Directorate-General for Health & Consumersfoodsafetyasiapacific.net/wp-content/uploads/2014/09/Food-Safety... · Directorate-General for Health & Consumers •Mycotoxins •Food Safety

Health and Consumers

Directorate-General for

Health & Consumers

• Mycotoxins

• Food Safety monitoring and surveillance

• Frans Verstraete


Principles for regulating mycotoxins in feed and food in the EU

• * Principles and requirements apply to all stages of the

production, processing and distribution of food and also of feed produced for, or fed to, food producing animals “farm to fork” approach

• Food and feed e.g. feed: analytical interferences to be taken into account

• * a high level of protection of human and animal health has to be pursued

• Mycotoxins: low level of presence / strict regulatory levels

•



• * free movement within the European Union of food

compliant with EU legislation

• Need to ensure comparable control results across the EU

• * international standards to be taken into account. • Need to ensure comparable control results across the

world •

* feed and food placed on the market shall be safe * contaminant levels shall be kept as low as can reasonably be achieved following good practices at all stages (ALARA)

•



• * In order to achieve the general objective of a high level of

protection of human health, EU feed/food legislation shall be based on risk analysis (process consisting of three interconnected components: risk assessment-risk management-risk communication)

• * Risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner

• * Risk management shall take into account the results of risk assessment, other factors legitimate to the matter under consideration and the precautionary principle where appropriate

•


The precautionary principle

• The precautionary principle provides that where, following an assessment of available information, the possibility of harmful effects on health has been identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the EU may be adopted, pending further scientific information for a more comprehensive risk assessment


The precautionary principle

• Measures adopted on the basis of the precautionary principle must be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, taking into account the technical and economic feasibility and other factors regarded as legitimate in the matter under consideration

• Such measures must be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment


Responsibilities for feed/food safety

• The EU legislation clearly establishes responsibilities for feed/food safety in the EU. Unsafe feed/food must not be placed on the market and it is the responsibility of feed/food business operator to ensure this. It is the responsibility of the competent authorities to carry out the appropriate controls on feed/food business operators official controls Regulation (EC) 882/2004 on official feed and food controls.


Traceability • The EU legislation GFL provides for a general

requirement that feed/food business operators trace feeds/foods under their responsibility.

• Feed/food businesses are required to know at least from whom a feed/food or feed/food ingredient has been supplied and to whom these may have been supplied. In other words, all businesses, including importers, will have to be able to identify one step up, and one step down the food and feed supply chain.


Rapid alert system

• Network of Commission, Member States and EFSA for the notification of a direct or indirect risk to human health and animal health deriving from food or feed

• Member States shall notify to the RASFF • Any measure taken for restricting the placing

on the market of forcing the withdrawal from the market or the recall of food and feed in order to protect human health and requiring rapid action

• Any rejection at a border post in the EU


Emergency measures

• In case it is evident that food or feed originating in the European Union or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment, emergency measures can be adopted to protect public and animal health.


Challenges for enforcement of mycotoxins in feed and food - general

• Development of adequate sampling procedures: representative and feasible – heterogeneity –large size batches – estimation of sampling uncertainty

• Methods of analysis + measurement uncertainty • Confirmatory • Screening

• Screening approach (not only analysis but also sampling): sampling and analysis – very low rate of false negatives – acceptable rate of false positives growing importance for the enforcement in particular in the field of mycotoxins


Maximum / guidance / indicative levels

• Maximum levels • Feed and food placed on the market shall comply with the maximum levels.

Maximum levels are safety levels. Feed and food not compliant with the maximum levels (taking into account the measurement uncertainty) shall not be placed on the market or withdrawn/recalled from the market.

• Guidance values • Feed and food placed on the market should comply with the guidance levels.

Guidance for accepting or rejecting lots. Guidance levels are established taking into account the toxicity for humans, sensitivity of different animal species. Some flexibility possible in enforcement.

• Indicative values • Indicative levels are not safety levels. Exceedance of the indicative values

trigger actions /investigations to be undertaken: investigations on the sources and the reasons for the increased levels and related mitigation measures, on the fate during processing and any other relevant investigations.


Mycotoxins regulated in the EU

• In food – maximum levels

aflatoxin B1, aflatoxin total (B1+B2+G1+G2), aflatoxin M1, ochratoxin A, patulin, deoxynivalenol, zearalenone, fumonisin B1+B2

• In food – indicative values

T-2 + HT-2 toxin

• In feed – maximum levels

aflatoxin B1, ergot (sclerotia)


Mycotoxins regulated in the EU

• In feed – guidance values

ochratoxin A, deoxynivalenol, zearalenone, fumonisin B1+ B2

• In feed – indicative values

T-2 + HT-2 toxin

• Recommendations for the prevention and reduction of

- Patulin contamination in apple juice and apple juice ingredients in other beverages

- Fusarium toxins in cereals and cereal products


Strategy - sampling

• Adequate sampling procedure is of crucial importance for estimating lot average levels in case contaminants are heterogeneously distributed throughout a lot (as is the case for aflatoxins, ochratoxin A,…) and is therefore in these cases an essential component in the development of any maximum level

• exporter’s risk/producer’s risk against importer’s risk/consumer’s risk: EU policy is that a sampling procedure must be practicable and must minimise the consumer’s risk without rendering trade impossible


Regulation 401/2006 sampling mycotoxins

• Replaces 4 Commission directives: 98/53/EC (aflatoxins), 2002/26/EC (ochratoxin A), 2003/78/EC (patulin) and 2005/38/EC (Fusarium-toxin)

• One single sampling method per commodity for the official control of mycotoxins


Regulation 401/2006 sampling mycotoxins • Cereals and cereal products • Dried fruit with the exception of figs

• Vacuum packs

• Dried figs • Vacuum packs

• groundnuts and nuts • Vacuum packs – high risk/low risk/particle size

• Spices • Vacuum packs

• Milk and milk products; infant formulae and follow-on formulae, including infant milk and follow on milk


Regulation 401/2006 sampling mycotoxins

• Coffee and coffee products • Vacuum packs

• Fruit juices including grape juice, grape must, cider and wine

• Solid apple products and apple juice and solid apple products for infants and young children

• Baby foods and processed cereal based foods for infants and young children


Sampling procedures Definitions

• Lot: an identifiable quantity of food delivered at one time and determined by the official to have common characteristics

• Sublot: designated part of al large lot in order to apply the sampling method on that designated part. Each sublot must be physically separate and identifiable


sampling procedure cereals and cereal products

• On the condition that the sublot can be separated physically, each lot of more than 50 tonnes shall be subdivided into sublots according to following table:

Commodity Lot weight

(tonne)

Weight or

number of

sublots

N° incremental

samples

Aggregate

sample

Weight (kg)

Cereals and

cereal products 1500

>300 and <1500

50 and 300

< 50

500 tonnes

3 sublots

100 tonnes

--

100

100

100

10-100 *

10

10

10

1-10


sampling procedure cereals and cereal products

• Incremental sample: 100 g

• Each (sub)lot shall be separately sampled

• Number of incremental samples for • consignments > 50 tonnes: 100

• consignments < 50 tonnes 3-100 – see table next slide

• Weight of the aggregate sample • consignments > 50 tonnes: 10 kg

• consignments < 50 tonnes: 1-10 kg (at least 1 kg)


sampling procedure- cereals and cereal products

• Number of incremental samples for lots < 50

tonnes

Lot weight

(tonnes)

No of incremental

samples

Aggregate sample weight

(kg)

0.05 3 1

> 0.05 - 0.5 5 1

> 0.5 - 1 10 1

> 1 - 3 20 2

> 3 - 10 40 4

> 10 - 20 60 6

> 20 - 50 100 10


sampling procedure cereals and cereal products • If it is not possible to carry out the method of

sampling because of commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc …) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

• An alternative method of sampling may also be applied in cases where it is practically impossible to apply the sampling method (e.g. large static lots) guidance document


sampling procedure dried fruit except figs


Commodity Lot weight (ton) Weight or

number of

sublots

N°

incremental

samples

Aggregate

sample

weight (kg)

Dried fruit 15

<15

15-30 tonnes

-

100

10-100*

10

1-10




• Each (sub) lot shall be sampled separately







• Number of incremental samples for lots < 15 tonnes

Lot weight

(tonnes)

N° of incremental

samples

Aggregate sample

weight (kg)

0.1 10 1

> 0.1 - 0.2 15 1.5

> 0.2 - 0.5 20 2

> 0.5 - 1.0 30 3

> 1.0 - 2.0 40 4

> 2.0 - 5.0 60 6

> 5.0 - 10.0 80 8

> 10.0 - 15.0 100 10



• If it is not possible to carry out the method of sampling because of commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc …) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.

• special sampling procedure for vacuum

packing


sampling procedure- dried figs

• On the condition that the sublot can be separated physically, each lot of more than 15 tonnes shall be subdivided into sublots

according to following table:


(tonne)

Weight or

number of

sublots

N°

incremental

samples

Aggregate

sample

weight (kg)

Dried figs 15

< 15

15-

30tonnes

--

100

10-100*

30

30


sampling procedure - dried figs

• Weight of incremental sample: 300 grams • Number of incremental samples for

• consignments > 15 tonnes: 100 • consignments < 15 tonnes 10-100 – see table next slide

• Weight of the aggregate sample • consignments > 15 tonnes: 30 kg • consignments < 15 tonnes: 3-30 kg • in case of products for direct human consumption : 30 kg

to be thoroughly mixed, to be divided afterwards into 3 equal subsamples, every single subsample to be homogenised separately and to be analysed separately

• in case of products for further sorting: division in 3 subsamples not necessary.


sampling procedure - dried figs


Lot weight

(tonnes)

N° of

incremental

samples

Aggregate

sample

Weight (kg)

No of laboratory

samples from

aggregate sample

0.1 10 3 1 (no division)

> 0.1 - 0.2 15 4.5 1 (no division)

> 0.2 - 0.5 20 6 1 (no division)

> 0.5 - 1.0 30 9 (- < 12 kg) 1 (no division)

> 1.0 - 2.0 40 12 2

> 2.0 - 5.0 60 18 (- < 24 kg) 2

> 5.0 - 10.0 80 24 3

> 10.0 - 15.0 100 30 3


sampling procedure –dried figs



packing


sampling procedure - dried figs • Derived products with very small particle weight, i.e.

flour, peanut butter (homogeneous distribution)

• Weight of the incremental sample 100 gram

• Number of incremental samples for lots > 50 tonnes: 100


Lot weight (tonnes) N° of incremental

samples

Aggregate sample

weight (kg)

1 10 1

> 1 - 3 20 2

> 3 - 10 40 4

> 10 - 20 60 6

> 20 - 50 100 10


sampling procedure -dried figs derived products

• Derived products with relatively large particle weight, (heterogeneous distribution)

• Method of sampling and acceptance as for dried figs


sampling procedure groundnuts,other oilseeds apricot kernels and nuts



(tonne)

Weight or

number of

sublots

N°

incremental

samples

Aggregate

sample

weight (kg)

Groundnuts,

other oilseeds,

apricot kernels

and tree nuts

500

>125 and <500

15 and 125

< 15

100 tonnes

5 sublots

25 tonnes

--

100

100

100

10-100*

20

20

20

20


sampling procedure groundnuts, other oilseeds apricot kernels and nuts

• Weight of incremental sample: 200 grams • Number of incremental samples for

• consignments > 15 tonnes: 100 • consignments < 15 tonnes 10-100 – see table next

slide

• Weight of the aggregate sample • consignments > 15 tonnes: 20 kg • consignments < 15 tonnes: 2-20 kg • in case of products for direct human consumption : 20

kg to be thoroughly mixed, to be divided afterwards into 2 equal subsamples, every single subsample to be homogenised separately and to be analysed separately

• in case of products for further sorting: division in 2 subsamples not necessary.




Lot weight

(tonnes)

N° of

incremental

samples

Aggregate sample

Weight (kg)

No of laboratory

samples from

aggregate sample

0.1 10 2 1 (no division)

> 0.1 - 0.2 15 3 1 (no division)

> 0.2 - 0.5 20 4 1 (no division)

> 0.5 - 1.0 30 6 1 (no division)

> 1.0 - 2.0 40 8 (- < 12 kg) 1 (no division)

> 2.0 - 5.0 60 12 2

> 5.0 - 10.0 80 16 2

> 10.0 - 15.0 100 20 2





packing



• Derived products (other than vegetable oil) with very small particle weight, i.e. flour, peanut butter (homogeneous distribution)

• Weight of the incremental sample 100 gram

• Number of incremental samples for lots > 50 tonnes: 100



samples

Aggregate sample

weight (kg)

1 10 1

> 1 - 3 20 2

> 3 - 10 40 4

> 10 - 20 60 6

> 20 - 50 100 10



• Derived products with relatively large particle weight, (heterogeneous distribution)

• Method of sampling and acceptance as for groundnuts and nuts


sampling procedure - spices • On the condition that the sublot can be

separated physically, each lot of more than 15 tonnes shall be subdivided into sublots according to following table:

Commodity Lot weight (ton) Weight or

number of

sublots

N°

incremental

samples

Aggregate

sample

weight (kg)

Spices 15

<15

25 tonnes

-

100

5-100*

10

0.5-10


sampling procedure - spices

• Incremental sample: 100 g • Each (sub) lot shall be sampled separately • Number of incremental samples for

• consignments > 15 tonnes: 100 • consignments < 15 tonnes 5-100 – see table

next slide

• Weight of the aggregate sample • consignments > 15 tonnes: 10 kg • consignments < 15 tonnes: 0.5-10 kg (at

least 1 kg)


sampling procedure - spices



samples

Aggregate sample

weight (kg)

0.01 5 0.5

> 0.01 - 0.1 10 1

> 0.1 - 0.2 15 1.5

> 0.2 - 0.5 20 2

> 0.5 - 1.0 30 3

> 1.0 - 2.0 40 4

> 2.0 - 5.0 60 6

> 5.0 - 10.0 80 8

> 10.0 - 15.0 100 10


sampling procedure spices



packing


sampling procedure coffee, coffee products,

liquorice root and liquorice extract



(ton)

Weight or

number of

sublots

N°

incremental

samples

Aggregate

sample

weight (kg)

Roasted coffee beans,

ground roasted coffee

and soluble coffee

15

<15

15-30 tonnes

-

100

10-100*

10

1-10


sampling procedure coffee, coffee products, liquorice root and liquorice extract


• Each (sub) lot shall be sampled separately







Number of incremental samples for lots < 15 tonnes

Lot weight

(tonnes)

N° of incremental

samples

Aggregate sample

weight (kg)

0.1 10 1

> 0.1 - 0.2 15 1.5

> 0.2 - 0.5 20 2

> 0.5 - 1.0 30 3

> 1.0 - 2.0 40 4

> 2.0 - 5.0 60 6

> 5.0 - 10.0 80 8

> 10.0 - 15.0 100 10





packing


sampling procedure vegetable oil

• Incremental sample: at least 100 g (ml)

• Each (sub)lot shall be separately sampled


sampling procedure vegetable oil

• Number of incremental samples to be taken from a lot

Form of commer-

cialisation

Weight of lot (in kg)

Volume of lot (in litres)

Minimum number of

incremental samples to

be taken Bulk * - 3

packages ≤ 50 3

packages > 50 to 500 5

packages > 500 10


sampling procedure vegetable oil • On the condition that the sublot can be

separated physically, each lot of more than 50 tonnes shall be subdivided into sublots according to following table:


(tonne)

Weight or

number of

sublots

Minimum N°

incremental

samples

Aggregate

sample

Weight (kg)

Vegetable oils 1500

>300 and <1500

50 and 300

< 50

500 tonnes

3 sublots

100 tonnes

--

3

3

3

3

1

1

1

1


Sampling procedure vacuum packs

• Dried fruit with the exception of dried figs, spices, roasted coffee beans, ground roasted coffee, soluble coffee, liquorice root and liquorice root extract

• For lots equal to or more than 15 tonnes at least 25 incremental samples resulting in a 10 kg aggregate sample shall be taken and for lots less than 15 tonnes, 25 % of the normal number of incremental samples shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot.



• Dried figs

• For lots equal to or more than 15 tonnes at least 50 incremental samples resulting in a 30 kg aggregate sample shall be taken and for lots of less than 15 tonnes, 50 % of the normal number of incremental samples shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot



• Pistachios, groundnuts and Brazil nuts • For lots equal to or more than 15 tonnes at least 50

incremental samples resulting in a 20 kg aggregate sample shall be taken and for lots less than 15 tonnes, 50 % of the normal number of incremental samples mentioned shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot.

• Apricot kernels, tree nuts other than pistachios and brazil nuts, other oilseeds • For lots equal to or more than 15 tonnes at least 25

incremental samples resulting in a 20 kg aggregate sample shall be taken and for lots less than 15 tonnes, 25 % of the normal number of incremental samples mentioned shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot.



• Products derived from nuts, figs and groundnuts with small particle size

• For lots equal to or more than 50 tonnes at least 25 incremental samples resulting in a 10 kg aggregate sample shall be taken and for lots less than 50 tonnes, 25 % of the normal number of incremental samples shall be taken resulting in an aggregate sample of which the weight corresponds to the weight of the sampled lot.


Acceptance of a lot or sublot

• Cereals and cereal products, spices, coffee and coffee products, dried fruit with the exception of dried figs • acceptance if the laboratory sample

conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty;

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty..



• For dried figs, groundnuts, other oilseeds, apricot kernels and nuts subjected to a sorting or other physical treatment:

• acceptance if the aggregate sample or the average of the laboratory samples conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty;

• rejection if the aggregate sample or the average of the laboratory samples exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.



• For dried figs, groundnuts, other oilseeds apricot kernels and nuts intended for direct human consumption • acceptance if none of the laboratory samples exceeds the maximum

limit, taking into account the correction for recovery and measurement uncertainty;

• rejection if one or more of the laboratory samples exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty.

• In cases where the aggregate sample is 12 kg or less:

• acceptance if the laboratory sample conforms to the maximum limit, taking into account the correction for recovery and measurement uncertainty;

• rejection if the laboratory sample exceeds the maximum limit beyond reasonable doubt taking into account the correction for recovery and measurement uncertainty;


Samples for defence and reference –figs (most common)

Sample for enforcement

Sample for defence

Sample for reference

Place of sampling

Laboratory

Incremental

Samples

(100)

Aggregate

sample

Pre-

Mixing

Sub-

samples

Homoge-

nisation

Sample

division

Samples for enforcement, defence and reference taken from homogenised

laboratory or subsamples

30 kg each 10 kg

Replicate

Samples

Homogenised subsamples

each 10 kg


Sample for defence



Sample for defence



Samples for defence and reference for figs (very few MS)

Place of sampling

Laboratory

Aggregate

sample

Pre-

Mixing

Sub-

samples

Homogeni-

sation of

complete

subsamples

Sample

division

Samples for enforcement, defence and reference taken parallel from the consignment


Replicate sample

Replicate sample

3 x 30 kg each 10 kg

Replicate

samples

Incremental

Samples

(3 x 100)


Replicate sample

Replicate sample

Sample for defence

Replicate sample

Replicate sample



Sample for defence

Sample for defence




Samples defence and reference/peanuts, oilseeds and nuts (most common)

Sample f or en forc ement

Sample f or de fe nce

Sample f or refere nce

Place of samplin g

Laboratory

Incremental

Samples

(100)

Aggregate

sample

Pre-

Mixing

Laboratory

samples

Homoge-

nisation of

complete

laboratory

samples

Sample

division

Samples for enforcement, def ence and ref erence t aken from homogenised

laboratory or subsamples

20 kg each 10 kg

Replicate

Samples

Homogeni se d

laboratory

sample s

each 10 kg

Sample f or en forc ement

Sample f or de fe nce

Sample f or refere nce


Samples defence and reference for peanuts, oilseeds and nuts (very few MS)

Place of sampling

Laboratory

Aggregate

sample

Pre-

Mixing

laboratory-

samples

Homogenisation of

complete laboratory

samples

Sample

division

Samples for enforcement, defence and reference taken parallel from the consignment

2x 20 kg each 10 kg

Replicate

samples

Incremental

Samples

(2 x 100 incr.)

= 2 x (100 inc.x 200 g)


Replicate sample

Sample for defence

Replicate sample


Sample for defence


Sample preparation

• Laboratories must be accredited according EN ISO/IEC 17025 « General requirements for the competence of testing and calibration laboratories »

• Exclusion of daylight (aflatoxin breaks down under UV light

• complete homogenisation of the complete sample

• homogenisation with shell or without shell (aflatoxins) • in case of homogenisation with shell: assumption all

contamination is in the edible part (kernel) -- recalculation according ratio nut/kernel (known ratio or determined by making use of 100 nuts)!


Sample preparation

• Sample preparation must be available in the lab as Standard Operating Procedure (SOP) and must be covered by accreditation

• Laboratory must demonstrate that the used homogenisation procedure achieves complete homogenisation

• Samples for enforcement, trade and referee purposes to be taken from the homogenised material (see previous slide)


Method of analysis

• Performance criteria based approach.

• Advantage: does not avoid making use of technological progress and newest technologies and laboratories can use the analytical method most appropriate for their facilities

• includes parameters such as detection limit, repeatability, coefficient of variation, reproducibility recovery for various levels


Example: Aflatoxins - Method of analysis - Performance criteria

Criterion Concentration

Range Recommended

Value

Maximum

permitted Value

Blanks All Negligible -

Recovery - Aflatoxin M1 0.01-0.05 g/kg 60 to 120 %

> 0.05 g/kg 70 to 110 %

Recovery-Aflatoxins B1, B2, G1, G2

< 1.0 g/kg 50 to 120 %

1 - 10 g/kg 70 to 110 %

> 10 g/kg 80 to 110 %

Precision RSDR All As derived from Horwitz Equation

2 x value derived from Horwitz Equation

Precision RSDr may be calculated as 0.66 times Precision RSDR at the concentration of

interest


Ochratoxin A – Method of analysis - Performance criteria

Level Ochratoxin A

µg/kg RSDr % RSDR % Recovery %

< 1 40 60 50 to 120

1 - 10 20 30 70 to 110


Second opinion

• Operators have the right of a second opinion in case of a non-compliance

• Three approaches identified in EU in case the defence sample generates a compliant result • Supersedes the official result -> lot released • Reference sample analysed in national

reference laboratory: analytical result decisive

• Operator must challenge the analytical result of the official sample before Court


REPORTING OF ANALYTICAL RESULTS

• Corrected or uncorrected for recovery. The manner of reporting and the level of recovery must be reported

• Analytical result to be reported as x +/- U whereby x is the analytical result and U the expanded measurement uncertainty

• Expanded measurement uncertainty, using a coverage factor of 2 , which gives a confidence interval of approx. 95 %

• Detailed report on relationship analytical results, measurement uncertainty and recovery: http://ec.europa.eu/comm/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf


INTERPRETATION OF ANALYTICAL RESULTS

• A consignment is considered as non-compliant if analytical result, corrected for recovery exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty


INTERPRETATION OF ANALYTICAL RESULTS

Interpretation of the measurement of uncertainty when considering compliance with a statutory limit, where the circle is the analytical result.

maximum

limit

( i )

Result less

uncertainty

above limit

( iv )

Result plus

uncertainty

below limit

( ii )

Result

above limit

but limit

within

uncertainty

( iii )

Result below

limit but limit

within

uncertainty

Action: reject accept accept accept


71

Legislation on official controls Reg. 882/2004

• General obligations

• Member States shall ensure that controls are carried out

on a regular basis, on a risk basis and with an

appropriate frequency to achieve the objectives taking

account of:

* identified risks

* experience and knowledge gained from previous controls

* reliability of controls already carried out by food and feed business operators (own-controls)

* suspicion of possible non-compliance


72

Legislation on official controls Reg. 882/2004

• General obligations (cont’d)

• the official controls are carried out without prior warning (as a general rule) and

• at any stage of production, processing and distribution • official controls must be applied with the same care to

exports, to the placing on the market within the Union and on the import


73

Regulation 882/2004 Competent authorities

• Competent authorities shall ensure

• the effectiveness and appropriateness of official controls

• to have access to adequate laboratory capacity and sufficient suitably qualified staff

• that staff carrying out the control is free from any conflict of interest


74

Regulation 882/2004 Import controls

• Controls on the import of feed and food

• Regular official controls at an appropriate place (point of entry / point of release for free circulation/ premises of food business / other points of the chain)

• controls include documentary check (always), an random identity check and, as appropriate, a physical check


75

Regulation 882/2004 Import controls

• Controls on the import of feed and food (cont’d) • frequency of physical checks function of

* possible risks associated with food commodities

* history of compliance (product, establishment of operator, importing operator, exporting operator, third country)

* controls carried out by the importer

* guarantees provided by competent authorities of third country


76

Regulation 882/2004 Sampling and analysis

• Sampling and analysis methods used in the context of official controls shall comply with relevant Union rules or • if none exist, internationally recognised rules or

protocols, for example those that the European Committee for standardisation (CEN) has accepted or those agreed in national legislation

• if none exist, other methods fit for the intended purpose or developed in accordance with scientific protocols


77


• In case the above mentioned does not apply, validation of methods of analysis may take place within a single laboratory according to an internationally accepted protocol


78


• Wherever possible, methods of analysis shall be characterised by the following appropriate criteria: • accuracy,

• applicability (matrix and concentration range)

• limit of detection

• limit of determination

• precision

• repeatability

• reproducibility


79


• Characterisation by appropriate criteria (cont’d):

• recovery • selectivity • sensitivity • linearity • measurement uncertainty • …

• precision values (from collaborative trial conducted in accordance with e.g. ISO 5725: 1994 or IUPAC International Harmonised Protocol)


80


• Where performance criteria for analytical methods are established, they must be based on criteria compliance tests

• repeatability and reproducibility values must be expressed in an internationally recognised form (e.g. 95 % confidence intervals)

• methods of analysis which are applicable uniformly to various groups of commodities should be given preference over methods which apply only to individual commodities


81


• The Commission may lay down

• methods of sampling and analysis, including the confirmatory or reference methods to be used in the event of a dispute

• the performance criteria, analysis parameters, measurement uncertainty and procedures for the validation of such methods

• rules on the interpretation of the results


82

Accreditation requirement Regulation 882/2004

• Laboratories (Article 12)

• Competent authority shall designate laboratories that may carry out the analysis of samples taken during official control

• Competent authorities may only designate laboratories that operate and are assessed and accredited following EN ISO/IEC/17025 on “General requirements for the competence of testing and calibration laboratories”

• The accreditation and assessment of laboratories relate to individual tests or groups of tests


83

Regulation 882/2004 List for feed and food at risk

• Controls on the import of feed and food (cont’d) • establishment of a list of “food - origin” that on the basis

of known or emerging risk shall be subject to increased level of official controls at the point of entry. Frequency and nature of these controls and the fees related to such controls to be established. For the organization of these controls, CA shall

* designate particular points of entry

* require food business operators responsible for consignment to give prior notification of their arrival


84

Approval of pre-export checks by third countries

• Specific pre-export checks that a third country carries out on feed and food immediately prior to export to the EU may be approved for one or more products

• Where such an approval has been granted, the frequency of import controls may be reduced as a consequence. A reduced level of controls is maintained to ensure that the pre-export checks remain effective


85


• Approval of pre-export checks is granted if • a Union inspection have shown that food exported to

the EU meets EU requirements • controls carried out in the third country prior to

dispatch are considered sufficiently effective and efficient as to replace or reduce the documentary, identity and physical checks at import.

• Designation of competent authority (CA) responsible for pre-export - control body that the CA may delegate tasks

• CA or control body ensure the official certification and approval of pre-export shall specify the model for such certificates


86


• If it is found that in a significant number of consignments the goods do not correspond to the information in the certificates issued by the CA of country of origin, the reduced frequency of controls shall no longer apply.


EURL – NRL network : objectives

• * Regulation (EC) No 882/2004 provides for the establishment of an European Union Reference Laboratory (EURL) / National Reference Laboratory (NRL) network in different areas of food safety

• * EURL/NRL network should contribute to a high quality and uniformity of analytical tasks

• * the tasks and duties of the EURL/NRL provided for in the Regulation aim to achieve this objective.


Regulation 882/2004 – Article 32 Tasks and duties of the EURL

• The EURL shall be responsible for

• Providing NRLs with details of analytical methods, including reference methods

• Co-ordinating application by NRLs of the methods, in particular by organising comparative testing and by ensuring an appropriate follow-up of such comparative testing in accordance with internationally accepted protocols

• Co-ordinating practical arrangements needed to apply new analytical methods and informing national reference laboratories of advances in this field


Regulation 882/2004 - Article 32 Tasks and duties of the EURL

• The EURL shall be responsible for (cont’d) • Conducting initial and further training courses for the

benefit of staff from national reference laboratories and of experts from developing countries

• Providing scientific and technical assistance to the Commission, especially in cases where Member States contest the results of analysis

• Collaborating with laboratories responsible for analysing feed and food in third countries


Regulation 882/2004 – Article 33 Tasks and duties of the NRL

• * Member States designate one or more reference laboratories (NRLs) for each European Union laboratory (may be a laboratory in another Member State or EFTA Member, one lab can be NRL for more than one Member State.

• * In case Member States gave more than one NRL for one EURL, they must ensure that these laboratories work closely together to ensure efficient co-ordination between them, with other national laboratories and with the European Union reference laboratory.


Regulation 882/2004 – Article 33 Tasks and duties of the NRL

•These NRLs shall •Collaborate with EURL

•Co-ordinate for their area of competence the activities of official laboratories

•Organise where appropriate comparative tests between the official national laboratories and ensure follow-up of such comparative testing

•Ensure the dissemination to the competent authority and official national laboratories of information that the EURL supplies

•Provide scientific and technical assistance to the competent authority for the implementation of co-ordinated control plans


Standardisation of methods

• * Standardised methods of analysis are of importance to guarantee the safety of feed and food and to ensure the free circulation of feed and food within the EU

• * DG Health and Consumers intends to establish methods of analysis only in very specific cases as regards safety of feed and food.

• * Standardisation of methods is largely entrusted to CEN (European Standardisation Committee)

• * European Commission addresses mandates for standardisation to CEN to provide standards of methods of analysis and sampling within a certain time period


What is RASFF?

• Legal basis: Articles 50-52 of Regulation (EC) 178/2002 (food law)

• information on food and feed which present a risk to the health of consumers.


Members of the RASFF

European Food Safety Authority

European Commission

EFTA Surveillance Authority

Austria Greece Poland Iceland Belgium Hungary Portugal Norway Cyprus Ireland Slovakia Liechstenstein Czech Republic Italy Slovenia Denmark Latvia Sweden Estonia Lithuania Spain Finland Luxembourg United Kingdom France Malta Bulgaria Germany Netherlands Romania


Alert Notifications • Food or feed for

which a serious risk has been identified

• Product is on the market

• Immediate action is required by members of the network


Informations Notifications

• Food or feed for which a serious risk has been identified but no rapid action required on the product

Or • Not a serious risk

but useful for food/feed control in other member countries


Border Rejections Notifications

• Any rejection, related to a direct or indirect risk, of a batch, container or cargo of food or feed at a border post


News Notifications

• Information related to the safety of food/feed

• Not communicated as an ‘alert’ or an ‘information’

• But judged interesting for the control authorities


Criteria for notification

• Food and feed for which exists a direct or indirect risk to human health

• Since 2006 also animal health and environmental threat for feed: this includes pet food!

• Basis is EU legislation or if not harmonised: national legislation



• Prohibited substances or ingredients

• Unauthorised substances or ingredients

• Exceeding of legal limits

• Unauthorised establishment for food of animal origin



• Unauthorised novel food / GM food

• Physical risk (foreign bodies)

• Incorrect labelling / improper health certificate implying health risk /

• Other risk based on risk assessment


MEMBER COUNTRY NOTIFICATION

RASFF ASSESSMENT

FEEDBACK FROM

MEMBER COUNTRIES

RASFF TRANSMISSION

MEMBER

COUNTRIES

THIRD COUNTRY

CONCERNED

Business/Consumer

FEEDBACK FROM THIRD COUNTRY

CONCERNED

WEEKLY OVERVIEW

ANNUAL REPORT

Border Control

Market Control

Third country/Media

Media


RASFF findings

• As driving force for new legislation

• As basis for safeguard measures

• As basis for increased frequency of controls at import

• As basis for FVO inspections


Effective Enforcement

• Importance of representativeness of sampling and reliability of analysis: to guarantee that once controlled at an early step in the feed and food production chain that feed and food is safe and is found compliant also at later stages: no need for recalls etc

• Importance of quick/rapid sampling analysis (but reliable) • Industry HACCP/autocontrol: need for quick and reliable

results to ensure “fluent” ongoing production process and to avoid unreasonable production costs

• Control authorities (see next slide)


Effective Enforcement –Importance of quick, but reliable sampling and analysis

•

• Official controls have to be carried out regularly on a risk basis and with the appropriate frequency

• at random (non suspicion) – in these cases sampled lot as a rule not detained

late analysis can have large consequences

– On the safety of the consumer

– Economic cost: large recalls


Effective Enforcement-Importance of quick, but reliable sampling and analysis

• in case of suspicion – in these cases sampled lot as a rule detained late analysis can have large consequences

– Deterioration of the quality and safety of the sampled lot pending analysis

– Economic cost of blocking the goods pending analysis: time is money! Seasonal products / delivery just in time


Effective Enforcement not only reliable and quick analysis

• * Keep period of time between arrival lot and sampling as short as possible

• * Ensure representative feasible sampling

• * Keep period of time between sampling and arrival of sample at laboratory as short as possible

• * Ensure Reliable and quick sampling analysis

• * Ensure that reporting of the result to the responsible inspector is done as soon as possible after analysis


108

Setting enforcement in context Building blocks of control system

Risk-based controls and prioritisation of activities, including enforcement activities (Resource allocation/Databases/results of previous controls)

Legislation in place, including, where necessary, enforcement legislation specific to each MS

Clearly defined competent authorities and responsibilities, including for enforcement activities

Co-ordination between bodies responsible for controls and bodies responsible for enforcement. Formal? Outcomes?

Who does what, and when? Business processes for enforcement? IT based?

Effective enforcement is a necessary element of effective compliance


109

(3) PDCA cycle-applies also to enforcement


110

Enforcement strategy

Risk-based controls

Dialogue with industry/operators

Incentives/dissuasive measures

Measurement of effectiveness of enforcement activities

Annual Report: Links between Controls → Non-compliances → Enforcement activities

Annual Reports should analyse overall trends in enforcement

Review mechanism

KEY POINTS

Documents

Directorate-General for Health & Consumersfoodsafetyasiapacific.net/wp-content/uploads/2014/09/Food-Safety... · Directorate-General for Health & Consumers •Mycotoxins •Food Safety