The Micro Criteria Regulation – what does it all mean?

Kaarin Goodburn CSci FIFST MSc BScFood Safety & Technology Management Consultant

Chilled Food Association: www.chilledfood.orgIFST, 7/4/06

Nothing Fundamentally New

… according to the European Commission:

“The Regulations do not bring any new obligations or new administrative

requirements for food businesses and do not cause additional costs for food businesses”

What is the Regulation all about?

HACCP

What’s it NOT about – Myths (1)

• Increased sampling of foods– NO! - no change to current HACCP-based approaches– BUT specified sampling frequency for minced meat/preps etc

• I have to test every batch– NO! - frequency is HACCP-based, determined by manufacturer

• 5 samples need to be tested per batch (e.g. RTE foods)– NO! - compositing is allowed for between comparable lots

• Positive release is required– NO! – using functioning HACCP-based systems is required

What’s it NOT about – Myths (2)

• Challenge testing required to demonstrate safe shelf life– NO! - hierarchy of approaches is set out in the Regulation

• Testing emphasised over control – diverts resources– NO! – having functioning HACCP-based systems is the

key legal requirement• It all means extra work for labs

– NO! – no change if sampling is already HACCP-driven

What does it do?

• Sets EU food safety & ‘process hygiene’ criteria• Harmonises many disparate legislated criteria in the

Member States• Relates these criteria to GMP and HACCP• Introduces common required action across the EU

on non-compliance• Sets the basis for EU official control (enforcement

sampling, predominantly at points of entry to the EU)

What has CFA been doing?• Lobbying to ensure clear HACCP focus

– FSA/authorities– European Commission

• Co-ordinating responses inc on costs – UK industry FSA– EU industry EC

• Factory/HACCP familiarisation visits for FSA negotiators• Developing guidance on practical implementation• Disseminating information

– Placing trade press articles – Challenging misreporting– Co-ordinating with FSA on external presentations

CFA/BRC Implementation Guidance

• Developed via industry working group - input from – trade organisations (producer/manufacture and retail)– independent specialists, RAs– FSA– HPA

• Designed to:– Help Food Business Operators (FBOs) to understand the

requirements– Provide a practical interpretation of the criteria

What do I have to do?• Implement GMP and HACCP: EU hygiene 852/2004 etc• Sample for HACCP verification purposes, compositing

across lots with EHO agreement • Carry out environmental swabbing:

– Lm (RTE food)– Enterobacter sakazakii (baby food/food for medical purposes)

• Test 5 samples of 1 minced meat/meat preparation etc a week per producer

• Relate shelf life for RTE products to Lm (<100/g)• Report confirmed exceedances of safety criteria to Local

Authority, FSA (via brand owner if own label)• React to exceedances of process hygiene criteria:

corrective action

Key point

Food safety is neither guaranteed nor

controlled by micro testing

• Testing is not a control measure• Micro testing of final product alone cannot be relied

upon to demonstrate product safety and may be insufficient to demonstrate due diligence

• Key is to be able to demonstrate functioning HACCP-based systems

Who does the Regulation apply to?

• Food Business Operators (production, retail, catering)– Use within HACCP systems (852/2004 requirement)– Most primary producers not affected directly– no criteria for unprocessed fruit and vegetables except for

sprouted seeds • Official Controllers

– At Border Inspection Posts, i.e. entry points to the EU– NOT envisaged by the EC to be applied in [regular] practice

between or within Member States unless surveys are being done or a problem investigated

Legal BasisRegulation 852/2004 (general EU Hygiene Regs)

i.e. HACCP (control) is king!

• Breaching the criteria is not itself against the law• Not taking action specified in the Regulation is, i.e. must

– Use the criteria in the context of food safety management systems based on HACCP principles to help show correct functioning

– Notify/withdraw if NOT within direct control of the producer if safety criteria exceeded (178/2002)

– Take internal corrective action (process/raw material) if process hygiene criteria exceeded

Emphasis on Testing?FSA FBO guidance:

“In many cases current practices may be sufficient to demonstrate compliance with the Regulation, as it is not

intended that there should be increased emphasis onmicrobiological testing where food safety management

procedures based on HACCP principles and good hygiene practices are in place and appropriate verification is carried

out.”

i.e. do HACCP and use criteria in validation/verification, as now

How should EHOs use the Regulation?

FSA FBO guidance:

“Enforcement officers must ensure that food business operators are complying with the Regulation. In the UK this will be either Local Authorities or the Port Health Authority.

FBOs will be required to provide evidence that the necessary food safety management procedures are in

place to ensure all relevant criteria are met”

i.e. FBOs must have properly functioning HACCP-based systems

Testing Frequency?

• The Regulations specify sampling plans, NOT frequencies• Except:

– Specified frequency only for minced meat/preparations/MSM/carcases:– One product per producer per week

• Sampling frequencies are otherwise driven by HACCP:– Risk-based frequency in practice– NO CHANGE to the level of testing required for foods where HACCP

verification testing is already in place• Testing will be adapted according to the company’s size

– ‘more simplified rules for SMEs concerning the testing obligation’– definition of ‘small business’ is to be left up to national authorities

level playing field?

What is a Batch?

“Batch” means a group or set of identifiable products obtained from a given process under

practically identical circumstances and produced in a given place within one defined

production period

i.e. samples of the same product can be composited across different lots

Testing Frequency & HACCP (1)• Determined by confidence in HACCP throughout supply chain

– the more confidence, the less testing required• Confidence achieved by:

– Auditing the supplier/producer and their HACCP including their micro checks, and/or

– Increasing the frequency of checks until sufficient historical data is available• Key elements to consider:

– Ingredients / raw material– Factory - design, hygiene of equipment, environment and people– Manufacturing process targeting appropriate organism/s– Packaging– Storage temperature and shelf life– Intended use– Food safety studies related to similar products

Testing Frequency & HACCP (2)

• Testing frequency may be reduced as – the HACCP plan becomes more established and – more satisfactory test results are obtained

• If anything significant changes e.g. raw material source, formulation or processing– Review HACCP– If appropriate, increase testing to build up a ‘refreshed’ database

• How, where and when to test: – CFA guidance on ‘Microbiological Testing and its Interpretation’

www.chilledfood.org/content/guidance.asp

Analytical Methods

• Specified reference methodsor• Alternative methods

– validated against the reference method – if a proprietary method: certified by a 3rd party in accordance with

the protocol set out in EN/ISO standard 16140 or other internationally accepted similar protocols,

or• Other methods

– validated according to internationally accepted protocols and use authorised by the competent authority (FSA/its agencies)

Food Safety Criteria• E coli (!)

– Live bivalve molluscs and echinoderms, tunicates and gastropods• Enterobacter sakazakii

– Dried infant formulae and dried foods for special medical purposes intended for infants <6 months• Histamine (!)

– Fishery products from fish species associated with high histidine• Listeria monocytogenes

– Many RTE foods • Salmonella

– Butter, cream and cheese from raw/non-pasteurised milk– Cooked crustaceans and molluscan shellfish– Egg products (except where processed to eliminate risk)– Gelatine and collagen– Ice cream (except where processed to eliminate risk)– Live bivalve molluscs, echinoderms, tunicates and gastropods– Milk and whey powder– Meat products– MSM– RTE products containing raw egg– RTE sprouted seeds, pre-cut fruit and vegetables– RTE unpasteurised fruit and vegetable juices

Process Hygiene Criteria• Aerobic Colony Count

– Carcases of cattle, sheep, goats, pigs and horses– Minced meat, MSM

• E. coli– Cheeses made from milk or whey that has undergone heat treatment – Meat preparations, MSM– Pre-cut fruit and vegetables, unpasteurised fruit and vegetable juices– Shelled and shucked products of cooked crustaceans and molluscan shellfish

• Enterobacteriaceae– Carcases of cattle, sheep, goats, pigs and horses– Egg products– Ice cream and frozen dairy desserts– Milk powder and whey powder– Pasteurised milk and other pasteurised liquid dairy products – Dried infant formulae, dried dietary foods for special medical purposes intended for infants <6 months of age

• Salmonella– Carcases of cattle, sheep, goats, pigs and horses– Poultry carcases of broilers and turkeys

• Staphylococcal enterotoxin – Shelled and shucked products of cooked crustaceans and molluscan shellfish – Cheese from raw/non-pasteurised milk– Unripened cheese made from pasteurised milk– Milk powder and whey powder

Not in the Scope• Primary agriculture, except for

– Shellfish – Sprouted seeds

• Pathogens– Bacillus cereus – EFSA: no point in setting criterion – Commission pressure still– Campylobacter – may come in the future– Clostridia – EFSA: no point in setting criterion – Protozoa – may come in the future– Viruses – may come in the future– VTEC – EC SCVPH: no point in setting criterion

• Spoilage/Quality– Coliforms– Lactic Acid Bacteria– Moulds– Pseudomonads– Yeasts

RTE Food = ?

Defined in the Regulation as:

“food intended by the producer or the manufacturer for direct human consumption without the need for

cooking or other processing effective to reduce to an acceptable level or eliminate microorganisms of

concern.”

Note

• It is up to the manufacturer to determine what is RTE• ‘Cooking’ is not defined• No target log reduction is specified, e.g. reheat

• For 6-log reduction of Lm: – 70ºC for 2 mins or – 75ºC instantaneous (current commonplace approach on reheat)

BUT • No/low levels of Lm present in practice• 1 log reduction: 70ºC for 20 secs

Listeria monocytogenes

• EC micro criteria strategy:‘RTE foods supporting the growth of Lm during the shelf-life of the

products are regarded as being of potentially high risk, e.g. vacuum-packed cold-smoked fish, pâtés, cheeses made from raw milk.’

• EC scientific opinion: “One of the key findings indicated that the vast majority of cases of listeriosis is associated with the consumption of foods that do not

meet current standards used for Lm in foods, whether that standard is zero tolerance or 100/g.”

i.e. HACCP/control is key to assuring safety

RTE Food - Which Lm Criterion?Is product intended for infants or for

special medical purposes?

yes Lm absent in 25g at end of shelf-life

No

Is product RTE? no No criterion for Lm appliesYes

Is product excluded in a footnote? yes No criterion for Lm appliesNo

Is pH < 4.4 or aW <0.92 or

pH < 5.0 & aW <0.94 or shelf life <5d or frozen at <-12ºC

yes Product unable to support Lm growth.

Limit of 100 cfu/g applies

No

Are sci/modelling, historic/etc data available to show that product won’t support Lm growth within shelf life?

yes Limit of 100 cfu/g applies

No

Will low levels of Lm, if present, grow to 100 cfu/g or more within shelf life

(expected storage conditions)?

yes Adjust shelf life so that limit of 100

cfu/g not reached when placed on the market

Lm Zero Tolerance for RTE foods?

• Zero tolerance – has no demonstrable impact on public health protection

afforded, e.g. USA experience - reiterated by WHO and EFSA– NOT the intent of the Regulation

• Zero tolerance (in 25g) applies– to RTE food able to support the growth of Lm – to those foods before they have left the immediate control of the

initial FBO IF – the manufacturer is NOT able to demonstrate that growth will not

exceed 100cfu/g throughout the shelf life

• How do you demonstrate this?

RTE foods: Lm growth v. shelf life

Remember:Shelf life (challenge) testing NOT a legal requirement

The Regulation is intended to be zero cost where HACCP applied

From the EC micro criteria Strategy:

‘…there is no need to conduct durability studies for all production lines of RTE foods, as in many cases the proper shelf-life of the product can be determined without expensive durability studies. It should be pointed

out also that for RTE products promoting the growth of Listeria and having a shelf-life less than 5 days there is no need to carry out

durability studies."

Lm and RTE Shelf Life Assessment

Approach hierarchy:• Scientific (e.g. pH, aw, literature)

– Won’t support growth, growth reported to be limited • Historical or other data

– Levels found in reality, i.e. when HACCP functioning (DOP, EOL)– Safety record of the product

• Model outputs (e.g. ComBase, Growth Predictor)– Won’t support growth, growth reported to be limited with the given

shelf life under expected storage conditions• Shared industry data on any of the above• If none of this available then consider shelf life or challenge

test studies

Lm Challenge Testing• No legal requirement to do this• If you have GMP, HACCP + supporting systems and follow the

shelf life approach you are not expected to have to carry it out

• Disadvantages of challenge testing:– Neither quick nor simple– Does not reflect either actual contamination levels nor the

physical state of organisms which may be expected to be present – Relates only to that specific product formulation/process

combination

The safety/stability of a product should instead be satisfactorily addressed during new product development

i.e. use HACCP in NPD

Historical Data• Best indication of an organism’s behaviour in a foodstuff

in reality• When present, Lm is from the environment, e.g.

– in a factory natural contaminants are likely to be stressed and will grow slower than those that have been grown for use in inoculation studies, i.e. in predictive models, challenge testing

• Data on Lm levels present at the beginning and at the end of shelf life can be used to assess growth potential

• Manufacturers should have a database for Lm consisting of appropriate samples taken at the beginning and end of life for each RTE product

Example Use of Lm Historical Data

If Lm detected in a RTE cooked meat product: • at the beginning of shelf life at a level of <10 cfu/g, and • data on a representative sample from the same batch at end

of life showed levels remained below 100 cfu/g Then...• the data help demonstrate that the product remains within the

Lm criteria over its shelf life• Under such circumstances, a low level (<10 cfu/g) detection

during shelf life should not need to be withdrawn

Issues in Practice….?• How does an official controller know whether a

product– The shelf life takes Lm into account?– It supports the growth of Lm or not?

• Will the official controller allow time for the FBO to provide any required data to substantiate shelf life, Lm growth prior to going public/notifying FSA?

Or will they assume zero tolerance applies and issue a RASFF/withdrawal notice?

Pre-emptive Measures

• FBOs need to discuss with official controllers/EHOs and ensure clear understanding of – The Regulation– The measures in place (HACCP, testing/shelf life

data)

Salmonella

Confirm before you notify

Presumptives/unconfirmed findings are NOT required to be notified

to the Competent Authority

• Action should only be taken on confirmed results unless there is written agreement to the contrary with the customer

• If an external laboratory is used, a written agreement must be in place covering communication of findings to the manufacturer and to any agreed third party

Salmonella and Minced Meat/Preps• Minced meat/preparations intended to be eaten raw

– Absence in 25g– If S detected withdraw from sale and notify

• Non-poultry minced meat/preparations intended to be eaten cooked – Absence in 10g– If S detected withdraw from sale and notify unless the

Derogation is in place and the product is on the home market• Poultry minced meat/preparations intended to be eaten

cooked – From 1/1/2006: absence in 10g– From 1/1/2010: absence in 25g– If S detected withdraw from sale and notify

Minced meat/preps - Cooking Instructions

• From 1/1/06-31/12/09 all minced meat/preparations etc intended to be eaten cooked must be clearly labelled by the manufacturer indicating the need for thorough cooking prior to consumption

– Provision of cooking instructions sufficient to achieve thorough cooking is considered to be suitable

Minced meat/preps etc Sampling

• Min. 1 batch of 1 product type of minced meat/preparation to be sampled once a week per production site

• 5 separate samples to be taken spaced out across production run

• Change the day sampling takes place each week so all production days are sampled over time

• Samples can be combined and tested for S spp. unless the transitional derogation is being used

Reduced sampling if…

• Testing frequency can be reduced if– Salmonella results (not detected) obtained for 30

consecutive weeks - can reduce from weekly to fortnightly

– there is a national or regional control programme demonstrating that prevalence in the animals/meat used to produce minced meat/preparations is ‘low’ (Competent Authority advice needed)

reduction on testing rate

Notes on minced meat/preps

• Establishments producing in small quantities (e.g. premises not requiring approval) are exempt from the sampling frequencies

• A representative sample of a batch cannot be taken at retail level

Minced meat/preps to be cookedDerogate or Not?

• FSA notified the EC of its uptake of the Transitional Derogation (until 31/12/09) - allows Salmonella in no more than 1 out of 5 samples, but– The samples must therefore be tested separately and– Product label must have a ‘special mark’ to show that produced under derogation– Product can only take advantage of the derogation in the country where it is

produced and sold • Products produced under the Derogation and those not can be

produced within the same production area at the same time• Disadvantages to the Derogation

– Extra costs: labelling, action (testing, reporting) – Barrier to trade, e.g. NI/Ireland

• FSA notified EC of intent to use the derogation• Will anyone use it?

Enterobacter sakazakii• Dried infant formulae and dried dietary foods for

special medical purposes intended for infants <6 months of age

• Monitor processing areas and equipment for Enterobacteriaceae

• Food safety criterion:– Enterobacter sakazakii absent in 10g when placed on the

market and the shelf life• Process hygiene:

– Enterobacteriaceae absent in 10g at the end of manufacture– Action on breach of criterion:

• Improve production hygiene to minimise contamination• Test the batch for Enterobacter sakazakii and Salmonella

Summary - What I have to do• Implement GMP and HACCP• Sample for HACCP verification purposes• Carry out environmental swabbing• Test 5 samples of 1 minced meat/meat

preparation a week per producer • Relate shelf life for RTE products to Lm (<100/g)• Report confirmed exceedances of safety criteria

to LA, FSA (via brand owner if own label)• Corrective action on exceedance of process

hygiene criteria

CFA Guidance Online• Free downloads from www.chilledfood.org:

– CFA/BRC guidance on the MCR – CFA Micro Testing and Interpretation Guidance

• CFA Best Practice Guidelines 4th edition– www.tsoshop.co.uk

• Others available via CFA web shop– http://shop.chilledfood.org

www.chilledfood.org

www.chilledfood.org/content/guidance.asp

cfa@chilledfood.org