RE: EU Spoilage vrs FDA Decomposition

From: Lupin, Hector (FIIU) (Hector.Lupin@fao.org)
Date: Mon Sep 20 2004 - 07:04:32 PDT

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    Dear Mr. Dion and other interested colleagues,
     
    To complete Peter's information, the current EU regulations in force, that
    form the "kernel" of HACCP-Hygiene regulations for fish and fish products in
    the EU are:
     

    * Council Directive 91/493/EEC - of 22 July 1991 laying down the
    health conditions for the production and marketing of fishery products and
    related regulations. This is the basic reference regulation. Can be
    downloaded from (HTML):

     
    <http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc
    &lg=EN&numdoc=31991L0493&model=guichett>
    http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&
    lg=EN&numdoc=31991L0493&model=guichett

     

    * Commission Decision 94/356/EC - of 20 May 1994 laying down detailed
    rules for the application of Council Directive 91/493/EEC with regard to
    health checks in fishery products. Can be downloaded from (HTML):

     

     
    <http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc
    &lg=EN&numdoc=31994D0356&model=guichett>
    http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&
    lg=EN&numdoc=31994D0356&model=guichett

     

         * Council Directive 93/43/EEC - of 14 June 1993 on the hygiene of
    foodstuffs. This is a general (horizontal) regulation on food hygiene, and
    may be applied in cases where there can be no coverage by the main fish and
    fish products regulations, like in fishmonger shops and fish restaurants.

     

     
    <http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc
    &lg=EN&numdoc=31993L0043&model=guichett>
    http://europa.eu.int/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&
    lg=EN&numdoc=31993L0043&model=guichett

     

    Please notice:

    1 - in all cases read More Info for amendments to the original regulation

    2- a set of new regulations will apply from January 2006 onwards (the one
    Peter mentions is one of them)

     

     

    -----------------------------------------------------------------------------
    --------------------------------------------------

     

     

    I do not want to enter in discussion with Peter, however, current EU
    regulations are explicit regarding the need of a review in addition to to
    "verification" in the "own checks"applied to fish and fish products:

     

    "In addition, it is necessary to review the system, to ensure that it is (or
    will be) still valid in case of change ... Where necessary, such a review
    must result in the amendment of the provisions laid down." (continues)

    (EU Decision 94/356/EC, 20 May 1994, Chap.III)
     
    This concept of review is also found in the general hygiene regulation
    (horizontal regulation):
     
    "- reviewing the analysis of food hazards, the critical control points and
    the control and monitoring procedures periodically and whenever the food
    business operations change"
     
    (EU Council Directive 93/43/EEC, 14 June 1993)
     
    I agree with Peter that in the EU regulations it is not specified a frequency
    for review (or verification), but audit is mentioned as one alternative for
    that:
     
    "Verification procedures may include: Inspection of operations, validation of
    critical limits, review of deviations, corrective actions and measures taken
    with regard to the product, audits of the own-check system and its records"
    (EU Decision 94/356/EC, 20 May 1994, Chap.III)
     
    Chapter III of EU Decision 94/356/EC is basic to understand the "review"
    concept in the EU regulations.
     
    As Peter says there is a tendency of the EU regulations to stick to Codex
    Alimentarius (this principle is already explicitly established in the EU
    Council Directive 93/43/EEC, but in any case EU regulations reserve the right
    to take provisions different from those approved at Codex level). There is
    more than one Codex committee working on the HACCP audit subject. in my
    personal opinion if there were not such amount of commercial interests in
    this subject, likely something would be already approved at Codex level.
     
    -----------------------------------------------------------------------------
    -------------------------------------------------------
     
    I do not think that there would be too much difference between "spoilage" and
    "decomposition" in conceptual (informal) terms, perhaps there are differences
    in formal definitions and with reference to which attributes and values are
    chosen to define either "spoilage" or "decomposition".
     
    The difference between both regulations is that in the case of EU regulations
    (assessed in first place by sensory analysis) spoilage is a "regulatory"
    hazard. In the case of US regulations spoilage is controlled in a different
    way, not as a "hazard" in the HACCP plan.
     
    I hope that it is clear that we are not interested in any discussion to
    ascertain who is "right" or "wrong" (e.g. in including or not "spoilage/
    decomposition" as a hazard in a HACCP plan). These discussions are to me as
    to the medieval discussion about "how many angels can dance on the top of a
    pin".
     
    -----------------------------------------------------------------------------
    -------------------------------------------------------
     
    Perhaps it is time again to express the practical reasons why we (FIIU/ FAO)
    are interested in this type of subject:
     
    (i) We are not interested to ascertain, for instance, if in some EU countries
    the fishery industry does not perform HACCP audits (definitely not in all of
    them because we know EU countries were the fish industry perform HACCP audits
    or "reviews" according to regulations). We could be worried about the
    possible inconsistency in implementation of regulations (if any); however,
    our main concern is with developing countries that should give proof of
    compliance with EU regulations to export.
     
    We know that some importers say to people in developing countries "do not
    worry about that, we do not ask for this or that part of the regulation", but
    we can not do that. We have to assume that if there is in the regulation (and
    some part of the EU fish industry follows it) then exporters can be
    (eventually) asked by EU fish inspector when inspecting/ auditing developing
    countries.
     
    (ii) We are not interested whatsoever in a theoretical comparison between EU
    and US regulations per se, and in the possible differences (that I personally
    do not think are really too much relevant from the point of view of risk to
    the consumer). Our problem here is to give advise to industry and inspection
    services in developing countries on how to to develop consolidated HACCP and
    hygiene plans that could suit simultaneously EU and US FDA regulations (also
    Canadian or other regulations if necessary).
     
    Both regulations (EU and US FDA) are enough flexible to allow for that. For
    instance nobody in the FDA will challenge you if in addition to the hazards
    that could appear in the FDA Hazards Guide you include "spoilage", or
    something else you think it is a hazard (for instance temperature control in
    your cold storage room). To put more requirements or to adopt more demanding
    regulatory limits (and therefore more demanding critical limits) is not a
    problem. Problems appear when you want to cancel something in your HACCP plan
    for B, because in the A regulation was not required.
     
    This flexibility allows exporters in developing countries to have, for
    instance, unitary hazard analysis; verification and review/ reassessment
    procedures done in a unitary way, etc. There is no sense to switch from one
    to other HACCP & Hygiene plans according to the country where the fish is
    going to be exported; it is costly and prone to confusion and mistake. This
    is an area in which the bilateral aid (technical assistance) is not
    interested at all (for obvious commercial reasons).
     
    Kind regards to all.
     
    Hector M. Lupin

    Senior Fishery Industry Officer (Quality Assurance)

    Fish Utilization and Marketing Service

    Fishery Industries Division / FAO of the UN

    Viale delle Terme de Caracalla 00100 Rome Italy

    Tel.: +39 06 570 56459 Fax: + 39 06 570 55188

    E-mail: hector.lupin@fao.org

    Please visit our website: http://www.fao.org <http://www.fao.org/>

     
     
     
     
     
     
     
     
     
     
     
     

    -----Original Message-----
    From: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu] On Behalf
    Of PDIONPDA@aol.com
    Sent: 19 September 2004 23:28
    To: seafood@ucdavis.edu
    Subject: EU Spoilage vrs FDA Decomposition

    Dear List Members,

    A short while ago Hector Lupin, while mentioning the fact that EU and USA
    HACCP could be different in regulations, he used the example of of "spoilage"
    as being an EU hazard while the FDA makes no mention of spoilage. If this is
    the case, how does EU "spoilage" differ from the FDA's "decomposition".

    If possible, could someone give me the web address for the EU HACCP
    regulations and explanations.

    Thank you in advance.

    Paul Dion
    Paul Dion Associates, Inc.
    Plymouth, MA
    USA



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