Rules and Regulations Governing the Export of Fish and Aquatic Products to European Union Member Countries

November 20, 2008

FISHERIES ADMINISTRATIVE ORDER NO. 227-08

 

WHEREAS, the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary (SPS) Measures requires members to base their national SPS measures on international standards, guidelines and other recommendations adopted by the Codex Alimentarius Commission where these exist;

WHEREAS, international trade, investment and market access for fishery products require an increase compliance with SPS requirements;

WHEREAS, RP must respect Codex recommendations that the application of good hygiene and manufacturing practices and HACCP principles by business operators at all stages of production will contribute significantly to ensuring food safety;

WHEREAS, a WTO member country may however apply stricter measures if they can be scientifically justified or if the level of protection afforded by the Codex standards is inconsistent with the level of protection generally applied and deemed appropriate by the country concerned;

WHEREAS, certain fishery and aquatic products may present specific microbiological and chemical hazards, the EU therefore imposes additional and specific hygiene rules for the production and handling of such products, including shellfish;

WHEREAS, RP fish and aquatic business operators and their products exported to the EU must meet at least the same or equivalent hygiene and safety standards as those produced in the EU, including aspects such as veterinary residues, additives, labelling, traceability and materials in contact with food;

WHEREAS, EU requirements are frequently amended as new scientific information becomes available, it is therefore necessary for RP rules also to be easily and quickly adapted; aETAHD

WHEREAS, rules governing export to the EU should not apply to primary production for private domestic use nor to the domestic preparation, handling or storage of food for private domestic consumption;

WHEREAS, Section 62 and Section 65 (I) of Republic Act 8550, the Philippine Fisheries Code of 1998, respectively, mandate the Department of Agriculture — Bureau of Fisheries and Aquatic Resources (DA-BFAR) to set quality grades/standards for all fishery products for export and import, and to implement an inspection system for import and export of fishery/aquatic products and fish processing establishments consistent with international standards to ensure product quality and safety;

WHEREAS, a specific Administrative Order for the production of fishery and aquatic products intended for export to the EU is necessary to enable EU legal requirements to be met;

WHEREAS, classification of shellfish harvesting areas in accordance with EU requirements has not yet been carried out, it is necessary to introduce an extended implementation period for these specific rules;

WHEREAS, EU Commission Decision 95/190/EC recognizes the DA-BFAR as the Competent Authority in the Philippines, mandated to effectively verify the application/enforcement of relevant EU laws and regulations on safety of fishery and aquaculture products;

NOW, THEREFORE, the following rules and regulations governing the production of fish and aquatic products exclusively for export to the EU are hereby promulgated:

CHAPTER I

General Provisions

ARTICLE 1

Scope

1. This Order lays down specific rules on the hygiene of processed and unprocessed FA products for business operators intending to export their products to the EU for human consumption. DAEaTS

2. Unless specifically stated to the contrary, this Order does not apply to processed foods containing both products of plant origin and processed FA products. However, any processed FA products used to prepare such foods must be obtained and handled in accordance with the requirements of this Order.

3. This Order must apply without prejudice to the general requirements of Republic Act No. 8550, Philippine Fisheries Code of 1998, and the following FA Os as applied to the harvesting, production, preparation and processing of FA products for domestic or non-EU markets: AHCETa

a) No. 117: Series of 1975, as amended: Governing the operation of processing plants for FA products and prescribing/requiring standards, quality control and inspection of processed fish and fishery/aquatic products,

b) No. 135: Series of 1981: Governing Importation of Fish and FA Products,

c) No. 192: Series of 1997: Establishing the Fisheries Quarantine Service (FQS) in DA-BFAR,

d) No. 209, Series of 2001: Guideline on the Production, Harvesting, Handling and Transportation of Shellfish for Implementation of the Local Government,

e) No. 210, Series of 2001: Exportation of Fresh, Chilled and Frozen Fish and Fishery/Aquatic Products,

f) No. 211, Series 2001: Pre-processing and Processing Plants, the SSOP thereof and the Processing and Quality Requirements for Shellfish,

g) No. 212, Series 2001: Guideline on the Implementation of HACCP System,

h) No. 214, Series 2001: Code of Practice for Aquaculture; or

i) Fisheries Office Order No. 247, 2006: Powers and Functions of Regulatory Officers for the Safety and Quality Assurance of FA Products Intended for Human Consumption.

4. However, where the provisions of this Order are more stringent as a direct consequence of the requirements of EU legislation, the latter must prevail.

ARTICLE 2

Definitions and Acronyms

1. For the purpose of this Order, the terms, phrases and acronyms defined in Section 4 of the Introduction to the Implementing Code of Practice accompanying this Order ("The Code of Good Manufacturing Practice for Business Operators Exporting Fish and Aquatic Products from the Philippines to the EU, 2008") must apply and have legal effect as if they were an integral part of this Order.

2. The general terms defined in Section 4 of the Introduction to the Implementing Code of Practice for FAO No. 228, Series 2008, "The Code of Good Practice for the Organisation and Implementation of Official Controls for the Export of Fish and Aquatic Products from the Philippines to the EU, 2008" must also apply.

3. The definitions specific to the harvesting and treatment of bivalve molluscs in Chapter IV of these Implementing Codes of Practice must also apply, as appropriate. cAHIST

CHAPTER II

Fishery and Aquaculture Business Operator

Responsibilities

ARTICLE 3

General Obligations

1. FABO must comply with the requirements of the relevant provisions of the PD 856 — Code of Sanitation of the Philippines — and such additional provisions of this Order that are required by EU legislation from time to time in force.

2. FABO must comply with the relevant provisions in Chapters I to V of the Implementing Code of Practice for this Order ("The Code of GMP for Business Operators Exporting FA Products from the Philippines to the EU, 2008") and take all steps necessary to meet the food safety objectives set by this Order.

3. In addition, FABO must ensure that all processed FA products exported to the EU comply with all relevant EU food safety legislation, in particular that relating to:

(i) specified maximum levels for certain contaminants such as histamine, heavy metals, dioxins and PCB-like materials, and polycyclic aromatic hydrocarbons, set out in Chapter III, Section II, Part VII of the Code of Practice referred to in paragraph 2;

(ii) microbiological criteria;

(iii) permitted veterinary drugs and maximum residues arising from their use;

(iv) food contact materials; and

(v) permitted food additives and their conditions of use.

Where no numerical limits are specified in EU legislation, those applicable in recognised international standards, such as Codex Alimentarius, must be applied.

Where EU legislation does not specify the sampling or analysis methods, FABO may use other methods providing they give results equivalent to the EU reference method, and have been scientifically validated in accordance with internationally recognised protocols.

4. FABO must not use any substance other than potable water or, when appropriate clean water or clean seawater, in contact with FA products, unless DA-BFAR has specifically authorised such use, and any necessary conditions of use, in accordance with EU requirements.

5. FABO must at all times cooperate with DA-BFAR during Official Controls carried out in accordance with FAO No. 228, Series 2008 (laying down specific rules for the organization of Official Controls on FA products intended for export to the EU for human consumption).

ARTICLE 4

Hazard Analysis and Critical Control Point Systems

1. FABO must establish and operate permanent procedures based on the HACCP principles in order to:

(a) identify any hazards that must be prevented, eliminated or reduced to acceptable levels;

(b) identify the CCPs at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels; ADCEaH

(c) establish critical limits at CCPs which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards;

(d) establish and implementing effective monitoring procedures at CCPs;

(e) establish corrective actions when monitoring indicates that a CCP is not under control;

(f) establish procedures, which must be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively; and

(g) establish documents and records commensurate with the nature and size of the food business to demonstrate effective application of the measures outlined in subparagraphs (a) - (f). EAISDH

2. Where FABO can satisfy DA-BFAR that it would be disproportionate to operate a full HACCP system, they must have a food control programme, based on a simplified HACCP system and the correct implementation of appropriate GAqP, GHP and GMP, in order to:

(a) identify relevant hazards and steps in their operations which are critical to the safety of their FA product;

(b) implement effective control procedures at those steps;

(c) monitor control procedures to ensure their continuing effectiveness;

(d) review control procedures at an appropriate frequency.

3. When any modification is made to the product or process, FABO must review their control procedures and make any changes necessary to ensure FA product safety.

4. FABO must ensure that documents describing procedures developed in accordance with this Article:

(a) provide DA-BFAR with evidence of compliance with paragraph 1, in the manner that DA-BFAR requires;

(b) are up-to-date at all times;

(c) are retained for an appropriate period based on the shelf-life of the product, or other period that DA-BFAR may specify;

(d) are made available to DA-BFAR on demand.

These documents must include, as necessary, records of monitoring and control activities in accordance with the HACCP plan, such as sanitation checks, temperature, pest control, instrument calibration, medical and training certificates, and product traceability.

ARTICLE 5

Registration and Approval of Establishments

1. FABO must process and export FA products only if they have been obtained from, prepared and handled exclusively in establishments that:

(a) meet the applicable requirements of the Implementing Code of Practice to this Order ("The Code of GMP for FABO Exporting FA Products from the Philippines to the EU, 2008") and other relevant requirements of EU and RP food law; and

(b) DA-BFAR has inspected, approved and registered, in accordance with FAO No. 228, Series 2008, laying down rules for the organization and implementation of official controls on fishery and aquaculture products intended for export to the EU for human consumption. cDAITS

2. FABO must comply with the administrative requirements on the registration and approval of the establishments, as set out in FAO No. 228, series 2008 ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption") and FAO No. 210, 2001 ("Export of Fresh, Chilled and Frozen Fish and FA products").

3. FABO must at all times cooperate with DA-BFAR during the registration and approval process, in particular by:

(a) notifying DA-BFAR of each establishment under his control that carries out any of the stages of production, processing and export of FA products; and

(b) ensuring that DA-BFAR has up-to-date information on such establishments, including any significant change in activities and any closure of an existing establishment.

ARTICLE 6

Imported Products

1. In addition to relevant requirements of FAO No. 135, 1981, and FAO 195, 1999, (Fish and FA Products Import Rules), FABO must ensure that any imported FA products intended for export to the EU, whether or not having been subjected to further processing, have been obtained as follows:

(a) the country of origin appears on the list of non-EU countries from which the specific FA products may be imported into the EU;

(b) the establishments from which the product was obtained, and in which it was obtained or prepared, appear on a list of establishments from which the specific FA products may be imported into the EU;

(c) in the case of live bivalve molluscs, echinoderms, tunicates and marine gastropods, the production area appears on the current EU list; and

(d) the requirements of the EU and DA-BFAR concerning certificates and documents are satisfied.

2. FABO importing food containing both products of plant origin and processed FA products, to be further processed and/or otherwise handled prior to export, must ensure that the processed FA products contained in such food satisfy the requirements of paragraph 1.

3. FABO must be able to demonstrate to DA-BFAR that they have complied with paragraphs 1 and 2 through appropriate national or international certification, or through other appropriate documentation.

ARTICLE 7

Identification Marking

FABO must ensure that FA products intended for export have an Identification Mark applied in accordance with the provisions of Chapter V of the Implementing Code of Practice to this Order, and the requirements of FAO No. 228, Series 2008 ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption"). cISDHE

FABO must only apply an Identification Mark if the product has been produced in accordance with this Order.

ARTICLE 8

Sanitary/Health Certificates

1. FABO must ensure that official sanitary/health certificates accompany consignments of exported FA products.

2. Sanitary/health certificates must be issued by BFAR in accordance with Article 11 and Chapter V of FAO No. 228, Series 2008 ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption") and its Implementing Code of Practice, respectively.

3. This Article must be without prejudice to the relevant requirements for inspection and certification in respect of fishery pests and diseases by the Fisheries Quarantine Service established under FAO No. 192, 1997.

ARTICLE 9

Traceability

1. FABO must operate traceability procedures for ingredients, raw materials and FA products, at all stages of production, processing and distribution, and be able to:

(a) identify any person or business that has supplied them with any food or feed product or substance intended, or likely to be, incorporated into FA products;

(b) identify businesses to which they have supplied their products; and

(c) provide this information to DA-BFAR on demand.

2. FA products intended for export must be adequately labelled or otherwise identified through relevant documentation and the application of an appropriate production/batch code.

3. Subject to the additional information that may be required under paragraph 4, FABO must provide:

(a) the scientific name of the fish species used;

(b) the production method, described as follows, according to whether the fish was caught, at sea or in freshwater, or farmed:

(i) in English; '. . . caught . . .' or '. . . caught in freshwater . . .' or '. . . farmed . . .' or '. . . cultivated . . .'; or

(ii) as specified in the Official language of the Member State of destination.

(c) an indication of the catch area, consisting of the following:

(i) for products caught at sea, a reference to the appropriate Food and Agriculture Organisation designated catch area (zone) given in Chapter VI of the Code of Practice;

(ii) for products caught in freshwater, a reference to the Philippines as the origin of the product;

(iii) for farmed products, a reference to the Philippines as the country in which the product undergoes the final development stage. Where the product is obtained from farms in more than one country, this fact may also be required. DCATHS

Operators may indicate a more precise catch area.

4. Where a consignment or product contains a single species from a variety of origins or a combination of species, additional information must be provided, as appropriate to the following cases:

(a) different fish species: the scientific name for each;

(b) the same species, but derived from a variety of production methods: the method for each batch;

(c) the same species, but derived from a variety of catch areas or fish farming countries:

(i) at least the catch area of the batch which is most representative in terms of quantity; and

(ii) a statement that the products also come from different catch or fish farming areas.

ARTICLE 10

Amendment and Adaptation

1. This Order and the Implementing Code of Practice may be amended or supplemented with the inclusion of such other standards, practices and requirements that may be developed by DA-BFAR, acting on its own initiative, or to incorporate those of relevant government agencies or international bodies. Such changes must be adopted and promulgated by DA-BFAR through legally-binding amendments or supplementary issuances.

In particular, the requirements in the Chapters of the Code of Practice may be amended to take into account changes that may be specified by the EU as a result of scientific and technical developments.

2. FABO exporting FA products must be aware of, and comply with, the EU requirements from time to time in force and, in particular, revisions to those indicated in Article 3.3, and:

(a) additional health standards or checks that may have been introduced by the EU;

(b) freshness criteria and limits with regard to histamine and total volatile nitrogen;

(c) health standards and processing requirements for live bivalve molluscs, including:

(i) limit values and testing methods for biotoxins;

(ii) virus testing procedures and virological standards; and

(iii) sampling plans, methods and analytical tolerances to be applied during compliance checks;

(iv) treatments that may be applied in a processing establishment to live bivalve molluscs from class B or C production areas that have not been submitted to purification or relaying; CSAaDE

(v) requirements of Article 10 of FAO No. 228, Series 2008 ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption") relating to live bivalve molluscs.

ARTICLE 11

Penalty and Other Provisions

1. Penalties — (a) The Local Government Unit (LGU) concerned shall by appropriate ordinance penalize fraudulent practices which maim the quality grades/standards for all fishery products for export and import, in violation of section 62 of RA 8550.

(b) For violation of Section 65 (I) of RA 8550 — Any importation or exportation of fish and fisheries species shall be punished by eight (8) years of imprisonment, a fine of eighty thousand pesos (P80,000.00) thousand pesos and destruction of live fishery species and forfeiture of non-live fishery species in favour of DA/BFAR for its proper disposition: Provided that violation of this provision shall be banned from being member or stockholder of companies currently enjoyed in fisheries or companies to be created in the future, the guidelines from which shall be promulgated by DA/BFAR.

2. Revocation — Any provisions in previous orders, rules and regulations inconsistent with the provisions of this Order are revoked and superseded accordingly.

3. Separability Clause — If any portion or provision of this Order is declared unconstitutional or invalid, the other portion or portions thereof, which are not affected thereby, must continue in full force and effect.

4. Effectivity

This Order must take effect 15 days after its publication in Official Gazette and/or in two (2) newspapers of general circulation and fifteen (15) days after its registration with the office of the National Administrative Register.

Except that, without prejudice to the safety of any live bivalve mollusc supplied for export to the EU, the specific provisions of any Articles of this Order and Chapter IV of the Code of Practice related to the classification of harvesting areas for live bivalve molluscs must come into effect one year after its effectivity.

Issued this 20th day of November year 2008 at Quezon City Philippines. cTaDHS

SIGNED BY:

(SGD.) ARTHUR C. YAPSecretary, Department of Agriculture

RECOMMENDED BY:

(SGD.) MALCOLM I. SARMIENTO, JR.Director, Bureau of Fisheries and Aquatic Resources

(SGD.) EMMANUEL J. PARASChairman, National Fisheries and Aquaculture Management Council

ATTACHMENT

CODE OF PRACTICE

"RULES AND REGULATIONS GOVERNING THE EXPORT OF FISH AND AQUATIC PRODUCTS TO THE EUROPEAN UNION"

SECTION 1. Title. — This Code must be known as "The Code of Good Manufacturing Practice for Business Operators Exporting Fish and Aquatic Products from the Philippines to the European Union, 2008".

Rule 1.1. Purpose. — This Code is promulgated to prescribe the procedures and guidelines for the implementation of the FAO No. 228, Series of 2008, to facilitate compliance therewith and achieve the objectives thereof.

SECTION 2. Declaration of Policy. — It is the declared policy of the DA-BFAR to ensure:

(i) all Philippine businesses producing fishery and aquatic products for export to the European Union meet the additional and specific hygiene rules imposed by EU for these products, including shellfish;

(ii) the implementation of procedures based on the Codex HACCP principles, together with the application of good hygiene practices at all stages of the supply and production chain, in line with national and EU requirements;

SECTION 3. Application of its Provisions. — The provisions of this Code must be enforced in all fishery and aquatic products businesses and establishments, including aquaculture and freezer and factory vessels, whether private or public.

Rule 3.1. Jurisdiction. — The Department of Agriculture, through the Bureau of Fisheries and Aquatic Resources (DA-BFAR), in co-operation with concerned LGU's and national agencies, must have the responsibility and jurisdiction in the application of these rules and the inspection of all fisheries and aquatic businesses to which they apply. However, the DA-BFAR may coordinate with other government agencies and LGU to which specified Official Control responsibilities have been delegated under the terms of the FAO No. 228, Series 2008, ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption").

SECTION 4. Definition of Terms. — As used in this Code, but without prejudice to their use in the Fisheries Administrative Orders listed in Article 1.3, the following definitions must apply: IHcSCA

Rule 4.1. Terms and phrases. —

Approval — procedure wherein DA-BFAR formally recognises an establishment as meeting the requirements of this Order and being competent to carry out the required HACCP program;

Approval Number — a number assigned to a fishery establishment by DA-BFAR certifying its compliance with the requirements of this Order;

Aquaculture — fishery operations involving all forms of breeding, raising and farming of fish and other fishery species in fresh, brackish and marine water areas, by means of hatcheries, cages, pens, ponds and similar operations as defined in FAO No. 214, Series 2001;

Bivalve molluscs — filter-feeding lamellibranch molluscs, such as oysters, mussels, clams and scallops;

Certificate of Registration (COR) — is an official document issued only by DA-BFAR attesting that the product concerned is obtained from duly registered aquaculture farms;

Chilled fish — fresh fish that has been subjected to zero degree Celsius (0ºC);

Clean seawater — natural, artificial or purified seawater or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food;

Clean water — clean seawater and fresh water of a similar quality;

Competent Authority — DA-BFAR, or other officially-designated national and regional authority having the legal competence to enforce relevant national and international food safety regulations, and to verify and certify compliance with the regulatory requirements applied to the export of FA products to the EU;

Contaminant — any biological or chemical agent, foreign matter, or other substances not intentionally added to food which may compromise food safety or suitability;

Contamination — the presence or introduction of a contaminant;

Cross Contamination — Contamination of raw materials, in-process and finished products brought about by other ingredients;

Control body — an independent third party to which DA-BFAR has formally delegated certain specified control tasks;

Critical Control Point (CCP) — a step in the production and processing chain where activities are carried out, or conditions prevail which can influence the safety of the product, and where control can be exercised over one or more factors to prevent or eliminate the hazard or reduce it to an acceptable level;

Establishment — any unit of a food business comprising the site, buildings and other structures, but excluding those such as administrative offices where food is not handled and those where food handlers do not enter;

European Union (EU) — one or more of the EU territories listed in Chapter VIII; the term must be considered as synonymous with the European Community;

Export — the commercial despatch of fishery and aquatic products to the EU, whether or not for profit;

Factory vessel — any vessel on board which fishery products undergo one or more of the following operations followed by wrapping or packaging and, if necessary, chilling or freezing: filleting, slicing, skinning, shelling, shucking, mincing or processing;

Fish — includes all fish and other aquatic species such as crustaceans (crabs, prawns, shrimps and lobsters), cephalopods (squid, cuttlefish and octopus), molluscs (clams, mussels, scallops and oyster) and gastropods (snails); TaSEHC

Fish inspection — assessment of the capability of fish processing plants to implement and comply with food safety and quality control measures prescribed in this FAO;

Fish Processing Establishment — any premises or facility where fish and fishery/aquatic products are handle, prepared and/or processed, packaged or stored; synonymous with Fishery establishment;

Fisheries — all activities relating to the act or business of fishing, culturing, preserving, processing, marketing and exporting aquatic resources;

Fishery and Aquatic Products (hereafter, FA products) — products of aquatic animals or parts thereof, including finfish and all crustaceans, molluscs, echinoderms and other aquatic products, seawater and freshwater animals, in whatever form whether fresh, chilled, frozen or processed, including fish oils, squalene and blubbers intended for human consumption;

Fishery/Aquatic Products Business — any public or private business engaged in commercial activities related to any stage of production, processing and distribution of FA products for export to the EU;

Fishery/Aquatic Products Business Operators ('FABO') — the natural or legal entity, such as individuals, associations, partnerships, cooperatives or corporations, responsible for ensuring that requirements of food law are met within the FA business under their direct control, and the management within the establishment to whom such responsibility has been delegated;

Fishery Establishments — any unit of a food business including fish pond, hatcheries, companies, freezing and cold storages, ice plant, processing plant, pre-processing plant, fish landing sites/ports, auction/wholesale markets, and all other businesses involved in the food chain;

Fishing vessel — any boat, ship, or other watercraft equipped to be used for taking of live fish and aquatic species or aiding or assisting one or more vessels in the performance of any activity relating to fishing, including supply, preservation, storage, transportation and/or processing;

Food hygiene — the measures and conditions necessary to control hazards and to ensure fitness for human consumption of the food taking into account its intended use;

Food safety — the assurance that food is processed properly and when consumed will not be harmful to the consumers;

Freezer vessel — any vessel on board which freezing of fishery products is carried out, where appropriate after preparatory work such as bleeding, heading, gutting and removal of fins and, where necessary, followed by wrapping or packaging;

Fresh fishery products — unprocessed fishery products, whether whole or prepared, including products packaged under vacuum or in a modified atmosphere, that have not undergone any treatment, other than chilling to ensure preservation;

Frozen fish — fish which has been subjected to a freezing process to reduce its temperature to, and maintain it at, minus 18 degrees Celsius (-18ºC) in order to preserve its quality;

Good Aquaculture practices (GAqP) — use of responsible aquaculture according to guidelines agreed between DA-BFAR and stakeholders; Fisheries AO No. 214, 2001: "Code of Practice for Aquaculture";

Good Manufacturing Practices (GMP) — a set of guidelines implemented in the fishery establishments and processing plants to ensure product safety and quality, and which includes adherence to rules and regulations relating to plant construction, sanitary operation and personnel hygiene; AaIDHS

Growing area — an area in the sea, estuarine or lagoon containing a natural species of shellfish; a site for the culture of shellfish;

HACCP — preventive quality management system, defined by Codex Alimentarius, that identifies, evaluates and controls hazards that are significant to the safety of a specific product; (Hazard Analysis and Critical Control Points system);

HACCP Compliance Certificate — a written document issued by DA-BFAR attesting that the establishment is HACCP compliant;

HACCP Plan — a company's written document defining the formal procedures to be followed in accordance with the seven Codex HACCP principles;

Hazard — a biological, chemical or physical agent in, or condition of, food or feed with the potential to cause an adverse health effect on humans or aquatic organisms;

Identification Mark — a mark applied to the wrapping or packaging of FA products by FABO to indicate that the establishment in which the products have been produced has been approved by Official Controls carried out in accordance with FAO No. 228, Series 2008, "Rules governing the organization and implementation of official controls on fishery and aquatic products intended for export to the EU market for human consumption";

Mechanically separated fishery product — any product obtained by removing flesh from fishery products using mechanical means that result in the loss or modification of the flesh structure;

Microbiological criteria — criteria defining the acceptability of a product, a batch of fishery products or a process, based on the absence, presence or number of micro-organisms, and/or on the quantity of their toxins/metabolites, per unit(s) of mass, volume, area or batch;

Monitor — the act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control;

Packaging — the placing of one or more wrapped foodstuffs in a second container, and the latter container itself;

Post-harvest facilities — these facilities include, but are not limited to, fish port, fish landing, ice plants and cold storages, fish processing plants;

Potable water — water meeting the minimum requirements laid down in the EU Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption, as set out in Chapter VII of this Code of Practice; TECIaH

Prepared fishery products — unprocessed fishery products that have undergone an operation affecting their anatomical wholeness, such as gutting, heading, slicing, filleting, and chopping;

Pre-processing plant or establishment — a facility where preliminary processing or preparation of product is undertaken;

Processed fishery products — processed products resulting from the processing of fishery products or from the further processing of such processed products;

Processing — any action that substantially alters the initial product such as heating, steaming, smoking, curing, maturing, drying, marinating, or a combination of these processes, but does not include those processes regarded as resulting in 'unprocessed products', below;

Registration — the process by which all post-harvest facilities such as fish processing plants, ice plants, and cold stores, fish ports/landings and other fishery business establishments are registered with, and licensed by the LGUs, respecting the minimum standards prescribed for such facilities by DA-BFAR;

Risk — a function of the probability of an adverse health effect and the severity of that effect, consequential to a hazard; ISADET

Sanitary/Health Certificate — a document issued by DA-BFAR attesting that the FA product has been derived and manufactured in conformity with established EU sanitary standards and health requirements;

Sanitation Standard Operating Procedures (SSOP) — written procedures to be followed to ensure that processing and production are carried out under sanitary and hygienic conditions to achieve food safety;

Shellfish — all species of univalves and bivalves which are filter feeders, such as lamellibranch molluscs and gastropods;

Traceability — the ability to trace and follow a FA product through all stages of production, processing and distribution from and including primary production up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the import, production, manufacture, storage, transport, distribution, sale and supply of any ingredient or feed used in its production or preparation;

Un-processed — FA product that has not undergone processing; this includes products that have been gutted, cleaned, filleted, cut, sliced, boned, minced, skinned, trimmed, chilled, frozen, deep frozen or thawed. However, deep-frozen bivalves must be regarded as "processed products" for the purposes of this Order;

Wrapping — the placing of a FA product in a wrapper or container in direct contact with the product concerned, and the wrapper or container itself.

Rule 4.2. The terms 'where necessary','where appropriate','adequate' and 'sufficient' must mean, respectively, where necessary, where appropriate, adequate or sufficient to achieve the objectives of the Fisheries Administrative Order No. 228, 2008, and this Code of Practice.

Rule 4.3. The following acronyms must refer to:

BFAR	—	Bureau of Fisheries and Aquatic Resources
CA	—	Competent Authority
DA	—	Department of Agriculture
EU	—	European Union (also European Community)
FA product	—	Fishery and Aquatic product
FABO	—	Fishery and Aquatic products Business Operators
FAO	—	Fisheries Administrative Order
GAqP	—	Good Aquaculture Practices
GHP	—	Good Hygiene Practices
GMP	—	Good Manufacturing Practices
HACCP	—	Hazard Analysis and Critical Control Point
LGU	—	Local Government Unit
SPS	—	Sanitary and Phytosanitary Measures
SSOP	—	Sanitation Standard Operating Procedures
WTO	—	World Trade Organization

CHAPTER I

Primary Production and Associated Operations

PART I

Scope

1. This Chapter applies to FABO conducting primary production and associated operations for raw materials used in the production and processing of FA products intended for export. HcSaTI

2. For the purposes of this Annex:

"primary production" includes the farming, fishing and collection of live fishery products; and "primary products" must be construed accordingly;

"associated operations" includes:

(i) heading, gutting, cleaning, removing fins, refrigeration and wrapping if carried out on board fishing vessels;

(ii) transport, storage and handling of live fishery products, and primary products which have not been substantially altered, at the place of production and/or within fish farms on land; and

(ii) n transport of such products from the production place to the first establishment of destination.

PART II

Hygiene Provisions

1. FABO must ensure that primary products are protected, as far as reasonably possible, against contamination, having regard to any processing that they will subsequently undergo.

2. FABO must comply with appropriate EU and RP legislative provisions relating to the control of hazards in primary production and associated operations, including measures: IDCcEa

(a) to control contamination arising from the air, soil, water, feed, veterinary medicinal products, plant protection products and biocides and the storage, handling and disposal of waste; and

(b) relating to fish health that have implications for human health.

3. FABO farming, harvesting or catching primary fish products must take appropriate measures to:

(a) keep clean and, where necessary after cleaning, disinfect in an appropriate manner:

(i) any facilities, including those used to store and handle feed;

(ii) equipment, containers, crates, vehicles and vessels;

(b) use potable water, or clean water, whenever necessary to prevent contamination;

(c) use feed additives and veterinary medicines in accordance with relevant EU and Philippine legislation;

(d) store and handle waste and hazardous substances in a way that prevents contamination;

(e) as far as possible, prevent animals and pests from causing contamination;

(f) ensure that staff handling FA products are in good health and undergo training on health risks;

(g) prevent the introduction and spread of zoonotic agents through FA products, including by taking precautionary measures when introducing new fish or shellfish and by reporting suspected outbreaks of such diseases to BFAR Director.

4. FABO must take account of analyses carried out on samples taken from FA products or other samples important to human and/or fish health and must take appropriate remedial action when informed of problems identified during Official Controls. ECHSDc

PART III

Record-Keeping

1. FABO must keep and retain records of measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the business, and to make relevant information contained in these records available to DA-BFAR and receiving FABO on request.

2. Primary producers of FA products must, in particular, keep records on:

(a) the nature and origin of feed fed to the fish;

(b) veterinary medicines or other treatments administered to the fish, administration dates and withdrawal periods;

(c) the occurrence of diseases that may affect the safety of FA products;

(d) the results of any analyses carried out on samples taken from fish, or other samples taken for diagnostic purposes, that have importance for human health; and

(e) any relevant reports on checks carried out on FA products.

3. FABO may be assisted by other persons, such as veterinarians or other appropriate specialists, with the keeping of records.

CHAPTER II

General Hygiene Requirements for Food and Aquatic Business Operators

(except Primary Producers covered by CHAPTER I)

SECTION I

General Requirements for Premises and Establishments

1. Premises and establishments must be kept clean and maintained in good repair and condition.

2. The layout, design, construction, siting and size of FA product premises and establishments must:

(a) permit adequate maintenance, cleaning and/or disinfection, avoid or minimise air-borne and other contamination;

(b) protect against the accumulation of dirt, contact with toxic materials, the shedding of particles into FA products and the formation of condensation or undesirable mould on surfaces;

(c) permit GHP and, in particular, pest control;

(d) provide adequate working space to enable the hygienic performance of all operations;

(e) where necessary, provide suitable temperature-controlled handling and storage conditions with sufficient capacity to maintain FA products at appropriate temperatures and permit those temperatures to be monitored and, where necessary, recorded.

3. FABO manufacturing, handling and wrapping processed FA products must have suitable rooms, large enough for the storage of raw materials separate from processed material, and sufficient separate refrigerated storage.

4. An adequate number of flush lavatories must be available, in working order, and connected to an effective drainage system. Lavatories must have adequate natural or mechanical ventilation and must not open directly into rooms in which FA products are handled.

5. An adequate number of washbasins must be available, suitably located and designated for cleaning hands. They must be provided with hot and cold running water, materials for cleaning hands and for hygienic drying; they must be separate from any facilities required for washing FA products.

6. There must be suitable and sufficient natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area must be avoided. Ventilation inlets must be screened or otherwise protected against access to pests and particulate contamination. Ventilation systems must be constructed to enable filters and other parts requiring cleaning or replacement to be readily accessible. SEcAIC

7. Food premises must have adequate natural and/or artificial lighting. Fittings must be shatterproof or provide alternative protection to products in case of breakages.

8. Drainage facilities must be adequate for their intended purpose, and designed and constructed to avoid the risk of contamination. Where drainage channels are fully or partially open, they must be designed to ensure that waste does not flow from a contaminated area towards or into a clean area where FA products are handled.

9. Where necessary, adequate hanging facilities for personnel must be provided. These must be directly connected to, but separate from processing areas.

SECTION II

Structural Requirements in Rooms where FA Products are Prepared, Treated or Processed

1. The design and layout of rooms in which FA products are prepared, treated or processed (excluding dining areas, but including rooms contained in means of transport) must meet the general requirements of Section I, paragraphs 1 and 2, and in particular:

(a) surfaces such as floors, walls and doors in areas where FA products are handled and, in particular, surfaces of equipment in direct contact with food must be maintained in a sound condition and be easy to clean and, where necessary, disinfect. Surfaces must be made from smooth, washable, corrosion-resistant and non-toxic materials, and in the case of equipment, meet the requirements of Section III of this Chapter;

(b) where appropriate, floors must allow adequate surface drainage;

(c) walls must have a smooth surface up to a height appropriate for the operations;

(c) ^* ceilings (or, where there are no ceilings, the interior surface of the roof) and overhead fixtures must be constructed and finished to prevent accumulation of dirt and to minimise condensation, growth of undesirable mould and shedding of particles;

(d) windows and other openings must be constructed to prevent accumulation of dirt. Those which can be opened to the outside environment must be fitted with insect-proof screens which can be easily removed for cleaning.

(e) windows and doors must be tight fitting and, when closed, sealed against entry by pests.

2. Adequate facilities must be provided, where necessary, for cleaning, disinfecting and storage of working utensils and equipment. These must be constructed of corrosion-resistant materials, be easy to clean and have an adequate supply of hot and cold water.

3. Adequate provision must be made, where necessary, for washing FA products. Every sink or other such facility must have an adequate supply of hot and/or cold potable water consistent with the requirements of Section VII and be kept clean and, where necessary, disinfected.

SECTION III

Equipment Requirements

1. All articles, fittings and equipment with which FA products come into contact must be:

(a) designed and constructed of such materials, and kept in good condition, to minimise any risk of contamination; equipment should be free from hollow sections where food could accumulate; food contact surfaces should be sealed against accumulation of particles;

(b) effectively cleaned and, as necessary, disinfected to avoid any risk of contamination;

(c) constructed with materials that comply with relevant EU requirements for food contact materials; STIEHc

(d) installed in a manner that allows adequate cleaning of the equipment and the surrounding area.

2. Where necessary, equipment must be fitted with appropriate control device(s). These must be kept in good operating condition and calibrated at appropriate frequencies; calibration records must be kept for an appropriate period.

3. Chemicals used to prevent corrosion of equipment and containers must be used in accordance with GMP.

SECTION IV

Water Supply

1. There must be an adequate supply of potable water, meeting the criteria in Section VII of this Code of Practice. This must be delivered at an appropriate temperature and pressure, from approved public or private water supply systems, and used whenever necessary to ensure that FA products are not contaminated.

On-site water filters, settling tanks, and other treatment facilities must be cleaned as often as necessary to keep them operational and in a sanitary condition.

However,

(a) clean water may be used with whole fishery products;

(b) clean seawater may be used with live bivalve molluscs, echinoderms, tunicates and marine gastropods;

(c) clean water may also be used for external washing.

When such water is used, adequate facilities must be available for its supply.

2. If non-potable water is used, for example for fire control, steam production, refrigeration and similar purposes, it must circulate in a separate, clearly-identified system. Non-potable water must not connect with, or be allowed to reflux into, potable water systems.

3. Recycled water used in processing or as an ingredient must not present a risk of contamination and must be of the same standard as potable water, unless DA-BFAR is satisfied that its quality cannot affect the wholesomeness of the finished FA product.

4. Ice which comes into contact with FA products must be made from potable water or, when used to chill whole fishery products, clean water. It must be made, handled and stored under conditions that protect it from contamination.

5. Steam used directly in contact with FA products must not contain any substance that presents a hazard to health or is likely to contaminate the products.

6. If heat treatment is applied to FA products in hermetically sealed containers, water used to cool the containers after heat treatment must not be a source of contamination.

SECTION V

Provisions Applicable to FA Products

1. FABO must not accept raw materials or ingredients, other than live fish, or any other material used in processing products if they are known, or might reasonably be expected, to be contaminated with parasites, pathogenic microorganisms or toxic, decomposed or foreign substances to an extent that, even after normal sorting, preparation and processing, the final product would be unfit for human consumption. EHIcaT

2. Raw materials and ingredients must be stored in appropriate conditions, designed and operated to prevent harmful deterioration and to protect them from contamination.

3. At all stages of production, processing and distribution, FA products must be protected against any contamination likely to render the product unfit or unsafe for human consumption.

4. Adequate procedures must be in place to control pests and to prevent domestic animals from having access to places where FA products are prepared, handled or stored or, where DA-BFAR so permits in special cases such as police or drug sniffer dogs, to prevent such access from resulting in contamination:

(a) doors must be tight-fitting, adequately sealed against entry by pests, and kept closed during production, except when in use;

(b) where open windows would result in contamination, they must remain closed and fixed during production.

5. Raw materials, ingredients, intermediate products and finished products that may support the growth of pathogenic micro-organisms or the formation of toxins must be kept at temperatures that minimise any health risk.

However, limited periods outside temperature control are permitted, to accommodate practicalities of handling during production, transport and storage, provided this does not result in a health risk.

6. FA products must be thawed, and subsequently handled, at temperatures that do not result in a risk to health, and in a way that minimises the risk of growth of pathogenic microorganisms or the formation of toxins. When run-off liquid from thawing may present a health risk, it must be adequately drained.

7. Hazardous and/or inedible substances, including animal feed, must be adequately labelled and stored in separate and secure containers.

8. Cleaning agents and disinfectants must not be stored in areas where food is handled.

SECTION VI

Heat Treatment

The following requirements apply only to FA products exported in hermetically sealed containers:

1. The heat treatment used to process an unprocessed FA product or to process further a processed FA product must:

(a) raise every part of the product to the necessary temperature for the specified period of time; and

(b) prevent the product from becoming contaminated during the process.

2. FABO must check regularly the main relevant parameters (particularly temperature, pressure, sealing and microbiology), including by the use of automatic devices, to ensure that the treatment achieves the desired objectives.

3. The treatment should conform to an internationally recognised standard (for example, pasteurisation, ultra high temperature or sterilisation).

SECTION VII

Wrapping and Packaging of FA Products

1. Wrapping and packaging materials must:

(a) comply with relevant EU requirements for food contact materials;

(b) not be a source of contamination; EITcaH

(c) be stored in a manner that does not expose them to a risk of contamination;

(d) if intended for re-use, be easy to clean and, where necessary, to disinfect.

2. Wrapping and packaging operations must be carried out in a way that avoids contamination of FA products. Where appropriate and, in particular, in the case of cans and glass jars, the integrity of the container's construction and its cleanliness must be assured by appropriate checks.

3. Receptacles in which fresh FA products are kept under ice must be water-resistant and ensure that melt-water does not contaminate the products.

4. Frozen blocks prepared on board vessels must be adequately wrapped before landing.

SECTION VIII

Storage of FA Products

PART A

Storage Temperatures

FA products must be maintained at the required temperature. In particular:

1. Fresh products, thawed unprocessed products, and cooked and chilled products from crustaceans and molluscs, must be maintained at a temperature approaching that of melting ice (0ºC - 4ºC).

2. Frozen products must be kept at a temperature of -18ºC or colder in all parts of the product, with short upward fluctuations of not more than 3ºC being permitted;

3. However, whole frozen fish in brine intended for canning may be kept at a core temperature of -9ºC or colder.

4. Live products must be kept at an appropriate temperature and in a manner that does not adversely affect food safety or their viability.

5. All temperature monitoring equipment must undergo regular, annual internal and external calibration.

PART B

Storage Management

Appropriate procedures must be in place for sanitary handling of products during storage and distribution.

1. Raw materials, packaging materials, part-processed and finished products, cleaning chemicals, equipment and machinery spares should be stored, where possible, in separate storage areas.

2. Materials and products should be stored in a way that permits effective cleaning, pest control, inspection and sampling, retention of product or batch identity, and effective stock rotation.

3. Stored finished products must be protected against physical, chemical, and microbial contamination and deterioration of the product and its packaging due to pests, toxic chemicals, sources of undesirable flavour and odour, and from excesses of heat and light:

(a) storage areas should be kept free from rodents, insects, birds and other pests; external doors should not be left open;

(b) toxic chemicals such as pesticides, disinfectants, or other potential contaminants must not be stored close to products or raw materials; separate locked storage should be provided for these materials; cHAaCE

(c) potentially contaminated incoming materials must not be stored next to finished products;

(d) defective or suspect goods must be stored in a separate area, preferably locked;

(e) storage facilities must be secured to protect against tampering, theft, etc.;

(f) stock control and rotation systems should be operated; product traceability must be ensured;

(g) storage premises and areas must be kept clean and tidy to minimise places or food sources for pests. Product spillages should be removed quickly.

4. Protective clothing must be worn where applicable.

PART C

Warehouses and Storage Rooms

1. Storage buildings and rooms must comply with the requirements of Section I, paragraphs 1 and 2. Lighting, temperature, humidity control and ventilation should be appropriate to the products being stored.

2. Buildings and rooms must be adequately proofed against entry of pests; suitable curtains should be provided at entrances to maintain the internal conditions at an appropriate level and to deter flying pests.

3. Where the product is susceptible to temperature abuse and/or weather damage, covered bays should be provided for loading and unloading.

SECTION IX

Transport of FA Products

1. Containers and the storage areas in vehicles must be kept clean and maintained in good condition to protect FA products from contamination and, where necessary, designed and constructed to permit adequate cleaning and/or disinfection.

2. Vehicles and/or containers must not be used for transporting non-food materials where this may result in contamination. However, where vehicles and/or containers are used for transporting anything:

(i) in addition to FA products or for transporting different foods at the same time, the products must be effectively separated, as necessary;

(ii) other than foodstuffs or for transporting different foodstuffs, there must be effective cleaning between loads to avoid the risk of contamination.

3. FA products must be placed and protected in vehicles and/or containers in a way that minimises the risk of contamination.

4. Where necessary, vehicles and/or containers must be capable of maintaining FA products at the temperatures specified in Section VIII, Part A and allow those temperatures to be monitored.

However, Section VIII, Part A.2 need not be met when frozen FA products are transported from a cold store to an approved establishment, to be thawed on arrival for the purposes of preparation and/or processing, providing the travel time is short and DA-BFAR so permits.

5. Fish and shellfish to be exported live must be transported in a way that does not adversely affect food safety or their viability. ASETHC

SECTION X

Food Waste and Other Refuse Materials

1. Food waste, non-edible by-products and other refuse must be:

(a) removed from rooms where food is present as quickly as possible, to avoid their accumulation;

(b) deposited in closable containers of an appropriate construction, kept in sound condition, easy to clean and, where necessary, to disinfect. FABO may use other types of containers or evacuation systems if he can demonstrate to DA-BFAR that they are appropriate.

2. FABO must make adequate provision for the storage and disposal of food waste, non-edible by-products and other refuse. Refuse stores must be designed and managed such that they can be kept clean and, as far as possible, free of animals and pests.

3. All waste must be removed from the site in a hygienic way and must not constitute a direct or indirect source of contamination.

SECTION XI

Personal Hygiene

1. Every person working in a food-handling area must maintain a high degree of personal cleanliness and wear suitable, clean and, where necessary, protective clothing.

2. No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea may handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination.

3. Any person so affected and employed in, or working on the site of, a FA business and who is likely to come into contact with food must immediately report their illness or symptoms, and if possible their causes, to the FABO.

SECTION XII

Training

1. FABO must comply with requirements of Philippine law concerning training programmes for persons working in the FA sector.

2. FABO must ensure that food handlers are instructed and/or trained in food hygiene matters commensurate with their work activity, and appropriately supervised.

3. Staff responsible for preparation, development and maintenance of the relevant HACCP procedures, and for performing control, monitoring and verification of the effectiveness of their implementation and the application of relevant good practice guides must receive adequate and appropriate training covering, but not limited to:

a) application of the basic principles of HACCP;

b) pre-requisite requirements to HACCP such as GAqP, GMP, GHP and SSOP;

c) other relevant subject matter on food safety assurance; and

d) an understanding of relevant national and international legislation on food hygiene and safety.

CHAPTER III

Specific Requirements Concerning Fishery and Aquatic Products

This Chapter does not apply to bivalve molluscs, echinoderms, tunicates and marine gastropods when exported live. IaEASH

However, with the exception of Sections I and II, this Chapter does apply to bivalve molluscs, echinoderms, tunicates and marine gastropods when exported as, or as part of, processed products, in which case they must have been obtained in accordance with Sections II to V, and IX of Chapter IV of this Code of Practice.

This Chapter applies in addition to the general requirements for the construction and operation of establishments, including vessels, set out in Chapters I and II, respectively.

In particular, requirements for food contact materials and surfaces set out in Chapter II apply to all vessels.

SECTION I

Requirements for Vessels

1. Vessels used to harvest fishery products, or to handle or process them after harvesting, must comply with the appropriate structural and equipment requirements.

2. Operations carried out on board vessels must comply with the hygiene requirements listed below.

PART I

Structural and Equipment Requirements for Vessels

A. Requirements for all Vessels

1. Vessels must be designed and constructed to avoid contamination of products with bilge-water, sewage, smoke, fuel, oil, grease or other objectionable substances.

2. The intake for water used with FA products must be located to avoid contamination of the water supply.

B. Requirements for Vessels Intended to Preserve Fresh Products for more than 24 hours

1. Vessels designed and equipped to preserve products for more than 24 hours must be equipped with storage holds, tanks or containers, capable of operating at the temperatures specified in Chapter II, Section VIII, Part A.

2. Storage holds must be separated from the engine compartment and crew quarters by partitions that are sufficient to prevent contamination. Such holds must enable storage of products under satisfactory hygienic conditions and, where necessary, ensure that melt water does not contaminate the product.

3. Where FA products are chilled in cold clean seawater, a uniform temperature throughout the tanks must be achieved at a chilling rate that ensures that the mix of fish and clean seawater reaches not more than 3ºC six hours after loading and not more than 0ºC after 16 hours.

4. Where FA products are chilled in clean ice slurry, tanks must be made of impervious materials, easy to clean and well insulated such that the mix of fish, ice and clean sea water reaches not more than 3ºC six hours after loading and is maintained at 0ºC to 4ºC.

5. In all cases, the temperature must be monitored and, where necessary, recorded. All temperature monitoring equipment must undergo regular annual internal and external calibration.

C. Requirements for Freezer Vessels

1. Freezer vessels must have freezing and/or refrigeration equipment, as appropriate, sufficient to:

(a) lower the temperature rapidly, to achieve a core temperature of -18ºC, or colder. aHSAIT

(b) maintain fishery products at -18ºC, or colder.

2. Storage holds must:

(a) meet the requirements indicated in Part B, points 1 and 2, above.

(b) be equipped with a temperature-recording device in a place where it can be easily read, with the temperature sensor placed in the warmest area of the hold.

3. All temperature monitoring equipment must be subjected to a regular annual internal and external calibration.

D. Requirements for Factory Vessels

1. Factory vessels must have at least:

(a) a receiving area that is reserved for taking FA products on board, easy to clean and designed to protect the products from any source of contamination, the sun or the elements, and to allow each successive catch to be separated;

(b) a hygienic system for conveying FA products from the receiving area to the work area;

(c) work areas that are large enough for the hygienic preparation and processing of FA products, easy to clean and disinfect and designed and arranged in such a way as to prevent any contamination of the products;

(d) hand-washing facility for use by staff engaged in handling exposed FA products, with taps designed to prevent the spread of contamination;

(e) a place for storing packaging materials, separate from product preparation and processing areas;

(f) storage areas for the finished products, large enough and designed to be easy to clean. If a waste-processing unit operates on board, a separate hold must be designated for the storage of such waste;

(g) special equipment for disposing of waste or products that are unfit for human consumption directly into the sea or, where circumstances so require, into a watertight tank reserved for that purpose. If waste is stored and processed on board with a view to its sanitation, separate areas must be allocated for that purpose;

(h) a water intake situated in a position that avoids contamination of the water supply.

2. However, factory vessels on which crustaceans and molluscs are cooked, chilled and wrapped, need not meet the requirements of point 1 if no other form of handling or processing takes place on board.

3. Factory vessels that freeze FA products must have equipment meeting the requirements for freezer vessel laid down in part C, above.

PART II

Hygiene Requirements for Vessels

Fishing vessels must satisfy the basic hygiene requirements laid down in relevant provisions of the Implementing Rules and Regulation of RA 8550 and, where relevant, any additional EU requirements:

1. Parts of vessels or containers set aside for the storage of FA products must be maintained in good condition and kept clean. In particular, they must not be contaminated by fuel or bilge water.

2. As soon as possible after they are taken on board, FA products must be protected from contamination and from the effects of the sun or any other source of heat. Water used for washing must be either potable water or, where appropriate, clean seawater. IEDHAT

3. FA products must be handled and stored so as to prevent bruising. Handlers may use spiked instruments to move large fish or fish which might injure them, provided they do not damage the flesh.

4. FA products other than those kept alive must undergo chilling as soon as possible after loading. However, when this is not possible, they must be landed as soon as possible.

5. Ice used to chill fishery products must be made from potable water or clean seawater. cDHAaT

6. Where fish are headed and/or gutted on board, this must be done hygienically as soon as possible after capture, and the products must be washed immediately and thoroughly with potable water or clean seawater. The viscera and parts that may constitute a danger to public health must be removed and kept apart from products intended for human consumption. Livers and roes intended for human consumption must be preserved under ice, at 0ºC - 4ºC, or be frozen.

7. Where whole fish intended for canning are frozen in brine, a temperature of -9ºC or colder must be achieved for the product. The brine must not be a source of contamination for the fish.

PART III

Requirements During and After Landing

1. Vessel operators responsible for the unloading and landing of FA products in government and or private landing sites must be subject to Official Control by DA-BFAR and must:

(a) ensure that unloading and landing equipment that comes into contact with FA products meets the requirements of Chapter II, Section III, above; and

(b) avoid contamination of FA products during unloading and landing, in particular by:

(i) carrying out unloading and landing operations rapidly;

(ii) placing FA products without delay in a protected environment at the temperature specified in Chapter II, Section VIII, Part A; and

(iii) not using equipment or practices that cause unnecessary damage to edible parts of FA products.

2. FABO responsible for auction and wholesale markets or parts thereof where FA products are displayed for sale must meet the following requirements:

(a) there must be lockable facilities for the refrigerated storage of detained FA products and separate lockable facilities for the storage of products declared unfit for human consumption;

(b) if DA-BFAR so requires, there must be an adequately-equipped lockable facility or, where needed, a room for the exclusive use of DA-BFAR;

(c) at the time of display or storage of FA products:

(i) the premises must not be used for other purposes;

(ii) vehicles emitting exhaust fumes likely to impair the quality of fishery products must not have access to the premises;

(iii) persons having access to the premises must not introduce other animals; and

(iv) the premises must be well lit to facilitate Official Controls. cSIACD

3. When chilling was not possible on board the vessel, fresh fishery products, other than those kept alive, must undergo chilling as soon as possible after landing and be stored between 0ºC to 4ºC.

SECTION II

Requirements for Establishments and Vessels Handling FA Products

FABO must ensure that the construction, maintenance and operation of all premises, and the conduct and management of all personnel, comply with the requirements of Chapters I and II, as appropriate.

FABO must also comply with the following additional requirements, where relevant, in establishments handling FA products.

PART I

Requirements for Fresh FA Products

1. Unpackaged, chilled products that are not dispatched, prepared or processed immediately after landing or delivery must be stored under ice in appropriate facilities and re-iced as often as necessary.

2. Packaged fresh fishery products must be chilled to, and maintained between 0º to 4ºC.

3. Operations such as heading and gutting must be carried out hygienically. Gutting, when technically and commercially feasible, must be carried out as soon as possible after catching or landing. The products must be washed thoroughly and immediately with potable water or, on board vessels, clean seawater.

4. Operations such as filleting and cutting must be carried out so as to avoid contamination or spoilage. Fillets and slices must not remain on working tables for longer than necessary for their preparation; they must be wrapped and, where necessary, packaged and chilled as soon as possible after preparation.

5. Containers used for the dispatch or storage of unpackaged, prepared fresh FA products stored under ice must ensure that melt water does not contaminate the products.

6. Whole and gutted fresh products may be transported and stored in cooled water on board vessels. They may also continue to be transported in cooled water after landing, until they arrive at the first establishment on land for further processing.

PART II

Requirements for Frozen Products

1. Establishments on land that freeze FA products must have freezing or refrigeration equipment, as appropriate, with sufficient capacity to:

(a) lower the temperature of the products rapidly to achieve a core temperature of -18ºC or colder;

(b) maintain the FA products at -18ºC or colder.

2. Storage areas must be equipped with a temperature-recording device in a place where it can be easily read, with the temperature sensor situated in the warmest part of the storage area.

3. All temperature monitoring equipment must be subjected to a regular annual internal and external calibration.

PART III

Requirements for Mechanically Separated Fishery Products

FABO manufacturing mechanically separated products must comply with the following requirements.

1. Raw materials:

(a) only whole fish and bones obtained from filleting may be used; ISHaCD

(b) all raw materials must be free from intestinal material.

2. Manufacturing process:

(a) mechanical separation must take place without undue delay after filleting;

(b) if whole fish are used, they must be gutted and washed beforehand;

(c) after production, mechanically separated fishery products must be frozen as quickly as possible or incorporated in a product intended for freezing or subjected to a stabilising treatment.

PART IV

Requirements Concerning Parasites

For the purposes of this Part:

'Candling' means, in respect of flat fish or fish fillets, holding up fish to a light in a darkened room to detect parasites.

'Visible parasite' means a parasite or a group of parasites of a size, colour or texture that is clearly distinguishable from fish tissues.

'Visual inspection' means non-destructive examination of fish or FA products, with or without optical magnification and under good light conditions for human vision including, if necessary, candling.

1. FA products which are obviously infested with parasites must not be released for export to the EU.

2. FABO must carry out checks at all stages during the production and handling of FA products on shore and on board vessels to detect parasites in fish and FA products.

3. Visual inspection must be performed on a representative number of samples by suitably-qualified persons, who must also determine the scale and frequency of the inspections by reference to the type of fishery products, their geographical origin and their use. During production, visual inspection of eviscerated fish must be carried out on the abdominal cavity and livers and roes intended for export.

Visual inspection must be carried out:

(a) in the case of manual evisceration, in a continuous manner by the handler at the time of evisceration and washing;

(b) in the case of mechanical evisceration, by sampling carried out on a representative number of samples, being not less than 10 fish per batch. aDATHC

Visual inspection of fillets or slices must be carried out during trimming and after filleting or slicing. Where an individual examination is not possible because of the size of the fillets or the filleting operations, a sampling plan must be drawn up and kept available for DA-BFAR. Where candling of fillets is necessary from a technical viewpoint, it must be included in the sampling plan.

4. The following products must be frozen at a core temperature of -18ºC for not less than 24 hours; this treatment must be applied to either raw or finished product:

(a) products to be consumed raw or almost raw;

(b) products such as herring, round scad, mackerel and tuna that are to undergo a cold smoking process in which the internal temperature of the fishery product will not reach more than 60ºC;

(c) marinated and/or salted products, if the processing is insufficient to destroy nematode larvae. AcSIDE

5. FABO need not carry out the treatment required under point 4 if:

(a) epidemiological data indicates that the grounds where the fish were caught do not present a health hazard with regard to the presence of parasites; and

(b) DA-BFAR so authorizes.

6. A document from the manufacturer, stating the type of process they have undergone, must accompany products referred to in point 4 when exported to the EU.

PART V

Requirements for Fish Oil for Human Consumption

FABO must ensure that raw materials used in the preparation of fish oil for human consumption are:

(a) obtained from fishery products that are fit for human consumption;

(b) from establishments, including vessels, meeting the requirements of this Order and approved by DA-BFAR in accordance with FAO No. 228, Series 2008, ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption);

(c) transported and stored until processing in hygienic conditions.

PART VI

Requirements for Processed FA Products

FABO cooking crustaceans and molluscs must comply with the following requirements:

1. Cooked products must be rapidly cooled immediately after cooking, using potable water or, on board vessels, clean water. If no preservation other than chilling is used, cooling must continue until the product reaches between 0ºC - 4ºC.

2. Shelling or shucking must be carried out hygienically, avoiding contamination of the product. Where such operations are done by hand, workers must pay particular attention to washing their hands.

3. After shelling or shucking, cooked products must be frozen or chilled as soon as possible to the temperatures laid down in Chapter II, Section VIII, Part A.

PART VII

Health Standards for FA Products

In addition to meeting the hygiene requirements of this Code of Practice, FABO must ensure that FA products meet the appropriate health standards below. In all cases, the criteria are based on sampling plans carried out in accordance with ACMSF principles.

FABO must also ensure that Live Bivalve Molluscs meet the additional and specific criteria set out in Chapter IV, Section V.

In the case of dried, processed or multi-ingredient products, changes to the concentration of the contaminant caused by the drying, processing and/or mixing, and the analytical limit of quantification must be taken into account. Specific concentration/dilution factors for the processes and products concerned must be provided and justified by FABO, when DA-BFAR carries out an Official Control. If FABO does not provide the necessary concentration or dilution factor or if DA-BFAR deems the factor inappropriate, DA-BFAR must itself define that factor.

Further detailed methodology and explanatory footnotes are present in the EU legislation 1 and should be consulted in specific cases. ISAcHD

A. Organoleptic Properties of Fishery Products

FABO must carry out an organoleptic examination of FA products to ensure, in particular, that they meet the required freshness criteria.

B. Histamine

FABO must ensure that specified EU limits are not exceeded for products from species associated with a high level of histamine, particularly those of the families: Scombridae, Clupeidae, Engraulidae, Coryfenidae, Carangidae, Pomatomidae, Scombresosidae:

(i) when subjected to enzyme maturation in brine: m = 200 mg/kg; M = 400 mg/kg

(ii) all other cases: m = 100 mg/kg; M = 200 mg/kg

in each case, based on an ACMSF sampling plan: n = 9; c = 2.

These limits apply throughout the life of the product; FABO should therefore allow a suitable margin at the time of export.

C. Total Volatile Nitrogen

Unprocessed FA products must not be exported if organoleptic assessment has raised doubts as to their freshness and chemical checks reveal that the following TVB-N limits are exceeded, (expressed as mg of nitrogen per 100g flesh):

(i) Sebastes spp., Helicolenus dactylopterus, Sebastichthys capensis: 25 mg

(ii) Pleuronectidae family (with the exception of halibut: Hippoglossus spp.): 30 mg

(iii) Salmo salar, species belonging to the Merlucciidae family, species belonging to the Gadidae family: 35 mg

The methods to be used by DA-BFAR to check compliance with these limits and, where appropriate, by FABO, are defined in Chapter X of "The Code of Good Practice for the Organisation and Implementation of Official Controls for the Export of FA Products to the EU, 2008".

D. Toxins Harmful to Human Health

1. Products derived from poisonous fish of the following families must not be exported to the EU market: Tetraodontidae, Molidae, Diodontidae and Canthigasteridae. HDIATS

2. Fresh, prepared and processed FA products belonging to the family Gempylidae, in particular Ruvettus pretiosus and Lepidocybium flavobrunneum, intended for the EU market must be wrapped and/or packaged and must be labelled with appropriate consumer information on preparation/cooking methods and the risk related to the presence of substances with adverse gastrointestinal effects. The scientific name must accompany the common name on the label. EaCSTc

3. Fishery products containing biotoxins such as ciguatoxin or muscle-paralysing toxins must not be placed on the EU market.

4. However, live bivalve molluscs, echinoderms, tunicates and marine gastropods may be placed on the EU market if they have been produced in accordance with this Order and FAO No. 228, Series of 2008, ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption"), and their implementing Codes of Practice. They must, in particular, meet the criteria set in Chapter IV, Section V.3 of this Code.

The methods to be used by DA-BFAR to check compliance with the limits laid down in Chapter IV, Section V.3 of this Code of Practice and, where appropriate, by FABO, are defined in Chapter XI of "The Code of Good Practice for the Organisation and Implementation of Official Controls for the Export of FA Products to the EU, 2008". CcaASE

E. Microbiological Criteria

FA products must meet the following EU microbiological criteria: 2

(i) Cooked crustaceans and molluscs:

 Salmonella: absent in 25g, based on n = 5; c = 0

(ii) Shelled and shucked products of cooked crustaceans and molluscan shellfish must also meet the following indicators of GHP:

 E.coli: m = 1 cfu/g, M = 10 cfu/g, based on n = 5 c = 2 (ISO TS 16649-3)

 Coagulase-positive staphylococci: m = 100 cfu/g, M = 1,000 cfu/g, based on n = 5 c = 2; (EN/ISO 6888-1 or -2)

 Sampling must be carried out at the end of the manufacturing process. Where the prescribed standard is not met, FABO must make the necessary improvements to production hygiene.

F. Heavy Metals

FA products must meet the following EU criteria for Heavy Metal contaminants; all values are expressed as mg/kg (ppm) wet weight:

(i) Lead

 Muscle meat of fish: 0.3 mg/kg

 Crustaceans, excluding brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae): 0.5 mg/kg

 Bivalve molluscs: 1.5 mg/kg

 Cephalopods (without viscera): 1.0 mg/kg

(ii) Cadmium

 Muscle meat of fish, excluding species listed below: 0.05 mg/kg

 Muscle meat of the following fish: 0.1 mg/kg

 Anchovy (Engraulis species); Bonito (Sarda sarda); Common two-banded Sea Bream (Diplodus vulgaris); Eel (Anguilla anguilla); Grey Mullet (Mugil labrosus labrosus); Horse Mackerel or Scad (Trachurus species); Louvar or Luvar (Luvarus imperialis); Sardine (Sardina pilchardus); Sardinops (Sardinops species); Tuna (Thunnus species, Euthynnus species, Katsuwonus pelamis); Wedge Sole (Dicologoglossa cuneata);

 Muscle meat of swordfish (Xiphias gladius): 0.3 mg/kg

 Crustaceans, excluding brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae): 0.5 mg/kg

 Bivalve molluscs: 1.0 mg/kg

 Cephalopods (without viscera): 1.0 mg/kg

(iii) Mercury

 Fishery products and muscle meat of fish, excluding species listed below: 0.5 mg/kg

 Crustaceans, excluding the brown meat of crab, and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae): 0.5 mg/kg

 Muscle meat of the following: 1.0 mg/kg HEDaTA

 Anglerfish (Lophius species); Atlantic Catfish (Anarhichas lupus); Bonito (Sarda sarda); Eel (Anguilla species); Emperor, Orange Roughy, Rosy Soldierfish (Hoplostethus species); Grenadier (Coryphaenoides rupestris); Halibut (Hippoglossus hippoglossus); Marlin (Makaira species); Megrim (Lepidorhombus species); Mullet (Mullus species); Pike (Esox lucius); Plain Bonito (Orcynopsis unicolor); Poor Cod (Tricopterus minutes); Portuguese Dogfish (Centroscymnus coelolepis); Rays (Raja species); Redfish (Sebastes marinus, S. mentella, S. viviparus); Sail Fish (Istiophorus platypterus); Scabbard fish (Lepidopus caudatus, Aphanopus carbo); Sea Bream, pandora (Pagellus species); Shark (all species); Snake Mackerel or Butterfish (Lepidocybium flavobrunneum, Ruvettus pretiosus, Gempylus serpens); Sturgeon (Acipenser species); Swordfish (Xiphias gladius); Tuna (Thunnus species, Euthynnus species, Katsuwonus pelamis)

(iv) Tin (inorganic)

 All canned foods: 200 mg/kg

G. Dioxins

FA products must meet the following EU criteria for Dioxins and dioxin-like PCBs contaminants; all values are expressed as pg/g wet weight (except for fish oil products):

 Sum of dioxins is expressed as WHO-PCDD/F-TEQ

 Sum of dioxins and dioxin-like PCBs is expressed as WHO-PCDD/F-PCB-TEQ

(i) Muscle meat of fish and fishery products and products thereof, excluding eel:

 Dioxins: 4 pg/g

 Dioxins and dioxin-like PCBs: 8 pg/g

(ii) Crustaceans, excluding the brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae):

 Dioxins: 4 pg/g

 Dioxins and dioxin-like PCBs: 8 pg/g

(iii) Muscle meat of eel (Anguilla anguilla) and products thereof

 Dioxins: 4 pg/g

 Dioxins and dioxin-like PCBs: 12 pg/g

(iv) Fish oils (fish body oil, fish liver oil and oils of other marine species for human consumption):

 Dioxins: 2 pg/g fat

 Dioxins and dioxin-like PCBs: 10 pg/g fat

H. Benzo(a)pyrene

FA products must meet the following EU criteria for Benzo(a)pyrene; all values are expressed as µg/kg wet weight. Where the maximum is expressed on the basis of muscle meat, but the fish is to be eaten whole, the value is applied to the whole fish. HSTAcI

(i) Muscle meat of smoked fish and smoked FA products, excluding bivalve molluscs: 5.0 µg/kg

(ii) Smoked crustaceans, excluding the brown meat of crab, and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae): 5.0 µg/kg

(iii) Muscle meat of fish (24) (25), other than smoked fish: 2.0 µg/kg

(iv) Crustaceans, cephalopods, other than smoked; in the case of Crustaceans, excluding the brown meat of crab and excluding head and thorax meat of lobster and similar large crustaceans (Nephropidae and Palinuridae): 5.0 µg/kg caHIAS

(v) Bivalve molluscs: 10.0 µg/kg

(vi) Fish Oils for direct human consumption or use as an ingredient: 2.0 µg/kg

CHAPTER IV

Specific Requirements for Live Bivalve Molluscs for Export

Scope

This Chapter applies to live bivalve molluscs. With the exception of the provisions on purification, it also applies to live echinoderms, tunicates and marine gastropods.

Sections I to VIII apply to animals harvested from production areas that the DA-BFAR has classified in accordance with FAO No. 228, Series of 2008, ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption), and its implementing Code of Practice.

Section IX applies to Pectinidae harvested outside the classified areas.

Sections V, VI, VIII and IX, and Section VII, point 3, will apply at the point of retail sale within the EU.

The requirements of this Chapter supplement those laid down in Chapters I and II above:

(a) In the case of operations that take place before live bivalve molluscs arrive at a dispatch or purification centre, they supplement the requirements of Chapter I;

(b) In the case of other operations, they supplement the requirements of Chapter II.

Definitions

For the purpose of this Chapter, the terms and phrases defined below apply and have legal effect as if they were integral to FAO No. 228, Series of 2008:

Conditioning — the storage of live bivalve molluscs coming from class A production areas, purification centres or dispatch centres in tanks or any other installation containing clean seawater, or in natural sites, to remove sand, mud or slime, to preserve or to improve organoleptic qualities and to ensure that they are in a good state of vitality before wrapping or packaging.

Dispatch centre — any on-shore or off-shore establishment for the reception, conditioning, washing, cleaning, grading, wrapping and packaging of live bivalve molluscs fit for human consumption.

Gatherer — any natural or legal person who collects live bivalve molluscs by any means from a harvesting area for the purpose of handling and placing on the market. TAScID

Live bivalve molluscs — unless otherwise stated, includes live echinoderms, tunicates and marine gastropods.

Marine biotoxins — poisonous substances accumulated by bivalve molluscs, in particular, as a result of feeding on plankton containing toxins.

Pectinidae — member of a family of over 30 genera of bivalves, which may swim by expelling water from their shell in a series of snapping motions (such as the genus Aequipecten and Pecten, e.g., scallops) or may be attached to a substrate (such as Chlamys).

Production area — any sea, estuarine or lagoon area, containing either natural beds of bivalve molluscs or sites used for the cultivation of bivalve molluscs, and from which live bivalve molluscs are taken. SIDEaA

Purification centre — an establishment with tanks fed by clean seawater in which live bivalve molluscs are placed for the time necessary to reduce contamination to make them fit for human consumption.

Relaying — the transfer of live bivalve molluscs to sea, lagoon or estuarine areas for the time necessary to reduce contamination to make them fit for human consumption. This does not include the specific operation of transferring bivalve molluscs to areas more suitable for further growth or fattening.

Relaying area — any sea, estuarine or lagoon area with boundaries clearly marked and indicated by buoys, posts or any other fixed means, and used exclusively for the natural purification of live bivalve molluscs.

Self-cleaning — soaking live shellfish in clean seawater for 12 hours or more to remove dirt, mud and sand.

SECTION I

General Requirements

1. Live bivalve molluscs may not be exported other than via a dispatch centre, where an identification mark must be applied in accordance with Article 7 and Chapter V.

2. FABO may accept batches of live bivalve molluscs only if the documentary requirements set out in points 3 to 7 have been met.

3. Whenever a FABO moves a batch of live bivalve molluscs between establishments, up to and including the arrival of the batch at a dispatch centre or processing establishment, a registration document must accompany the batch.

4. When products are exported to the EU, the registration document must be in at least one official language of the EU Member State to which the product will be exported and contain at least the information specified below:

(a) in the case of a batch of live bivalve molluscs sent from a production area, the registration document must contain at least the following:

(i) gatherer's identity and address;

(ii) date of harvesting;

(iii) location of production area described in as precise detail as practicable, or by a code number;

(iv) health status of the production area;

(v) shellfish species and quantity; and

(vi) destination of the batch;

(b) in the case of a batch of live bivalve molluscs sent from a relaying area, the registration document must contain at least the information referred to in paragraph 4(a)(i) and the following:

(i) location of the relaying area; and

(ii) duration of relaying;

(c) in the case of a batch of live bivalve molluscs sent from a purification centre, the registration document must contain at least the information referred to in paragraph 4(a) and the following:

(i) address of the purification centre;

(ii) duration of purification; and cSATEH

(iii) dates on which the batch entered and left the purification centre.

5. FABO sending batches of live bivalve molluscs must complete the relevant sections of the registration document so that they are easy to read and cannot be altered. FABO receiving batches must either date-stamp the document on receipt of the batch or record the date in an alternative manner.

6. FABO must keep a copy of the registration document relating to each batch sent and received for at least twelve months after its dispatch or receipt (or such longer period as DA-BFAR may specify).

7. However, registration documents are not necessary if:

(a) the staff gathering live bivalve molluscs also operate the dispatch centre, purification centre, relaying area or processing establishment receiving the live bivalve molluscs;

 

(b) only DA-BFAR supervises all the establishments concerned; and

(c) DA-BFAR so permits.

SECTION II

Hygiene Requirements for Production and Harvesting

The requirements in this Section must apply without prejudice to the general requirements of Republic Act No. 8550, Philippine Fisheries Code of 1998, and Fisheries Administrative Order No. 209, Series of 2001 (Guideline on the Production, Harvesting, Handling and Transportation of Shellfish for Implementation of the Local Government), as applied to the harvesting, production, preparation and processing of live bivalve molluscs for domestic or non-EU markets.

PART A

Requirements for Production Areas

1. Gatherers may only harvest live bivalve molluscs from production areas with fixed locations and boundaries that DA-BFAR has classified, where appropriate in cooperation with FABO, as being of class A, B or C in accordance with the FAO No. 228, Series of 2008, ("Rules for the organization of Official Controls on FA products intended for export to the EU for human consumption), and its implementing Code of Practice. CSTDIE

2. FABO may export live bivalve molluscs collected from Class A production areas only if they meet the health requirements of Section V.

3. FABO may export live bivalve molluscs collected from Class B production areas only after treatment in a purification centre, or after relaying, in all cases in accordance with the relevant provisions of this Chapter.

4. FABO may export live bivalve molluscs collected from Class C production areas only after relaying over a long period in accordance with Part C of this Section.

5. After purification or relaying, live bivalve molluscs from Class B or C production areas must meet all of the requirements of Section V. However, live bivalve molluscs from such areas that have not been submitted for purification or relaying may be sent to a processing establishment, where they must undergo treatment to eliminate pathogenic micro-organisms (where appropriate, after removal of sand, mud or slime in the same or another establishment).

The permitted treatment methods are:

(a) sterilisation in hermetically sealed containers; and

(b) heat treatments involving: ATcaEH

(i) immersion in boiling water for the period required to raise the internal temperature of the mollusc flesh to not less than 90ºC and holding at this temperature for not less than 90 seconds;

(ii) cooking for three to five minutes in an enclosed space where the temperature is between 120ºC and 160ºC and the pressure is between 2 and 5 kg/cm2, followed by shelling and freezing of the flesh to a core temperature of -20ºC; and

(iii) steaming under pressure in an enclosed space satisfying the requirements relating to cooking time and the internal temperature of the mollusc flesh mentioned under (i). Validated methodology must be used; procedures based on the HACCP principles must be in place to verify the uniform distribution of heat. CSTDIE

6. FABO must not export live bivalve molluscs from areas that DA-BFAR has not classified, or which are unsuitable for health reasons. FABO must take account of any relevant information concerning the suitability of an area for production and harvesting, including information obtained from own-checks and DA-BFAR, and must use this information, particularly that related to environmental and weather conditions, to determine the appropriate treatment to apply to harvested batches.

PART B

Requirements for Harvesting and Handling

FABO harvesting live bivalve molluscs, or handling them immediately after harvesting, must comply with the following requirements:

1. Harvesting techniques and further handling must not cause additional contamination or excessive damage to the shells or tissues of the live bivalve molluscs or result in changes significantly affecting their suitability for treatment by purification, processing or relaying. FABO must in particular:

(a) adequately protect live bivalve molluscs from crushing, abrasion or vibration;

(b) not expose live bivalve molluscs to extreme temperatures;

(c) not re-immerse live bivalve molluscs in water that could cause additional contamination; and

(d) if carrying out conditioning in natural sites, use only areas classified by DA-BFAR as Class A.

2. Means of transport must permit adequate drainage, be equipped to ensure the best survival conditions possible and provide efficient protection against contamination.

PART C

Requirements for Relaying Live Bivalve Molluscs

FABO relaying live bivalve molluscs must comply with the following requirements:

1. FABO may use only those areas that DA-BFAR has approved for relaying live bivalve molluscs. Buoys, poles or other fixed means must clearly identify the boundaries of the sites. There must be a minimum distance between relaying areas, and also between relaying areas and production areas, so as to minimise any risk of the spread of contamination.

2. Conditions for relaying must ensure optimal conditions for purification. In particular, FABO must: TAHCEc

(a) use techniques for handling live bivalve molluscs intended for relaying that permit the resumption of filter-feeding activity after immersion in natural waters;

(b) immerse live bivalve molluscs in seawater at the relaying area for an appropriate period, fixed depending on the water temperature; this period must be at least two months unless DA-BFAR agrees to a shorter period on the basis of the FABO's risk analysis;

(c) ensure sufficient separation of sites within a relaying area to prevent mixing of batches; the 'all in, all out' system must be used, so that a new batch cannot be brought in before the whole of the previous batch has been removed; and

(d) not relay live bivalve molluscs at a density that prevents purification.

3. FABO managing relaying areas must keep permanent records of the source of live bivalve molluscs, relaying periods, relaying areas used and the subsequent destination of the batch after relaying, for inspection by DA-BFAR.

SECTION III

Structural Requirements for Purification and Dispatch Centres

1. The location of premises on land must not be subject to flooding by ordinary high tides or run-off from surrounding areas.

2. Tanks and water storage containers must:

(a) have smooth, durable, impermeable and easy to clean internal surfaces;

(b) be constructed to allow complete draining of water;

(c) have any water intake situated in a position that avoids contamination of the water supply.

3. In addition, in purification centres, purification tanks must be suitable for the volume and type of products to be purified.

SECTION IV

Hygiene Requirements for Purification and Dispatch Centres

PART A

Requirements for Purification Centres

FABO purifying live bivalve molluscs must comply with the following requirements: IDEHCa

1. Before purification commences, live bivalve molluscs must be washed free of mud and accumulated debris, using clean water.

2. Operation of the purification system must allow live bivalve molluscs rapidly to resume and to maintain filter-feeding activity, to eliminate sewage contamination, not to become re-contaminated and to be able to remain alive in a suitable condition after purification for wrapping, storage and transport.

3. The quantity of live bivalve molluscs to be purified must not exceed the capacity of the purification centre. They must be continuously purified for a period sufficient for them to meet the health standards set out in Section V.

4. If a purification tank contains several batches of live bivalve molluscs, they must be of the same species and the length of the treatment must be based on the time required by the batch needing the longest period of purification. HCIaDT

5. Containers used to hold live bivalve molluscs in purification systems must be constructed to allow clean seawater to flow through. The depth of layers of live bivalve molluscs must not impede the opening of shells during purification.

6. No crustaceans, fish or other marine species may be kept in a purification tank in which live bivalve molluscs are undergoing purification.

7. Every package containing purified live bivalve molluscs sent to a dispatch centre must be provided with a label certifying that all molluscs have been purified.

PART B

Requirements for Dispatch Centres

FABO operating dispatch centres must comply with the following requirements:

1. Handling of live bivalve molluscs, particularly conditioning, calibration, wrapping and packing, must not contaminate the product or affect the viability of the molluscs. aSIAHC

2. Before dispatch, the shells of live bivalve molluscs must be washed thoroughly with clean water.

3. Live bivalve molluscs must come from:

(a) a class A production area;

(b) a relaying area;

(c) a purification centre; or

(d) another dispatch centre.

4. Points 1, 2, and 3 (a) and (b) also apply to dispatch centres situated on board vessels and the molluscs handled therein.

SECTION V

Health Standards

FABO must ensure that exported live bivalve molluscs meet the following standards:

1. They have organoleptic characteristics associated with freshness and viability, including shells free of dirt, an adequate response to percussion and normal amounts of intra-valvular liquid.

2. They must meet EU microbiological criteria: TAHcCI

 Salmonella: absent in 25g, based on n = 5; c = 0

 E. coli: 230 MPN/100g of flesh and intra-valvular liquid, based on n = 1; c = 0

3. They must not contain marine biotoxins in total quantities (measured in the whole body or any part edible separately) that exceed the following:

(a) paralytic shellfish poison (PSP): 800 micrograms per kilogram (µg/kg);

(b) amnesic shellfish poison (ASP): 20 milligrams of domoic acid per kilogram (mg/kg);

(c) okadaic acid, dinophysistoxins and pectenotoxins together: 160 micrograms of okadaic acid equivalents per kilogram (µg/kg);

(d) yessotoxins: 1 milligram of yessotoxin equivalent per kilogram (mg/kg); and

(e) azaspiracids: 160 micrograms of azaspiracid equivalents per kilogram (µg/kg).

The methods to be used by DA-BFAR to check compliance with specified limits and, where appropriate, by FABO, are defined in Chapter XI of "The Code of Good Practice for the Organisation and Implementation of Official Controls for the Export of Fish and Aquatic Products from the Philippines to the EU, 2008". cTADCH

SECTION VI

Wrapping and Packaging

1. Oysters must be wrapped or packaged with the concave shell downwards.

2. Individual consumer-size packages of live bivalve molluscs must be closed and remain closed after leaving the dispatch centre.

SECTION VII

Identification Marking and Labelling

1. The label, including the identification mark, must be waterproof.

2. In addition to the general requirements for identification marks contained in Chapter V, the following information must be shown on the label:

(a) species of bivalve mollusc (common name and scientific name);

(b) date of packaging, comprising at least the day and the month; and

(c) date of minimum durability.

3. However, the date of minimum durability may be replaced by the statement "these animals must be alive when sold".

SECTION VIII

Other Requirements

1. FABO storing, transporting and exporting live bivalve molluscs must ensure that the products are kept at a temperature that does not adversely affect food safety or their viability.

2. Live bivalve molluscs must not be re-immersed in, or sprayed with, water after they have been packaged and left the dispatch centre.

SECTION IX

Specific Requirements for Pectinidae Harvested Outside Classified Production Areas

FABO harvesting Pectinidae outside classified production areas or handling such Pectinidae must comply with the following requirements:

1. Pectinidae intended for export must be harvested and handled in accordance with Section II, Part B, and meet the standards laid down in Section V, as verified by FABO own-checks.

2. In addition, where data from official monitoring programmes enable DA-BFAR to classify fishing grounds — where appropriate, in cooperation with FABO — the provisions of Section II, Part A, apply by analogy to Pectinidae. HCTDIS

3. Pectinidae may not be exported unless FABO can show traceability through an auction, dispatch centre or processing establishment, as appropriate.

4. FABO handling Pectinidae must comply:

(a) with the documentation requirements of Section I, points 3 to 7, where applicable. The registration document must clearly indicate the location of the area where the Pectinidae were harvested; or ISDHEa

(b) when Pectinidae are packaged, or when wrapped if this provides protection equivalent to that of packaging, with the identification marking and labelling requirements of Section VII.

CHAPTER V

Identification Marking

FABO must ensure that FA products intended for export to the EU have an Identification Mark ("Mark") applied in accordance with the following provisions, and those of FAO No. 228 Series of 2008, "Rules governing the organization and implementation of official controls on fishery and aquatic products intended for export to the EU market for human consumption" and its Implementing Code of Practice.

1. Application of the Mark

(a) the mark must be applied before the product leaves the establishment;

(b) however, if packaging and/or wrapping is removed, or the product is further processed in another establishment, a new mark must be applied to indicate the approval number of the second establishment where these operations take place.

2. Form of the Mark

(a) the mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed to facilitate control procedures by Competent Authorities;

(b) the mark must indicate:

(i) the approval number of the establishment;

(ii) the origin as the Philippines, which may appear in full or abbreviated to PH, in accordance with ISO standard 3166-1-alpha-2 code elements.

3. Method of Marking

(a) the mark may be applied directly to, or be printed on a label fixed to, the product, the wrapping or the packaging. It may also be an irremovable tag made of a resistant material; HSEcTC

(b) when the mark is printed on the packaging or applied to a label fixed on the packaging, it must be done such that the mark is destroyed when the packaging is opened, except when the process of opening destroys the packaging. When wrapping provides the same protection as packaging, the mark may be affixed to the wrapping;

(c) when FA products are placed in transport containers or large packages and are intended for further handling, processing, wrapping or packaging in another establishment, the mark may be applied to the external surface of the container or packaging;

(d) when FA products are carried in bulk, a mark is not necessary if accompanying documentation contains the information specified in point 2(b);

(e) when FA products are placed in a package destined for direct supply to the final consumer, the mark may be applied to the exterior of that package only. DEICTS

CHAPTER VI

Food and Agriculture Organisation Fishery Catch Areas

Catch area	Identification of the area (1)
North-West Atlantic	FAO area 21
North-East Atlantic (2)	FAO area 27
Baltic Sea	FAO area 27.IIId
Central-Western Atlantic	FAO area 31
Central-Eastern Atlantic	FAO area 34
South-West Atlantic	FAO area 41
South-East Atlantic	FAO area 47
Mediterranean Sea	FAO areas 37.1, 37.2 and 37.3
Black Sea	FAO area 37.4
Indian Ocean	FAO areas 51 and 57
Pacific Ocean	FAO areas 61, 67, 71, 77, 81 and 87
Antarctic	FAO areas 48, 58 and 88

 

(1) FAO yearbook. Fishery statistics. Catches. Vol. 86/1. 2000.

(2) Excluding the Baltic Sea.

CHAPTER VII

EU Standards for Potable Water

	Microbiological parameters
	Parameter		Parametric value
			(number/100 ml)
Escherichia coli (E. coli)			0
Enterococci			0
	Chemical parameters
Parameter	Parametric	Unit	Notes
	value
Acrylamide	0.1	µg/l	Note 1
Antimony	5	µg/l
Arsenic	10	µg/l
Benzene	1	µg/l
Benzo(a)pyrene	0.01	µg/l
Boron	1	mg/l
Bromate	10	µg/l	Note 2
Cadmium	5	µg/l
Chromium	50	µg/l
Copper	2	mg/l	Note 3
Cyanide	50	µg/l
1,2-dichloroethane	3	µg/l
Epichlorohydrin	0.1	µg/l	Note 1
Fluoride	1.5	mg/l
Lead	10	µg/l	Notes 3 and 4
Mercury	1	µg/l
Nickel	20	µg/l	Note 3
Nitrate	50	mg/l	Note 5
Nitrite	0.5	mg/l	Note 5
Pesticides	0.1	µg/l	Notes 6 and 7
Pesticides — Total	0.5	µg/l	Notes 6 and 8
Polycyclic aromatic	0.1	µg/l	Sum of concentrations of
hydrocarbons			specified compounds; Note 9
Selenium	10	µg/l
Tetrachloroethene and	10	µg/l	Sum of concentrations of
Trichloroethene			specified parameters
Trihalomethanes — Total	100	µg/l	Sum of concentrations of
			specified compounds; Note 10
Vinyl chloride	0.5	µg/l	Note 1

 

Note 1: The value refers to the residual monomer concentration in the water as calculated according to specifications of the maximum release from the corresponding polymer in contact with the water.

Note 2: Where possible, without compromising disinfection, a lower value should be sought. Between 2003 and 2008 the level is 25 µg/l; thereafter, the level is 10 µg/l.

Note 3: The value applies to a sample of water intended for human consumption, obtained by an adequate sampling method at the tap and taken so as to be representative of a weekly average value ingested by consumers.

Note 4: Between 2003 and 2013, the value is 25 µg/l; thereafter, the value will be 10 µg/l.

Note 5: The total level of [nitrate (mg/l) ÷ 50] + [nitrite (mg/l) ÷ 3] must be < 1; the level of nitrites, ex water treatment works, must not exceed 0.10 mg/l.

Note 6:

'Pesticides' means:

o organic insecticides,

o organic herbicides,

o organic fungicides,

o organic nematocides,

o organic acaricides,

o organic algicides,

o organic rodenticides

o organic slimicides,

o related products (inter alia, growth regulators)

and their relevant metabolites, degradation and reaction products.

However, only those pesticides which are likely to be present in a given supply need be monitored. CaHcET

Note 7: The value applies to each individual pesticide. In the case of aldrin, dieldrin, heptachlor and heptachlor epoxide the value is 0.03 µg/l.

Note 8: 'Pesticides — Total' means the sum of all individual pesticides detected and quantified in the monitoring procedure.

Note 9: The specified compounds are:

o benzo(b)fluoranthene,

o benzo(k)fluoranthene,

o benzo(ghi)perylene,

o indeno(1,2,3-cd)pyrene.

Note 10: Where possible, without compromising disinfection, lower values should be sought. The specified compounds are: chloroform, bromoform, dibromochloromethane, bromodichloromethane. The level for total THMs until the end of 2008 is 150. Thereafter, it will be 100 µg/l. ACTIcS

CHAPTER VIII

EU Member States and Territories

1. Provisions of this Order apply to products destined for export to the following territories of Member Countries of the European Community:

Republic of Austria

Kingdom of Belgium

Republic of Bulgaria

Republic of Cyprus

Czech Republic

Kingdom of Denmark with the exception of the Faroe Islands and Greenland

Republic of Estonia

Republic of Finland

French Republic

Federal Republic of Germany

Hellenic Republic

Republic of Hungary

Ireland

Italian Republic

Republic of Latvia

Republic of Lithuania

Grand Duchy of Luxembourg

Republic of Malta

Kingdom of the Netherlands in Europe

Republic of Poland

Portuguese Republic

Romania

Slovak Republic

Republic of Slovenia

Kingdom of Spain with the exception of Ceuta and Melilla

Kingdom of Sweden

United Kingdom of Great Britain and Northern Ireland

2. The provisions of this Order do not apply to the Overseas Countries and Territories of the EU Member States listed above:

Greenland

New Caledonia and Dependencies

French Polynesia

French Southern and Antarctic Territories

Wallis and Futuna Islands

Mayotte

Saint Pierre and Miquelon

Aruba

Netherlands Antilles:

— Bonaire

— Curaçao

— Saba

— Sint Eustatius

— Sint Maarten

Anguilla

Cayman Islands

Falkland Islands

South Georgia and the South Sandwich Islands

Montserrat

Pitcairn

Saint Helena and Dependencies

British Antarctic Territory

British Indian Ocean Territory

 

Turks and Caicos Islands EaHIDC

British Virgin Islands

Bermuda

 

Footnotes

1. Regulation 1881/2006 setting maximum levels for certain contaminants in foodstuffs: OJ L 364 p. 5 20.12.2006.

2. Regulation (EC) No. 2073/2005 of 15 Nov. 2005 on microbiological criteria for foodstuffs: OJ L 338, p. 1; 22 Dec. 2005.

Published in The Philippine Star on June 24, 2009.

n Note from the Publisher: Copied verbatim from the official copy. Duplication of letter (c).

n Note from the Publisher: Copied verbatim from the official copy. Duplication of paragraph (ii).