MessageDear Hector,
Each time I am approaching the condition of being ready for the "psy" after suffering from exotic interpretations of the EU regulations, you point out the matter.
In fact, many European (national services inspectors, going on time to time to give some "help" to third countries) spread the idea of all hygiene aspects being associated to critical points. I so manuals and guidelines proposing HACCP model plans containing about 15 critical points for the most simple case of little processes raw product...Additionally the regulation introduce the idea of "own-checks" supposed to be equivalent to HACCP but they do not trust in the companies "own-control" and, as a consequence in many third countries, the inspectors are still convinced that the results depends on the inspector presence and interference.
About limits of temperature the interpretations ca be really extreme. My view is that frozen storage should no be considered a CCP. How important should be a deviation for involving the idea of "Hazard", given in the point (c) bellow?.
But what do you think about rejecting (with consequent destruction) tons of lobsters because not arriving alive either at a temperature of 0°C to +2°C (the criteria for fresh fish in the 493, but referred to the transportation and preservation of fresh product in the respective chapter, being a final product and not a raw material) having the only problem of being captured and not having the time to cool down in the abundant ice present!!!
The problem comes from mixing "hygiene" with process parameters control, and taking out from its intention and framework certain regulatory texts.
(b) CCP is called "Critical Point"
(c) "Hazard is a potential to cause harm to health and is anything covered by the hygiene objectives of Directive 91/493/EEC" (bold and Italics mine)
In addition, with the horizontalisation of regulation, the situation will suffer further deterioration.
Tanks for the opportunity to talk about ,
Best regards
Oscar do Porto
International Consultant
----- Original Message -----
From: Larry Wyatt
To: Lupin, Hector (FIIU)
Cc: richard@fishonline.co.uk ; alma tina ; seafood@ucdavis.edu
Sent: Tuesday, October 11, 2005 6:33 PM
Subject: Re: inquiry about cold storage being considered as CCP
Hector,
I think your explanation of the difference between HACCP and regulatory actions based on HACCP is excellent, and more important, is that it is too often overlooked.
Larry Wyatt
FoodHorizon Inc.
www.foodhorizon.com
Lupin, Hector (FIIU) wrote:
Dear colleagues:
This is a very interesting discussion, that pops up very frequently. I think that there are some general considerations:
(i) Regulatory HACCP is not HACCP (e.g. in the sense of HACCP according the Codex Alimentarius) but a regulation based on HACCP. Therefore, in principle, you have to comply with a regulation and not just with the dry HACCP principles and/ or steps.
(ii) Regulations, as any other piece of knowledge, is open to interpretations. "Interpretations" are usually a problem. Inspection agencies in general make every possible effort to make interpretations, of their own officers, uniform. But not always succeed.
(iii) One of the aspects of HACCP-based regulations is that they determine directly or indirectly "regulatory hazards"; this means hazards that you shall be taken into account in your HACCP plan, regardless which could be your own technical opinion. In the case of the US FDA HACCP-based regulations theoretically you may eventual appeal (if you are in the US), based on scientific grounds. However, for most "regulatory hazards" the possibility somebody could demonstrate they are not hazards (e.g. histamine in pelagic fish) is usually very remote.
Regarding the EU directives there are a couple of things to clarify (translate from EU English to USA English):
(a) HACCP for fish and fish products is called "own-checks".
(b) CCP is called "Critical Point"
(c) "Hazard is a potential to cause harm to health and is anything covered by the hygiene objectives of Directive 91/493/EEC" (bold and Italics mine)
(from Commission Decision 94/356/EC of 20 May 1994)
Going to Council Directive 91/493/EEC we found the following:
(1) "- frozen fishery products, with the exception of frozen fish in brine intended for the manufacture of canned foods, must be kept at an even temperature of -18 º C or less in all parts of the product, allowing for the possibility of brief upward fluctuations of not more than 3 º C, during transport;" (Council Directive 91/493/EEC, Annex, Chapter VIII, Storage and Transport, Point 1) (bold mine)
(2) "3. Storage rooms must have a temperature recording device in place where it can easily be read. The temperature sensor of the recorder must be located in the area furthest away from the cold source, i.e. where the temperature in the storage room is the highest. Temperature charts must be available for inspection by the supervisory authorities at least during the period in which the products are stored." (Council Directive 91/493/EEC, Annex, Chapter IV, Special Conditions for Handling Fishery Products on Shore, II Conditions fro frozen products, Point 3) (bold mine)
And finally, and perhaps the most important for this discussion:
(3) "Critical limits may be derived from a variety of sources. When not taken from regulatory standards (e.g. frozen storage temperature) or from existing and validated guides of good manufacturing practices, the team should ascertain their validity relative to the control of identified hazard and critical points" (Commission Decision 94/356/EC, Chapter II, Point 1). (bold mine)
In this case the regulation is not saying that the cold storage temperature is a CP (a CCP); but is given all the indications in that sense (critical limit, tolerance, measurement and record keeping and use it as regulatory example). The need for corrective actions, in the case of deviations, is obviously a result; and the need for verifications of measurement and record equipment fall into the general principle of verification and calibration and re-calibration of measurement equipment. Therefore we have our regulatory hazard and CP (or CCP).
Again, the possibility that in this situation a fish inspector from the EU do not consider the temperature in a cold storage room a CP (a CCP) is remote. He/ she may eventually accept that continuous records could be replaced by recorded lectures, say every 3-5 hours (taking into account the thermal inertia of cold storage rooms); but hardly that it is not a CP (CCP).
The discussion about the rationality or not of frozen storage temperature as a CP (or CCP) is interesting; I am tempted to go on that, but not time now. In any case we should keep in mind that HACCP based regulations (or by the case all Risk Analysis) are based on Science, they are not Science.
I have worked with people in developing countries that want to export their fish. People normally ask you to provide an advice that put them into the safe side. Which advise would you provide in this case?
(Warning: from 1 January 2006 there will be a new set of EU regulations dealing with HACCP, and a new careful reading of regulations is necessary for all trading fish with the EU)
Kind regards.
Hector M. Lupin
Senior Fishery Industry Officer (Quality Assurance)
Fish Utilization and Marketing Service (FIIU)
Fishery Industries Division (FI)
Fisheries Department, FAO, Room F 606
Viale delle Terme di Caracalla
00100 Rome, Italy
Tel + 39 06 570 56459
Fax + 39 06 570 55188
E-mail: hector.lupin@fao.org
-----Original Message-----
From: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu] On Behalf Of Richard Chivers
Sent: 07 October 2005 16:36
To: alma tina; seafood@ucdavis.edu
Subject: RE: inquiry about cold storage being considered as CCP
Hi Alma,
<!--[if !supportEmptyParas]--><!--[endif]-->
These are my views:
<!--[if !supportEmptyParas]--><!--[endif]-->
1.. There are no EU directives that set CCPs, these are up to the processor to determine.
2.. I assume you refer to the Competent Authority. I would not consider cold (frozen) storage a CCP simply because a product that is intended to be kept in be frozen condition would be in breach of specifications and GMP, drawing in quality and safety issues. I would set the temperature control as a prerequisite programme; a given if you like. I.e. if the product temperature were outside the limits, that would be the end of it for its primary purpose and disposal or alternative use should be considered.
3.. Pathogen growth is unlikely to present a food safety hazard due to the reasonable expectation that the product would be cooked. That is unless there were an issue with spore formers or with heat resistant toxins then there would be a problem. These matters would be highlighted in the analysis part of the HACCP. Unfortunately it is not an argument that sways opinion in international trade which will set stringent micro counts.
4.. It is not illegal but may mean that your analysis was invalid if a CCP were missed. In the UK this alone would not lead to prosecution but could become evidence to support a prosecution if there were more serious matters arising from temperature abuse i.e. food poisoning.
<!--[if !supportEmptyParas]--><!--[endif]-->
I hope this helps
<!--[if !supportEmptyParas]--><!--[endif]-->
Richard Chivers
<!--[if !supportEmptyParas]--><!--[endif]-->
-----Original Message-----
From: owner-seafood@ucdavis.edu [mailto:owner-seafood@ucdavis.edu]On Behalf Of alma tina
Sent: 07 October 2005 06:34
To: seafood@ucdavis.edu
Subject: inquiry about cold storage being considered as CCP
<!--[if !supportEmptyParas]--><!--[endif]-->
Dear List,
Please give me some insight or enlightening regarding the issue of considering cold storage as CCP.
These are my questions:
1.Is there an EU directives that considers storing at cold storage as CCP.
2.Can the competitive authority insist on us to consider storing at cold storage as CCP.
3. Is my thinking correct, that since our product is to be fully cooked before consumption, then pathogen growth is not a hazard? By the way our products are frozen octopus and shrimps.
4. Is it illegal not to have CCP for a particular item?
Plese provide some information on this issue, we badly needed the info.
Thanks,
Alma O. Tina
--------------------------------------------------------------------------
Yahoo! for Good
Click here to donate to the Hurricane Katrina relief effort.
This archive was generated by hypermail 2b29 : Tue Oct 11 2005 - 15:06:44 PDT