Dr Ramunas Freigofas

DG SANTE

European Commission

The EU Management System for Contaminants and Microbiological criteria Residues of pesticides and veterinary medicines

Mycotoxins and heavy metals

Microbiological criteria

The regulatory lifecycle of a PPP

3

Regulation (EC) No

1107/2009 on placing of

PPP on the market

Directive 2009/128/EC on

Sustainable Use of

Pesticides

Regulation (EC) No

396/2005 on MRLs of

pesticides

Horizontal legislation, esp. Regulation (EC) No 178/2002 General Food Law

EU Pesticide Legislation

Active substance Formulated Product

"Approval" vs. "Authorisation"

Separation risk assessment / risk management

6

Industry

1 Member State (RMS)

European Food Safety Authority (EFSA) + all Member States

EFSA

Commission + all Member States

Data dossier

Draft Assessment Report

Expert meetings, Peer review of the DAR

"Conclusion on the peer review"

(Restricted) approval / Non-approval

2. Risk Assessment

1. Application

3. Risk management

Active Substances = Approval at EU level • Application for approval

• Data requirements

• Evaluation shared between 28 Member States: for each substance => one Rapporteur MS

• Uniform principles of evaluation

• Peer review by the European Food Safety Authority

• Approval =>List of approved substances • http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=homepage&language=EN

• Total length of the procedure = 2,5 to 3 years

• First approval for 10 years – renewal for up to 15 years

Plant Protection products = Authorisation at national level

• In assessing applications, Member States evaluate the active substance- and the product-dossier

• In granting authorisations, Member States set out the requirements for placing on the market, e.g.:

- classification

- conditions of use

- labelling

• Member States enforce compliance with the authorisation

• Commission monitors and controls Member States activities

Need for renewal of approval

• Approvals for active substances are limited in time and require systematic

periodic renewal:

- every 15 years for regular active substances (first approval period: 10 years)

- every 7 years for candidates for substitution

• - shorter periods for specific cases (e.g. glyphosate)

• Substances subject to renewal of approval are grouped in batches ("AIR-

programme")

• Applicant is supposed to submit information addressing progress in scientific

and technical knowledge and changes in legal requirements

9

Food can circulate freely on the EU market

(domestic and imported)

Regulation 396/2005

Guarantee a high level of protection

for all EU consumers

Pesticide Maximum Residue Levels (MRLs)

established at EU level

Pesticide residues

Pesticide residues

• Ensure a harmonised high level of consumer protection:

• No unacceptable risk to humans

• MRL set at lowest achievable level consistent with most critical Good Agricultural Practices (GAPs)

• Protecting vulnerable groups (children, unborn)

Directive 2006/141/EC, Directive 2006/125/EC: Baby Food Directives

• Cumulative and synergistic effects

• Public health > interest of crop protection

• Free circulation of food and feed in EU

• Transparency and predictability

• Provisions for third countries (imports into EU)

How are MRLs set?

Residues

expected in food

Food

consumption

Toxicological

limits + +

3 parameters to be considered

Pesticide residues

Evaluation by European Food Safety Authority

Decision making at the Standing Committee PAFF-Section Residues

General principles for MRL setting

• Consumer safety vs trade facilitation

• Consumer risk assessment based on toxicological reference values

• TMDI/ADI

• IESTI/ARfD

• ALARA

• OECD calculator since 2012

• default value/LOQ, not zero tolerance

Regulation (EC) No 396/2005–setting EU MRLs

Evaluation by

Rapporteur Member

State

EU Application

EFSA advice

Import

tolerance

request

Review of

existing MRLs

Codex MRLs

Regulation

setting,

modifying or

deleting

MRLs

Non-renewal of

approval

From application to MRL setting (MRL applications based on EU uses and import tolerance requests)

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APPL EFSA EMS/RMS

SC PAFF (28 MS)

COM

Council & EP

MRL COM

dossier ER RO

draft act

vote scrutiny adoption

≈ 1 year 3-6 months

≈ 3 months

1-2 months < 1 month 2 months

Evaluation of EU pesticide legislation

• Objective: to assess if the needs of citizens, businesses and public institutions are met in an efficient manner

• REFIT: rolling programme to keep the entire stock of EU legislation under review and ensure that:

i) it is 'fit for purpose'

ii) regulatory burdens are minimised

iii) all simplification options are identified and applied

• Ex-post evaluation - BACKWARD LOOKING!

• Report to Council and Parliament in first half of 2019

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Involvement of non EU countries in REFIT evaluation

• Stakeholder survey • Several TCs provided contribution

• Evidence on the impact on trade

• Interviews • In the framework of the case studies

• Haloxyfop in linseed from Russia and Kazakhstan

• Sulfoxaflor in citrus fruit from South Africa, Turkey and Chile

• Thiabendazole in sweet potatoes and mangoes from USA and Brazil

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Cut-off Criteria Criteria for approval of substances

• Plant protection products containing the substance must:

a) be sufficiently effective;

b) have no immediate or delayed harmful effect on human health, including that of vulnerable groups, or animal health,

c) have no unacceptable effects on plants or plant Products

d) shall not cause unnecessary suffering to vertebrates to be controlled

e) shall have no unacceptable effects on the environment (biotic and abiotic)

Exclusion from approval for substances of high concern (health or environment):CMR Cat 1A or 1B, POP, PBT, vPvB, endocrine disruptor

• Limited derogation possibilities for some of these criteria are provided

Complex decision making, alignment BP & PPP

• Based on an impact assessment

• roadmap 2014

• public consultation 2015

• impact assessment based on a screening study 2016

• Criteria (delegated act BP; implementing act PPP)

• draft criteria in June 2016 (same for PPP and BP)

• consultation TBT / SPS (3rd countries) & general public in 2016

• negotiation with Member States and scrutiny of the Council and the European Parliament (comitology procedure) from 2016 to 2018

• 2017: adoption & scrutiny of BP criteria

• 2017 / 2018: scrutiny & adoption of PPP criteria

transparency: https://ec.europa.eu/health/endocrine_disruptors/next_steps_en

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The Criteria in the Context of the Mandates

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• The criteria are limited to hazard identification

• They do NOT include hazard characterisation (no potency)

• They do NOT define how to regulate EDs – this is already set out in the two Regulations

• No categories – mandates in both Regulation are only to distinguish whether a substance is ED/not ED in the PPP/BP regulatory contexts

Impact of cut-off criteria on MRLs

Non-renewal

decision

Non-

compliance

with cut-off

criteria

Deletion of existing

MRLs, including Import

Tolerances No renewal

process –

expired

approval

Neither

approved nor

non-approved Default MRL applies

New IT

request

undergo risk

assessment

Involvement of risk managers in the process

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(a) Level of Consumer Protection

PERCENTILE (P50, P90, P95, P99, P99.9, P99.99)

MOE THRESHOLD (100????)

APPROACH: POPULATION or CONSUMERS ONLY

Retrospective (Post-Marketing) CEA

(b) Assumptions influencing Exposure Estimation

HARMONISED APPROACH AMONG EU MEMBER STATES

(e.g. missing values imputation,

non-detects, processing factors)

Uncertainty?

FUTURE WORK

Management Decisions? (e.g. lowering

MRLs?, banning a.s.?)

HARMONISED EU APPROACH

State of play

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Retrospective (Post-Marketing) CEA

(a) Level of Consumer

Protection

(b) Assumptions influencing

Exposure Estimation

Note Taking PAFF 18-19 Sep 2018

Cumulative Risk

Assessment

Uncertainty

Evaluation

Cumulative Exposure

Assessments

Reports on 2 CAGs

COMMUNICATION STRATEGY

EU Database on Maximum Residue Levels

Other information for the public

• Educational material by DG Health and Food Safety

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_approval-factsheet.pdf

http://ec.europa.eu/assets/sante/food/plants/pesticides/lop/index.html

• Educational material by EFSA

https://www.efsa.europa.eu/en/discover/infographics/who-assesses-pesticides-eu

https://www.efsa.europa.eu/en/topics/topic/pesticides

Information on MRLs

• Guidance document on MRL setting procedure (SANTE/2015/10595 Rev. 4 — June 2016)

Detailed technical and procedural guidance

http://ec.europa.eu/food/plant/pesticides/max_residue_levels/guidelines/index_en.htm

• SPS Note to non-EU countries about Art. 12:

https://ec.europa.eu/food/sites/food/files/plant/docs/pesticides_mrl_guidelines_mrl-review_en.pdf

• Legal texts: http://eur-ex.europa.eu/homepage.html

•EFSA overview on MRL review programme:

https://www.efsa.europa.eu/sites/default/files/pesticides-MRL-review-progress-report.pdf

26

Import tolerances and Codex Maximum Residue Limits

New MRLs established based on

• GAPs in EU

• GAPs in Third Countries ("import tolerances"): proof of authorisation and MRL in Third Country

• Codex Alimentarius standards: annual alignment to new CXLs, unless concerns

• Same level of stringency in assessment

MRLs valid for

• Commodities from EU and Third Countries:

same MRL for all food and feed on the EU market

Provisions for imported food

• EU MRLs apply to imported food => no need to request an import tolerance if EU MRL is sufficient

• If EU MRL not sufficient, applicant can request import tolerance based on GAP authorised in Third Country

• Same data requirements, but proof of authorisation and domestic MRL needed

• Same level of stringency in assessment

• Same timelines for evaluation and decision

Codex Alimentarius and EU MRLs

• Generally Codex Maximum residue limits (CXLs) are taken over in EU legislation unless the EU raised concerns at CCPR ("reservation")

• "Old" CXLs are implemented during the MRL review procedure, if safe to consumers (EFSA evaluation)

• Newly proposed CXLs are assessed in an annual EFSA scientific report (in preparation of each Codex Committee on Pesticides Residues (CCPR) meeting)

• Provisional analysis shows that EU has smallest proportion (28%) of MRLs lower than CXLs adopted 2012-2016, compared to four other major markets

Development of policy on contaminants in food

Types of contaminants determine the nature of the measure

• Agricultural contaminants

• E.g. nitrates, mycotoxins (aflatoxins, ochratoxin A)

• Inherent plant toxins

• Environmental and industrial contaminants

• E.g. heavy metals (mercury, lead, cadmium, etc.), dioxins, PCBs

• Process related contaminants

• E.g. acrylamide, furans, PAHs

• Other

• Unavoidable carry over of coccidiostats in non-target feed

• Residues of biocides (not elsewhere covered)

Framework Regulation 315/93 Provisions

• General provision:

• food containing a contaminant in an amount which is unacceptable from the public health viewpoint and in particular at a toxicological level shall not be placed on the market

• Good practice:

• contaminant levels shall be kept as low as can reasonably be achieved following good practices at all stages (ALARA)

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Framework Regulation 315/93 Provisions

When necessary for protecting public health maximum levels shall established for specific contaminants --> Procedure for setting maximum levels. This can also include a reference to the sampling and analysis methods to be used.

Obligatory consultation of the European Food Safety Authority(EFSA) Panel on contaminants in the food chain before provisions having effect upon public health shall be adopted.

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Prevention and Regulation

• “prevention is better than cure” to protect the consumer (humans and animals) from the toxic effect of mycotoxins / contaminants need for encouraging preventive actions such as good agricultural practice, good storage conditions, good manufacturing practice, …

• Fixing maximum limits is not contrary to prevention. Fixing maximum levels at a reasonably achievable level, stimulates preventive actions at all stages to avoid contamination of the feed/food chain.

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Different types of standards: Maximum / action / guidance / benchmark 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.

MYCOTOXINS: Need for a comprehensive strategy: Challenge ! • Prevention

• Resistent/tolerant varieties • Agricultural practices (<-> environmental constraints) • Storage and transport conditions • …

• Mitigate the toxic effects of mycotoxins • Mycotoxin binders • Mycotoxin detoxifying products /additives • ….

• Detoxification • Acceptability criteria • …

• Last but not least – Regulation/regulatory measures • Maximum levels • Guidance levels • …

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Other provisions of relevance to the application of maximum levels

• Food containing a contaminant exceeding the ML shall not be placed on the market

• Maximum level does apply to edible part

• For dried, diluted, processed or compound foodstuffs: concentration/dilution factors, relative proportion of the ingredients apply insofar no specific EU MLs have been established for these dried, diluted, processed or compound foodstuffs

•38

Driving forces for initiating new EU-legislation on contaminants

• Contamination incidents with “new” (not yet regulated) contaminants: melamine, …

• New (at EU level) risk assessments: non-dioxin like PCBs, inorganic arsenic, …

• Updated risk assessments: cadmium, PAH, mercury, ochratoxin A, lead, …

• Developments in risk assessment approaches

• Risk-benefit assessment: nitrates in vegetables • Margin of Exposure (MOE): genotoxic carcinogens such as

aflatoxins, PAH

Driving forces for initiating new EU-legislation on contaminants

• “Emerging” contaminants: Brominated flame retardants (BFR), PFOS/PFOA, Alternaria toxins, 3-MCPD esters, glycidyl esters, enniatins, …

• Changing production conditions/ climate change: Mycotoxins, phytotoxins (?)

• International developments within the Codex Alimentarius : lead in fish,

aflatoxins, melamine, …

• Identified problems with current legislation:

Commission Recommendations on prevention and reduction -mycotoxins

• 2003/598/EC: prevention and reduction of patulin contamination in apple juice and apple juice ingredients in other beverages

• 2006/583/EC: prevention and reduction of Fusarium-toxins in cereals and cereal products

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Commission Recommendations on monitoring – metals

• 2014/193/EU: reduction of the presence of cadmium in foodstuffs

• Recommendation (EU) 2015/1381: monitoring of arsenic in food

• Recommendation (EU) 2016/1111: monitoring of nickel in food

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Commission Recommendations on monitoring –metals

• Recommendation (EU) 2018/464: monitoring of metals and iodine in seaweed, halophytes and products based on seaweed.

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Safeguard measures

Commission Implementing Regulation (EU) 884/2014

• As the consequence of frequent findings of (high) levels of aflatoxins

exceeding the maximum levels: Special measures to protect public health

as regards pistachios from Iran and Turkey, peanuts (groundnuts) from

Egypt, China, India, Ghana, Brazil and Argentina, dried figs from Turkey,

hazelnuts from Turkey and Azerbajan, Brazil nuts in shell from Brazil,

watermelon seeds from Nigeria, spices from India and Ethiopia, Nutmeg

from Indonesia

• Derived, processed and compound foodstuffs included in scope of the

Regulation.

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Approval of pre-export checks carried out by third countries

Commission Implementing Regulation (EU) 2015/949 of 19 June 2015 approving the pre-export checks carried out on certain food by certain third countries as regards the presence of certain mycotoxins

• Aflatoxins – almonds – US

• Ochratoxin A – wheat – Canada

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Microbiological hazards and EU food law

Contents

• EU legislation on microbiological hazards

• Microbiological criteria (Reg (EC) 2073/2005)

• Food Safety Criteria vs Process Hygiene Criteria

• STEC food safety criteria

• Official controls and microbiological testing

• import of food of non-animal origin (FNAO)

EU food law - microbiological hazards: preventive approach

Reg. 178/2002*

Reg. 852/2004*

Reg. 853/2004

Reg. 854/2004

Reg. 882/2004*

Reg. 2073/2005*

…

Reg. 2160/2003

Control salmonella

and other specified

zoonotic agents

National Control

Programmes (NCP’s) and targets

Directive 2003/99

Monitoring

and reporting

Zoonotic agents

Foodborne outbreaks

AMR

Food Hygiene

Legislation Zoonoses Regulation

Zoonoses Directive

Reg.183/2005

Feedstuffs

*FNAO

Microbiological testing alone can never guarantee the safety of the foodstuff tested.

The safety of foodstuffs is principally ensured by a structured preventive approach (GHP)

EU food law - microbiological hazards: preventive approach

Reg. (EC) No 2073/2005 – microbiological criteria

Article 4 Regulation (EC) No 852/2004

Tool to be used by FBO

Preventative approach, risk based

Criteria established in support of Food Hygiene Legislation

The use of microbiological criteria should form an integral

part of the implementation of Food Safety Management

System (FSMS) and other hygiene control measures

Reg. (EC) No 2073/2005 – microbiological criteria

Criteria apply to Food Business Operators (FBO) however the

limits apply to samples taken for official control (Reg

882/2004) to verify the criteria have been met.

FBO’s should use the criteria to validate and verify the correct

functioning of their food safety management procedures

MAIN OBJECTIVES:

To ensure a high level of human health protection

To harmonise microbiological criteria

Uniform rules for food business operators

Reg. (EC) No 2073/2005 – microbiological criteria

Reference methods to guarantee a uniform

application and control of legislation in EU

Food safety criteria Process hygiene criteria

Defines the acceptability of the

product/butch

Applicable to products placed on the

market

Applicable to intra-EU trade and to

imported products from third

countries

Indicates the acceptable functioning of the

production process

Applicable only during the production

process, not to products placed on the

market

Action: withdrawal/recall Action: improvement of production

hygiene, selection of raw materials

Microbiological criteria

What happens if the criteria limits are not met? FBOs must carry out corrective actions if a food exceeds the relevant

criteria limit. Official Control audits the actions

Food Safety Criteria withdrawn/recalled

• Further processing or treatment ( not at retail )

• Other corrective actions

Process Hygiene Criteria

• Improvement of production hygiene

• Selection of raw materials

In both cases look at the FSMS and revise if required.

• Persistent failure = ineffective FSMS

• Micro-organism of concern

• Analytical method

• Sampling plan

• Number of sample units

• Size of the analytical unit

• Microbiological limits

• Foodstuff

• Point of the food chain where the limit applies

• Actions to be taken when unsatisfactory results

Concept of Microbiological Criteria (Codex Alimentarius)

2 Types of criteria Process Hygiene

• Applies in production

• Does not apply to products on the market or imports

• Mainly indicators

• 3 class sampling plan

• Results satisfactory /acceptable /unsatisfactory

• Action :- Improvement in production within HACCP

Food safety

• Applies to products ready to be placed on the market and during their shelf life

• Mainly pathogens

• 2 class sampling plan

• Results satisfactory /unsatisfactory

• Action :- Removal from the market and find the cause within HACCP

Annex I:

1. Chapter 1: Food Safety Criteria

2. Chapter 2: Process Hygiene Criteria

3. Chapter 3: Rules for sampling and preparation of

test samples

Reg. (EC) No 2073/2005 – microbiological criteria

Obligations for the FBO

• demonstrate compliance with MC food safety criteria throughout the shelf-life

durability, challenge studies (Art 3(2), Annex II)

• establish a sampling and testing scheme based on risk (GHP)

• respond in case of non-compliance (Actions GHP)

• follow and assess trends

Obligations for the Competent Authority

• verify that FBO’s comply with rules and criteria

• is entitled to undertake further sampling and analysis

• In the light of results – take any appropriate measures

Conclusions

All EU inistiatives to update the exisiting legislation aims to adress the latest scientific knowledge and experience to ensure that all feed, products of animal and plant origin etc.

produced in the EU meet the highest standards at the same time ensuring broad

variety of choise to adress consumer demands