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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!
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