

100 % of the batches of blended fats intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products.

The feed business operator shall declare to the competent authority in the context of his risk assessment which alternative he chooses.

(f)

producers of compound feed for food producing animals other than those mentioned in (e):

(i)

100 % of the incoming batches of crude coconut oils and products derived from vegetable oils except glycerol, lecithin and gums, animal fats not covered by (b), fish oil not covered by (c), oils recovered from the food industry and blended fats intended for feed shall be analysed. A batch may comprise at the maximum 1 000 tonnes of these products;

(ii)

a sampling frequency of 1 % of the batches shall be carried out as regards manufactured compound feed containing products referred to in (i).

3. If it can be demonstrated that a homogenous consignment is bigger than the maximum batch size according to point 2 and that it has been sampled in a representative way, then the results of the analysis of the appropriately drawn and sealed sample will be considered acceptable. U.K.

4. Where a feed business operator proves that a batch of a product or all components of a batch as referred to under point 2 entering his operation has already been analysed at an earlier stage of production, processing or distribution, or are in compliance with the requirements of points 2(b) or (c)(iii) the feed business operator shall be released from the obligation to analyse this batch and shall analyse it according to the general HACCP principles in compliance with Article 6. U.K.

5. Any delivery of products as referred to under points 2(d)(i), (e)(i) and (f)(i) shall be accompanied by a proof that these products or all components thereof have been analysed or are in compliance with the requirements of points 2(b) or (c)(iii). U.K.

6. If all incoming batches of products mentioned in points 2(d)(i), (e)(i) and (f)(i) entering a production process have been analysed in line with the requirements of this Regulation and if it can be assured that the production process, handling and storage does not increase the dioxin contamination, the feed business operator shall be released from the obligation to analyse the final product and shall analyse it according to the general HACCP principles in compliance with Article 6. U.K.

7. Where a feed business operator mandates a laboratory to perform an analysis, as referred to in point 1 he shall instruct the laboratory to communicate the results of that analysis to the competent authority in case the dioxin limits set out in points 1 and 2 of Section V of Annex I to Directive 2002/32/EC are exceeded. U.K.

Where a feed business operator mandates a laboratory which is located in a 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) No 152/2009.

8. The dioxin testing requirements shall be reviewed by 16 March 2014 .] U.K.

STORAGE AND TRANSPORT U.K.

1. Processed feeds shall be separated from unprocessed feed materials and additives, in order to avoid any cross-contamination of the processed feed; proper packaging materials shall be used. U.K.

2. Feeds shall be stored and transported in suitable containers. They shall be stored in places designed, adapted and maintained in order to ensure good storage conditions, to which only persons authorised by the feed business operators have access. U.K.

3. Feeds shall be stored and transported in such a way as to be easily identifiable, in order to avoid any confusion or cross-contamination and to prevent deterioration. U.K.

4. Containers and equipment used for the transport, storage, conveying, handling and weighing of feed shall be kept clean. Cleaning programmes shall be introduced, and traces of detergents and disinfectants shall be minimised. U.K.

5. Any spoilage shall be minimised and kept under control to reduce pest invasion. U.K.

6. Where appropriate, temperatures shall be kept as low as possible to avoid condensation and spoilage. U.K.

[F1 7. Containers which are to serve for storage or transport of blended fats, oils of vegetable origin or products derived thereof intended for use in feed shall not be used for the transport or storage of products other than these unless the products comply with the requirements of: U.K.

• this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and

• Annex I to Directive 2002/32/EC.

They shall be kept separate from any other cargo where there is a risk of contamination.

Where this separate use is not possible, the containers shall be efficiently cleaned so as to remove any trace of product if those containers were previously used for products not meeting the requirements of:

• this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and

• Annex I to Directive 2002/32/EC.

Animal fats of category 3, as laid down in Article 10 of Regulation (EC) No 1069/2009, intended for use in feed shall be stored and transported in line with that Regulation.]

RECORD-KEEPING U.K.

1. All feed business operators, including those who act solely as traders without ever holding the product in their facilities, shall keep in a register relevant data, comprising details of purchase, production and sales for effective tracing from receipt to delivery, including export to the final destination. U.K.

2. Feed business operators, except those who act solely as dealers without ever holding the product in their facilities, shall keep in a register: U.K.

(a)

Documentation relating to the manufacturing process and controls.

Feed businesses must have a system of documentation designed to define and ensure mastery of the critical points in the manufacturing process and to establish and implement a quality control plan. They must keep the results of the relevant controls. This set of documents must be kept so that it is possible to trace the manufacturing history of each batch of products put into circulation and to establish responsibility, if complaints arise.

(b)

Documentation relating to traceability, in particular:

(i)

for feed additives:

• the nature and quantity of the additives produced, the respective dates of manufacture and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture,

• the name and address of the establishment to which the additives were delivered, the nature and quantity of the additives delivered and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture;

(ii)

for products covered by Directive 82/471/EEC:

• the nature of the products and the quantity produced, the respective dates of manufacture and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture,

• the name and address of the establishments or users (establishments or farmers) to whom these products have been delivered, together with details of the nature and quantity of the products delivered and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture;

(iii)

for premixtures:

• the name and address of the manufacturers or suppliers of additives, the nature and quantity of the additives used and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture,

• the date of manufacture of the premixture and the batch number where appropriate,

• the name and address of the establishment to which the premixture is delivered, the delivery date, the nature and quantity of the premixture delivered, and the batch number where appropriate.

(iv)

for compound feedingstuffs/feed materials:

• the name and address of additive/premixture manufacturers or suppliers, the nature and quantity of the premixture used, with the batch number where appropriate,

• the name and address of the suppliers of the feed materials and complementary feeds and the delivery date,

• the type, quantity and formulation of the compound feed,

• the nature and quantity of feed materials or compound feedingstuffs manufactured, together with the date of manufacture, and the name and address of the buyer (e.g. farmer, other feed business operators).

COMPLAINTS AND PRODUCT RECALL U.K.

1. Feed business operators shall implement a system for registering and processing complaints. U.K.

2. They shall put in place, where this proves necessary, a system for the prompt recall of products in the distribution network. They shall define by means of written procedures the destination of any recalled products, and before such products are put back into circulation they must undergo a quality-control reassessment. U.K.

(1)

[F1 OJ L 140, 30.5.2002, p. 10 .]

(2)

[F1 OJ L 54, 26.2.2009, p. 1 .]

(3)

[F1 OJ L 300, 14.11.2009, p. 1 .]

Textual Amendments

F1 Inserted by Commission Regulation (EU) No 225/2012 of 15 March 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 (Text with EEA relevance).