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© FSAI
HACCP Requirements in the European Union
Mary Friel PhD
Food Safety Authority of Ireland
Workshop on strengthening food safety in small and
less developed food businesses
Botswana, November 28th – December 1st 2006
© FSAI
Overview of presentation
� Overview of food hygiene legislation in EU
� Regulation 852/2004: HACCP requirements
� HACCP Flexibility
� Training
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EU legislation: ‘The Hygiene Package’
Directive 2004/41
Directive 2002/99
Reg. 854/2004
Reg. 853/2004
Reg. 852/2004
Directive to Repeal existing rules
Directive on Animal Health
Regulation on Official Controls of foods
of animal origin
Regulation on hygiene of foods of animal
origin
Regulation on hygiene of foodstuffs
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HACCP requirements
under
Regulation 852/2004
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HACCP Requirement: Article 5 (1)
‘Food business operators shall put in place,
implement and maintain a permanent procedure
or procedures based on the HACCP principles’
= shall have a system based on HACCP principles
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HACCP Principles
1. ‘identifying any hazards that must be prevented, eliminated or reduced to acceptable levels
2. identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels
3. establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards
4. establishing and implementing effective monitoring procedures at critical control points
5. establishing corrective actions when monitoring indicates that a critical control point is not under control
6. establishing procedures, which shall be carried out regularly, to verifythat the measures outlined in subparagraphs (a) to (e) are working effectively
7. establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f)
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Food Business Operators (FBOs) are also
required to……..
�Review the HACCP based procedures when modifications are made to the process or product
�Provide the Competent Authority (CA) with evidence of their compliance
�Ensure documents are kept up-to-date & are retained for an appropriate length of time
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Who must comply with the HACCP requirement of
Regulation 852/2004?
ALL food businesses with the
exception of primary producers
& associated operations
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Legal Basis: Recital 15 & Article 5 of Regulation 852/2004
Guidance:
http://ec.europa.eu/food/food/biosafety/hygienelegislation/guidance_doc_haccp_en.pdf
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i) Hazard analysis
ii) Critical limits
iii) Monitoring
iv) Documents & records
Flexibility in the application of HACCP principles
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i) Hazard analysis
Formal hazard analysis not required by a business …..
� where it can be presumed that due to its nature all the hazards are controlled by implementing the prerequisite hygiene requirements correctly
� that is following a generic HACCP guide
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ii) Critical Limits
Critical limits can be chosen where they are:
� In a recognised guide to good practice
� In internationally accepted standards (e.g. Codex)
� Based on experience of the operation in question
Non-numerical critical limits are permitted if valid, e.g.
Looking for the changes in the physical properties of food during cooking
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iii) Monitoring
Monitoring may in many cases be a simple procedure, e.g. a visual observation or check of:
� the temperature recorded on the temperature dial/display unit of refrigeration/freezing facilities
� the physical properties of food subjected to a particular heat treatment
e.g. boiling of liquid food demonstrated by liquids bubbling when stirred
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iv) Documents & Records
HACCP related documentation should be:
• appropriate to the nature & size of the business
• assist businesses verify that HACCP controls are in place
• well balanced & limited to what is essential for food safety
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HACCP related documentation should include:
1. Documents on HACCP based procedures:
Guides to good practice can substitute individual documentation on HACCP based procedures
2. Records on measurements and analysis carried out:In the case of visual monitoring, records can be limited to measurements of non-compliance (i.e. ‘recording by exception’) and the corrective action must also be recorded
Records on GHP/prerequisites:
Must be maintained where food safety so requires,
e.g. maintenance of the cold chain
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Retention of records:
For an ‘appropriate time’ - i.e. to ensure information is available for trace back in the case of an alert, e.g.
2 months after the date of consumption of food (where such a date is known)
•
• or
If date of consumption is unknown, then a short period after the expiry date
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Training……..
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Those responsible for the development and maintenance of HACCP based procedures or for the operation of relevant guides must receive adequate training in the application of the HACCP principles
Adequate training:
� Does not necessarily involve participation in training courses
� Could be achieved through information campaigns from professional organisations or from the competent authorities
� should be proportionate to the size and the nature of the business.
© FSAI