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

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;

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.

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:

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 2 11, 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 Organization 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.

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 recognized 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 recognized 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 authorized 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;

(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).

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.

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”).

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 Organization 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.

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;

(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 (l) 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 (P 80,000.00)
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 valid, 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 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.

Adopted: 20 Nov. 2008

(SGD.) ARTHUR C. YAP
Secretary, Department of Agriculture

RECOMMENDED BY:

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

(SGD.) JESUS EMMANUEL M. PARAS
Chairman, National Fisheries and Aquaculture Management Council