U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

                      (ON FDA LETTERHEAD)
                        August 16, 1995
 
 
               I N D U S T R Y  A D V I S O R Y
 
               EUROPEAN UNION(EU) REQUIREMENTS
    FOR UNITED STATES(US) FISH AND FISHERY PRODUCT EXPORTS
 
     This is an important notice for all US firms that
     ship, or plan to ship, fish or fishery products to
     the EU.
 
 
 
 
                           H A C C P
 
     The EU will require that by January 1, 1996, all seafood
companies in EU member states and those making product to ship
to the EU have in place an effective food processing control
program.  This program must be based on the principles of
HACCP (Hazard Analysis Critical Control Point).*
 
          This means that processing plants shipping to
          the EU will need to institute preventive
          controls, such as HACCP as soon as possible.
 
     Consequently, firms that ship to the EU are being advised
to implement HACCP before HACCP is required in the US.  The
January 1, 1996 effective date of the EU requirement is before
the anticipated effective date of FDA's Seafood HACCP
regulation.
 
     FDA advises that any US fish or fishery product processor
exporting to the EU consider using two FDA publications to
prepare to meet the EU requirements.  They are: the FDA HACCP
proposal of January 28, 1994, "Proposed Rule to Establish
Procedures for the Safe Processing and Importing of Fish and
Fishery Products," and the February 16, 1994, draft Fish and
Fishery Products Hazards and Controls Guide.  The proposal of
January 28 includes an explanation of the internationally
recognized principles of HACCP and how they can be applied by
a processor.  While the final version of the document may be
revised from the proposal, the principles of HACCP remain the
same.
 
     No change is anticipated in the health certificate.  The
certificates and list of accepted firms will continue to be
required by the EU until July, 1997.
 
 
--------------------------------------------------------------
* The EU term for HACCP in their documents is "own checks," as
in, "...persons responsible must carry out their own
checks..."
 
                          FDA'S ROLE
 
     FDA will continue the program to list acceptable firms
and sign certificates for exports to the EU.  Effective
January 1, 1996, the product must be processed under a HACCP
system.  US competent authority assurance by FDA of the
acceptability of US fish and fishery product exports will
continue to be used to minimize resistance to US exports in
the EU.
 
     The FDA list of US processors and signature on
certificates will relate to the use of HACCP by the industry.
Companies
seeking EU health certification for shipment to the EU need to
have a HACCP program in place by January 1, 1996.
 
     FDA recognizes that the changes in EU requirements**
described above may require the Agency to revise the
procedures for obtaining a certificate after January 1, 1996.
FDA is refining the implementation procedures for any
necessary changes for the Agency and industry.  A second
advisory will issue once this procedure is complete.
 
                 FRAMEWORK OR GLOBAL AGREEMENT
 
     The "Global Agreement" will be an agreement between the
EU and the US.  The goal of the "Global" or "Framework"
agreement is to establish procedures for equivalency
agreements on specific products such as seafood.  Equivalent
controls have the same public health goals (or animal health
goals), although the methods for achieving the goals may
differ.  The US delegates intend to reach such an agreement
for seafood, recognizing that the US system of controls
provides the same or a higher level of protection as the EU
system of controls.  These discussions are on-going.
 
                     THIRD COUNTRY VISITS
 
     US firms that export to the EU may be the subject of
audits by EU inspectors to check that our control systems are
equivalent starting in 1996.  The US Congress passed a bill
and the President signed it into law stating the United States
has accepted the World Trade Organization (WTO) agreement.
Under
 
______________________________________________________________
___
** FDA believes this advisory, plus the proposed rule and
"Hazard Guide" mentioned above, (and contained on the enclosed
disk in WordPerfect format) provide the HACCP information
manufacturers need to design an appropriate control program.
However, for those who want the applicable EU documents,
"COMMISSION DECISION of 20 May 1994" and "COUNCIL DIRECTIVE of
22 July 1991," copies are available from the FDA Office of
Seafood.  (See telephone number on page 1.)
 
that agreement, members of WTO, who are importer countries can
make visits to verify the controls implemented by exporting
countries.  Therefore, under the WTO agreement, the US shall
facilitate such visits.  FDA may accompany EU inspectors
during these audits to observe their activities.
 
     The EU has been conducting audits of third country firms
and regulatory control systems.  The audits by EU inspectors
have focused on major EU requirements.  For US processors this
means having a HACCP plan in operation, sanitation and GMP's
(good manufacturing practices).
 
     In a meeting between the US and EU officials in Brussels,
Belgium on June 14, 1995, EU officials favorably received
FDA's invitation to make several presentations in October 1995
directly to the US fish and fishery products industry.  The US
locations, dates, and times will be announced when the
arrangements are worked out and confirmed.  The presentations
would review and clarify EU directive requirements and
interpretations by EU
officials.  This will also provide an opportunity for face-to-
face dialogue between EU officials and US industry
representatives.
 
                          NMFS' ROLE
 
     NMFS is a recognized authority to issue EU health
certificates for firms on the list of US processors.  At a
meeting between EU and US representatives in June 1995, the EU
stated that it considers the NMFS "voluntary HACCP-based
program" as providing equivalent assurances to the EU
requirements.  NMFS inspectors may accompany EU inspectors on
visits to plants under that program.
 
                      MOVEMENT DOCUMENTS
 
     In addition to the human health certificates required by
the EU as a condition of entry into the EU market, animal
movement documents (certificates) pertaining to animal health
are also required by the EU for certain animals and products.
 
 
     These movement documents (certificates) may be obtained
from the US Fish and Wildlife Service (FWS) of the US
Department of the Interior, or the National Marine Fisheries
Service (NMFS) of the US Department of Commerce.  The Animal
and Plant Health Inspection Service (APHIS) of the US
Department of Agriculture issues certificates for live animals
or uneviscerated fish including farm-grown fish such as
salmonids, ornamentals and fresh water aquaculture fish.  FDA
does not issue such documents.  For further information,
contact Otis Miller, DVM, APHIS, USDA at (301) 734-7679.