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The EU rules on

Contaminants and Food

Improvement Agents Patrick DeboyserProfessor - European College of Parma

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Regulation (EC) 178/2002General Food Law

EFSARASFF

Food informationto consumers

Quality of productsParticular nutritional needs

Plant HealthAnimal HealthAnimal Welfare

Food safetyOfficial controlsImport regimeHygiene rules

EU Food Law

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EU Food Law

Food improvement agentso Additiveso Flavouringso Enzymes

Residueso Pesticideso Veterinary medicineso Hormones

Contaminantso Mycotoxinso Heavy metalso Dioxin and PCBs

Microbiological criteriao Listeriao Campylobactero Salmonella

Food Safety

Food contact materialso Plastic materialso Ceramics/Celluloseo Paper/Inks/Metals

Processeso Novel foodo GM foodo Irradiationo Radioactive contamination

Animal nutritiono Feed materialso Feed additiveso Compound feed including pet foodo Medicated feed

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EU Rules on Food Improvement Agents

What are Food improvement agents?

Food improvement agents are substances which are added to food or used in the production of food with a specific purpose in mind.

They are subject to a common legislative framework:

Regulation (EC) No 1331/2008 on the common authorization procedure

Regulation (EC) No 1332/2008 on enzymes

Regulation (EC) No 1333/2008 on additives

Regulation (EC) No 1334/2008 on flavourings

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

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EU Rules on Food Improvement Agents

EU Rules on Additives

Additives can be used for various purposes. EU legislation defines 26 "technological purposes“, such as: Colours, which are used to add or restore colour in a food Preservatives, added to prolong the shelf-life of

foods by protecting them against micro-organisms Antioxidants, which prolong the shelf-life of foods

by protecting them against oxidation

All additives in the EU must be authorized and listed with conditions of use in the EU's positive list based on: a safety assessment the technological need ensuring that use of the additive will not mislead consumers

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

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EU Rules on Food Improvement Agents

EU Rules on Additives

Legislation: Regulation (EC) No 1333/2008 of the European Parliament and of the Council

of 16 December 2008 on food additives

Consolidated text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:02008R1333-20160525

Guidance (Q&A): http://europa.eu/rapid/press-release_MEMO-11-783_en.htm

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

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EU Rules on Food Improvement Agents

EU Database on food additivesFOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

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EU Rules on Food Improvement Agents

EU Database on food additivesFOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

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EU Rules on Food Improvement Agents

EU Database on food additivesFOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

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EU Rules on Food Improvement Agents

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

Re-evaluation program

Food additives permitted before 20 January 2009 must go through a new risk assessment by the European Food Safety Authority (EFSA).

State of play of the re-evaluation of safety of permitted food additives by EFSA as of 20 July 2018:

316 additives approved before 20 January 2009 to be re-evaluated by EFSA

104 scientific opinions published by EFSA on the re-evaluation of the safety of food additives, covering 175 individual additives

141 additives still to be re-evaluated by EFSA before 31 December 2020.

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EU Rules on Food Improvement Agents

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

EU rules on flavourings

Flavourings are products added to food in order to impart or modify the odour and/or taste of food. They are used in comparatively small amounts so that consumer exposure is relatively low.

EU legislation defines several types of flavourings such as flavouring substances flavouring preparations smoke flavourings

The legislation: lays down general requirements for safe use of flavourings sets out substances for which an evaluation and approval is required lists the substances which have been approved

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EU Rules on Food Improvement Agents

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

EU rules on flavourings

Legislation: Regulation (EC) No 1334/2008 of the European Parliament and of the Council of

16 December 2008 on flavourings and certain food ingredients with flavouringproperties for use in and on foods

Consolidated text: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32008R1334

Guidance (EFSA): https://efsa.onlinelibrary.wiley.com/doi/pdf/10.2903/j.efsa.2010.1623

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EU Rules on Food Improvement Agents

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

EU Database on flavourings

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EU Rules on Food Improvement Agents

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

EU rules on enzymes

Enzymes are naturally-occurring proteins that enhance biochemical reactions. They can be obtained by extraction from plants or animals or by fermentation

from micro-organisms. They are normally added to perform a technological function in the

manufacture, processing, preparation or treatment of foods.

Industry had [3,5] years to submit applications for authorization of the enzymes they wish to use in food. These applications are in the process of being evaluated for safety by EFSA.

Only the enzymes for which the proposed uses are considered safewill be on the EU list.

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EU Rules on Food Improvement Agents

FOODIMPROVEMENT

AGENTS

ADDITIVES

FLAVOURINGS

ENZYMES

EU rules on flavourings

Legislation: Regulation (EC) No 1332/2008 of the European Parliament and of the Council of

16 December 2008 on food enzymes

Consolidated text: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32008R1332

Guidance (Commission): https://ec.europa.eu/food/sites/food/files/safety/docs/fs_food-improvement-

agents_enzymes-guidance-categorisation.pdf

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EU Rules on Contaminants

EU rules on contaminants

Contaminants are substances that have not been intentionally added to food. These substances may be present in food as a result of: the various stages of its production, packaging, transport or holding;

environmental contamination.

EU rules on contaminants do not cover: pesticide residues

veterinary drug residues

food contact materials

as these are subject to dedicated provisions of EU legislation.

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

EU rules on contaminants

Legislation: Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community

procedures for contaminants in food

Consolidated text: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A31993R0315

Guidance: https://ec.europa.eu/food/sites/food/files/safety/docs/cs_contaminants_factsh

eet_en.pdf

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

Basic principles :

A high level of protection of human health has to be pursued.

Food compliant with EU legislation should benefit from the free movement of goods within the European.

International standards have to be taken into account

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

How to achieve a high level of public health?

Food containing a contaminant to an amount unacceptable from the public health viewpoint, shall not be placed on the market.

Contaminant levels shall be kept as low as can reasonably be achieved (ALARA) following recommended good working practices.

Maximum levels must be set for certain contaminants.

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

Risk assessment:

Hazard characterization: risks related to the presence of a contaminant in foodstuffs for human health

establishment of a tolerable intake

health based guidance value

Exposure assessment: human exposure (average and 95 percentile)

particular attention paid to vulnerable groups of population and high level consumers

Risk characterization: human exposure assessed in relation to the health based guidance value

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

Risk management:

Determination of foods/food groups significantly contributing to the exposure Food groups with frequent findings of high level of contamination

Occurrence data of the contaminant/mycotoxin in the various food/food groups

Setting a maximum level following the ALARA principle (As Low As Reasonably Achievable). The degree of severity of the application of this principle depends on the relation exposure/tolerable intake

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

Maximum levels of contaminants: legislation

Legislation: Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting

maximum levels for certain contaminants in foodstuffs

Consolidated text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1881-

20150731

Guidance (Sampling and Analysis): https://ec.europa.eu/food/sites/food/files/safety/docs/cs_contaminants_sampli

ng_analysis-guidance-2010_en.pdf

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EU Rules on Contaminants

Maximum levels of contaminants: which food?

Contaminant FoodNitrate Vegetables, Infant food

Aflatoxin Nuts, Groundnuts, Dried fruits, Cereals

Ochratoxin A Cereals, Coffee, Vine fruit, Wine

Lead Cereals, Dairy, Fats/Oils, Meat/Offal, Fish/Shellfish,

Fruits, Vegetables, Infant food, Alcoholic beverages

Cadmium Cereals, Meat/Offal, Fish/Shellfish, Vegetables

Mercury Fish/Shellfish

Tin Infant food, Canned food/beverages

Benzo(a)Pyrene Fats/Oils, Meat/Offal, Fish/Shellfish, Infant food

Dioxins Dairy, Eggs, Fats/Oils, Meat/Offal, Fish/Shellfish

3-MCPD Condiments, Other

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

Maximum levels of contaminants: sampling and analysis

Provisions for the sampling and analysis for the official control of the maximum levels are laid down as follows:

Contaminant Food

Nitrates Commission Regulation (EC) 1882/2006

Mycotoxins Commission Regulation (EC) 401/2006

Heavy metals Commission Regulation (EC) No 333/2007

Lead Commission Regulation (EU) 2017/644

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

Maximum levels of contaminants: official controls

Member States authorities are responsible for sampling food products and analyzing them, to ensure that they comply with the legislation.

For imported foodstuffs: the country of origin is responsible for compliance with EU legislation and this is controlled at EU borders and on the market.

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

Workable rules

Where maximum limits are fixed, they should be fixed at a level reasonably achievable, but stimulating a preventive approach.

Sampling procedures should be

Adequate for estimating lot average levels in case contaminants are heterogeneously distributed throughout a lot (as is the case for aflatoxins and ochratoxin A)

Practicable in order to minimize the consumer’s risk without rendering trade impossible

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

EU strategy to reduce the health impact of contaminants

Invest more in prevention

Risk management tools: maximum levels, action levels, target levels,

source-directed measures,

encouraging GAP, GMP, GSP (Good Storage Practices)

EU measures to reduce the contaminant level in food: determined on a case by case basis (dependent of the nature of the

contaminant),

can be a combination of several approaches into one strategy.

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

Examples (of choice/combination of approaches)

Maximum levels: aflatoxins, ochratoxin A, lead, cadmium, 3-MCPD,inorganic tin, citrinin

Maximum levels with regional derogations: dioxins

Maximum levels combined with code of practice for prevention and reduction: patulin, Fusarium-toxins

Maximum levels combined with dietary advice: mercury

Code of practice: ethylcarbamate

Data collection: acrylamide, furan…

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Rules on Contaminants

Challenges

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

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

Need to update risk assessments: cadmium, mercury, ochratoxin A, lead…

Risk-benefit assessment: nitrates in vegetables

Emerging contaminants: Brominated flame retardants, 3-MCPD esters…

Changing production conditions/climate change: mycotoxins, phytotoxins…

CONTAMINANTS

BASICPRINCIPLES

MAXIMUMLEVELS

TRENDS &CHALLENGES

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EU Food Law

Food improvement agentso Additiveso Flavouringso Enzymes

Residueso Pesticideso Veterinary medicineso Hormones

Contaminantso Mycotoxinso Heavy metalso Dioxin and PCBs

Microbiological criteriao Listeriao Campylobactero Salmonella

Food Safety

Food contact materialso Plastic materialso Ceramics/Celluloseo Paper/Inks/Metals

Processeso Novel foodo GM foodo Irradiationo Radioactive contamination

Animal nutritiono Feed materialso Feed additiveso Compound feed including pet foodo Medicated feed

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Thank you!