Contaminants and Microbiological criteriaseminar2019india.eu/brochures/d2/Topics 6 (c) COULON The EU management system for...Dr S.COULON DG SANTE - Desk Officer India –Unit D3 International

Dr S.COULON

DG SANTE - Desk Officer India – Unit D3 International Bilateral Relations

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 life cycle of a PPP

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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

"Approval" vs. "Authorisation"

Separation risk assessment / risk management

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Industry

1 Member State (RMS)

European Food SafetyAuthority (EFSA) + all Member States

EFSA

Commission+ all Member States

Data dossier

Draft Assessment Report (DAR)

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 (RMS)• 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

• But 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 taking into account progress in

scientific and technical knowledge and changes in legal requirements

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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 criticalGood 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 the EU

• Transparency and predictability aspects

• 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 tolerancerequest

Review of existing MRLs

Codex MRLs

Regulationsetting,

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 EFSAEMS/RMS

SC PAFF(28 MS)

COM

Council& EP

MRLCOM

dossier ER RO

draft act

vote scrutiny adoption

≈ 1 year 3-6 months

≈ 3 months

1-2 months < 1 month2 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/comments

Evidence on the impact on trade

• Interviews

• In the framework of the case studies

Haloxyfop in lin seed from Russia and Kazakhstan

Sulfoxaflor in citrus fruit from South Africa, Turkey and Chile

Thiabendazole in sweet potatoes and mangoes from the US and Brazil….

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Cut-off CriteriaCriteria 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 disruptors (ED) …

• Limited derogation possibilities for some of these criteria are provided

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)

MORE 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.?)

Import tolerances and Codex Maximum Residue Limits

New MRLs established based on

• GAPs in the 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 the EU and Third Countries:

same MRLs for all food and feed on the EU market

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 toconsumers (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 the 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

• Others

Unavoidable carry over of coccidiostats in non-target feed

Residues of biocides (not elsewhere covered)

Framework Regulation 315/93Provisions

• General provision:

food containing a contaminant in an amount which isunacceptable from the public health viewpoint and inparticular at a toxicological level shall not be placed on themarket

• Good practice:

contaminant levels shall be kept as low as can reasonablybe achieved following good practices at all stages (ALARAprinciple)

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Framework Regulation 315/93Provisions

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.

“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 themaximum levels (taking into account the measurement uncertainty) shall not beplaced 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 takinginto account the toxicity for humans, sensitivity of different animal species. Someflexibility possible in enforcement.

Mycotoxins: Need for a comprehensivestrategy: 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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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, inorganicarsenic, …

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

• Developments in risk assessment approaches Risk-benefit assessment: nitrates in vegetablesMargin of Exposure (MOE): genotoxic carcinogens such as aflatoxins,

PAH

Driving forces for initiating new EU-legislation on contaminants

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

• Changing production conditions/ climate change: Mycotoxins, phycotoxins,

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

• Identified problems with current legislation

Safeguard measuresCommission 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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Microbiological hazardsand EU food law

EU food law - microbiological hazards: preventive approach

Reg. 178/2002*Reg. 852/2004*Reg. 853/2004Reg. 854/2004

Reg. 882/2004*

Reg. 2073/2005*…

Reg. 2160/2003Control salmonellaand other specified zoonotic agents National Control Programmes (NCP’s) and targets

Directive 2003/99Monitoring

and reporting Zoonotic agents

Foodborne outbreaksAMR

Food Hygiene Legislation Zoonoses Regulation

Zoonoses Directive

Reg.183/2005Feedstuffs

*FNAO

To ensure a high level of human health protection

To harmonise microbiological criteria

Uniform rules for food business operators

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

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

EU food law - microbiological hazards: preventive approach

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

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 (indicators of hygiene)

Improvement of production hygiene chain

Selection of raw materials

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

Persistent failure = ineffective FSMS

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

Obligations for the FBO/CAs

• demonstrate compliance with MC

food safety criteria throughoutthe shelf-life

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

• establish a sampling and testingscheme

based on risk (GHP)

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

• follow and assess trends

• verify that FBO’s comply withrules and criteria

• is entitled to undertake further sampling and analysis

• In the light of results – take any appropriate measures

Strengths of the EU system

EU system very open and transparent

Based on scientific assessment made by EFSA

The EU systematically takes over Codex MRLs into the EU-MRL legislation, unless there are health concerns.

The EU participed actively in international debates,

Robust and harmonised food safety management system appliedthroughout all the EU MS

Lesson-learnt from sanitary risis to improve legislation

Many useful tools like RASFF and Traces to identify the traceabilty of all food products and to be able to trace location, to seize and to recallthem