Food Law and Regulations in the EU Flashcards
Name 6 EU treaties.
- 1951 - Paris
- the EU Coal and Steal Community (ESCS)
- 1957 - Rome
- EEC
- 1986 - Luxemburg and Hague
- Food Initiatives
- 1987 - Maastricht
- EU, Citizenship of the EU, the Euro
- 1999 - Amsterdam
- Reconstructions of CCEE (EUR 6.7 billion)
- 2001 - Nice
- The EU Parliament, Charter of Rights
Describe the treaty of Rome, 1957.
- European Economic Community (EEC)
- France, Netherlands, Belgium, Luxemburg, Italy, and FR Germany (founding members)
- In July 1968, all tariffs among the EEC states were repealed but were established for other countries
- A common market was created (only for members)
- Free movement of food products within this market
- Common agriculture and transport policy
- Protecting revenue for farmers
- Prohibition of monopolies
What was created by the Treaty of Rome?
- A common market
- Free movement of food products
- Common agriculture and transport policy
- Protecting revenue for farmers
- Prohibition of monopolies
- Creation of:
- The EU Commission
- The EU Parliament
- The Court of Justice
European Economic Community (EEC)
Who were the founding members of the EEC? [6]
- France
- Netherlands
- Belgium
- Luxemburg
- Italy
- FR Germany
Describe the initiatives [2] and goals [3] of the Single European Act (1986).
- Signed in Luxemburg and ratified in Hague, came into force in July of 1987.
- Initiatives: Public Health and Food Regulations
- Several objectives for food legislation
- Protect public health
- Ensure fair trading
- setting appropriate labelling standards (Council Directive 90/496/EEC)
- Provide the adequate and necessary official controls of foodstuffs
Describe the Treaty of Maastricht (1992).
- The Treaty of European Union was created and signed (Entry into force November of 1993)
- Food legislation initiatives:
- 1992 - Edinburgh Summit
- Simplification of food legislation, food specifications
- 1993 - General Food Hygiene Directive
- The HACCP system as a generic approach for all sectors of the food system
- Food Industry to develop HACCP models to fit their needs
- 1992 - Edinburgh Summit
Describe the Treaty of Amsterdam, 1997.
“Citizenship of the Union is hereby established. Every person holding the nationality of a Member State shall be a citizen of the Union. Citizenship of the Union shall complement and
not replace national citizenship.”
Describe the Treaty of Nice, 2001.
“Every citizen of the Union shall have the right to move and reside freely within the territory of the Member States, subject to the limitations and conditions laid down in this Treaty and by the measures adopted to give it effect.”
List 5 EU Institutions.
- The Council of EU
- The European Parliament (EP)
- The European Commission (EC)
- The Court of Justice
- To ensure that the law is observed
- The Court of Auditors
- Responsible for auditing the EU budget
Describe the Council of the EU.
- The Council of Ministers (27 Governmental Members; Ministers; 6 months presidency; 2.5-year President of EC)
- One of the two EU legislative chambers
- Divided into several councils
- E.g., Agriculture and Fisheries (food safety, health)
- Legislative and executive power
- Approval of the EC proposals via voting
Describe the European Parliament.
- One of the two legislative branch
- Election, President every 2.5 years
- Legislative, supervisory, and budgetary responsibilities
- Food safety and consumer protection
- Inquiries and public complaints against EU institutions
- EU budgetary authorities (together with the Council)
- 705 seats for Members of the EP
Describe the European Commission.
- The executive body of the EU
- Initiates proposals for legislation and implementation of EU laws
- Ensures that EU legislation is correctly applied by the member states
- Manages and executes EU policies and international trade relations
- Guardian of the Treaties
https://commission.europa.eu/index_en
Describe the diagram of the European Commission.
What is the European Food Safety Authority (EFSA)?
Consultation and advisory role to the European Commission
- Scientific opinions and recommendations
- Development of standards and guidelines
- EFSA established safe sodium and chloride levels (DRV 2.0 g/day; 3.1g for adults, respectively)
- Development of risk assessment procedures
- Examination of risk assessments made by scientists from member states
- Cumulative risk assessment of pesticides (work in progress)
- Cooperation with network and partners
Describe the role of the Directorate General (DG).
Food Safety
- Food and feed safety (biological and chemical safety)
- General food laws and regulations
- Policies; Labelling and nutrition; Novel foods; GMO
- Food fraud; food waste
- Animal and plant health
Public health
- Health policy; healthcare, prevention of diseases
Management of the EU’s Scientific Committees responsible for consumer health
- via EFSA
Health and Food Safety
Describe Regulation (EC) No 178/2002. [3]
- Sets the general principles and requirements of food law
- Outlines procedures for food and feed safety
- Covering all stages of production and distribution
- Established the independent agency: European Food Safety Authority (EFSA)
What is the NDA - Panel on Nutrition, Novel Foods, and Food Allergies?
- Highly qualified experts appointed by EFSA for three years
- Provides opinions and advice related to nutrition, health claims, novel foods, and food safety
Describe the legislative process in the EU.
What are the forms of legislation? [3]
- Directives
- Regulations
- Decisions
What is a directive?
- A directive states compulsory objectives but leaves member states with a certain amount of leeway as to the exact rules to be adopted according to national legislation
- Twelve to eighteen months to come into force
What are regulations?
- Applies directly to all member states, not flexible, must be adopted as soon as issued and published
- Issued by EC, EP, or EC and EP together
What are decisions?
A decision is a law that is not of general application but only applies to its addressee of the decision; Member States, companies, or individuals (e.g., prices of agriculture commodities)
Compare vertical and horizontal forms of legislation.
What is the OJ Publication?
- Official Journal of the EU Communities
- Legislative documents must be published in OJ, to become law
- Series – ‘L’ refers to formally published legislation
- Series – ‘C’ refers to communications, proposals
What are Green and White papers?
Publications by the European Commission
- Green Paper
- Shows proposals
- Stimulates discussion for comments and suggestions
- Determines needs for law, regulations, policy
- White Paper
- Detailed proposals for legislation
- When positively received it moves for approval
What are the purposes of the Green Paper? [5]
-
Public concerns
- Crises over BSE, GMO foods, functional foods
- Major implications for foods safety and health
-
Protection of public health and safety
- Needs for legislation of food law based on risk assessment
- HACCP implementation
- Application of precautionary principle to food safety
- To improve the efficiency and coherence of EU food legislation
- To improve the quality of information to consumers
- Developing an EU-wide nutrition policy
General Principles of Food Law
What is the purpose of the White Paper?
-
Principles of food safety
- From “farm to fork” (the entire food chain) – HACCP, Hygiene
- Standards for the food industry to meet and monitor industry compliance
- Sets limits for contaminants and agriculture residues
- Updates food additives, flavourings, packaging, irradiations
- Traceability for food products
- Establishing effective crisis management and alert systems to control food safety problems
Food Safety
According to Regulation (EC) No 178/2002, define: Food (or foodstuff).
- Any substance or product, whether processed, partially processed, or unprocessed, intended to be, or reasonably expected to be ingested by humans.
- Includes drink, chewing gum, and any substance, including water, intentionally incorporated into the food during its manufacture, preparation, or treatment.
- Food shall not include:
- feed
- live animals unless they are prepared for placing on the market for human consumption
- plants before harvesting
- medicinal products
- cosmetics
- tobacco and tobacco products
- narcotic or psychotropic
- residues and contaminants
What does the definition of food (or foodstuffs) not include? [8]
- feed
- live animals unless they are prepared for placing on the market for human consumption
- plants before harvesting
- medicinal products
- cosmetics
- tobacco and tobacco products
- narcotic or psychotropic
- residues and contaminants
Food (or foodstuff) means any substance or product, whether
processed, partially processed, or unprocessed, intended to be, or
reasonably expected to be ingested by humans. Includes drink, chewing gum, and any substance, including water, intentionally incorporated into the food during its manufacture, preparation, or treatment.
What does the definition of food (or foodstuffs) include? [4]
- Drink
- Chewing gum
- Any substance intentionally incorporated into the food during its manufacture, preparation, or treatment
- Including water
Food (or foodstuff) means any substance or product, whether
processed, partially processed, or unprocessed, intended to be, or
reasonably expected to be ingested by humans.
Discuss titanium dioxide use in the EU.
Colour additive
- Considered unsafe (50% of particles are less than 100 nm)
- Banned by the EU Commission
- Cambridge-based biotech Co. developed white pigment from white beetle to replace titanium dioxide.
Titanium dioxide allowed in the U.S.
List the food additives in the EU. [6]
- Sweeteners
- Colours
- Miscellaneous additives
- Preservatives
- Emulsifiers
- Stabilizers etc.
- Flavourings
Describe the regulations on food additives. [4]
- Definition of food additive
- Food additive categories
- Approval criteria
- Allows member states to prohibit in their country certain classes of additives in the production and sale of traditional foods
- Reinheitsgebot - XY century
Effective in January of 2010
Define food additive.
- Any substance not normally consumed as food in itself.
- Intentionally added to food for a technological purpose
- In the manufacture, processing, preparation, treatment, packaging, transport, or storage of such food results, or may be reasonable to expect to result, in it or its by-products
- And it becomes directly or indirectly a component of such foods
No processing aids (e.g., water completely dissipated during processing)
Substances used as nutrients (e.g., vitamins; minerals) and enzymes in food are not regarded as additives. Enzymes are regarded as addtives in Canada!
To obtain approval, food additives must demonstrate: [3]
Article 6.
- A reasonable technological need and the purpose is not achievable by other practical means
- Benefits to consumers (quality; economical)
-
Safety
- No hazard to the health of the consumer at the propsed use level
- No harmful effects of a food additive or its derivatives
- Toxicological testing and evaluation
- No hazard to the health of the consumer at the propsed use level
All food additives must be kept under continuous observation and be re-evaluated whenever necessary.
All food additives […] and be re-evaluated whenever necessary.
All food additives must be kept under continuous observation and be re-evaluated whenever necessary.
What are provisions for additives? [3]
- Expressions of quantity - maximum level allowed in specific foods (mg/kg; mg/L)
- Quantum satis - no maximum level is specified; additive must be used following GMP at a level not higher than needed; Article 11
- Carry-over principle - it is allowed to use additives that are part of the compound foods (complex ingredients) in some foods (subject to approval or the absence of technological functions in the final product) but not in others (e.g., milk, butter, honey); Article 18
What are labelling requirements for additives?
- Must comply with Regulation EC 1333/2008 (Chapter IV Labelling) and the general labelling
- Additive must be identified by the function, followed by the specific name or E number
- e.g., ‘preservative - sodium benzoate’ or ‘preservative E211’
- Exemption - no need to give E number for modified starches
- e.g., ‘preservative - sodium benzoate’ or ‘preservative E211’
- Additives must be listed in descending order
The number is the same in Codex Alimentarius, and in Australia, but the letter is omitted for Australia and it is ISN for Codex. (i.e., ‘E’ is only used in EU)
What is the exemption to the E number?
No need to give E number for modified starches
What are food additives other than colours and sweeteners?
- preservatives
- anti-oxidants
- emulsifiers
- thickeners
- modified starches
- etc.
Labelling requirements for additives
Where food contains: sweetener(s)
the statement with sweeteners must accompany the name of the product
Labelling requirements for additives
Where food contains: both sugar and sweetener(s)
The statement with sugar and sweeteners must accompany the name of the product
Labelling requirements for additives
Where food contains aspartame
the label must bear the statement contains a source of phenylalanine
Labelling requirements for additives
Where food contains more than 10% of polyols
a label must bear the statement excessive consumption may product a laxative effect
Labelling requirements for additives
Where food contains: GM additives and flavourings.
Must be identified on the label:
- (name of additive) produced from genetically modified source
- genetically modified (name of additive)
- (food additive)* - Footnote to the ingredient list: * Genetically modified
Define: colours.
Substances which add or restore colour in food, and include constituents of foodstuffs and natural sources which are not normally consumed as food as such and not normally used as characteristic ingredients of food.
Describe the Southhampton University studies.
- Indicated that synthetic colours in combination with sodium benzoate are linked to hyperactivity among children
- Mix A consisted of Sunset Yellow (E110), Tartrazine (E102), Carmoisine (E122), Ponceau 4R (E124, Sodium Benzoate (E211)
- Mix B consisted of Sunset Yellow (E110), Quinoline Yellow (E104), Carmoisine (E122), Allura Red (E129), Sodium Benzoate (E211)
- In 2008, the UK Food Standards Agency for a volunatry phase-out of tartrazine, along with five other colours
- In July 2008, the EFSA started evaluation of natural and artificial colours
- Concluded that the findings of McCann et al., could not be used as a basis for altering the ADI of the respective food colours or sodium benzoate.
- EFSA lowers ADI for six artificial colours from 10 mg/kg bw/d to 0.5 -1 mg/kg bw/d)
- including Sunset Yellow, Ponceau 4R, and Quinoline Yellow
- July 2010 – a mandatory warning label for foods containing Southampton colours; “may have an adverse effect on activity and attention in children”
Precautionary principle
Describe the re-evaluation of food additives in the EU.
- Under regulations of EU 257/2010, EFSA must re-evaluate all additives approved before January 20th, 2009.
- So far, they have re-evaluated 70% - more time is needed
Flavouring includes [3]
- Flavouring substances (natural; synthetic)
- Preparations; thermal process (torrefaction; searing; blackening)
- Smoke flavourings; flavour precursors and other flavourings or mixtures
‘Flavouring substance’ means:
- A chemical substance with flavouring properties that is obtained:
- (i)” by physical (including distillation and solvent extraction) or enzymatic or microbiological processes of vegetable or animal material either in the raw or after processing for human consumption by traditional food-preparation processes (including drying, torrefaction, and fermentation)”
- Natural
- (i)” by physical (including distillation and solvent extraction) or enzymatic or microbiological processes of vegetable or animal material either in the raw or after processing for human consumption by traditional food-preparation processes (including drying, torrefaction, and fermentation)”
- (ii) “by chemical synthesis or isolated by chemical processes and which is chemically identical to a substance naturally present in the material of vegetable or animal origin as described in (i),”
- (iii) “by chemical synthesis but which is not chemically identical to a substance naturally present in the material of vegetable or animal origin as described in (i).”
Includes flavouring substances & preparations.
The EU list (community list) of flavourings and source materials (approved by EFSA) for use in and on foods covers: [5]
- Flavouring substances
- Preparations obtained from thermal processing
- Precursors
- Other flavourings
- Flavourings from non-food sources
There are ~2800 flavourings under national legislation.
What are Annex II and III of EC No 1334/2008?
- Annex II: List of traditional food preparation processes
- Annex III Part A: Substances which shall not be added as such to food
- Agaric acid, aloin, capsaicin, coumarin, etc.
- Annex III Part B: Maximum levels of certain substances naturally present in flavourings and food ingredients with flavouring properties
Give examples of substances from Annex III Part A. [4]
- Agaric acid
- Aloin
- Capsaicin
- Coumarin
Substances which shall not be added as such to food
Describe the Food Information Regulation. [4]
- Mandatory nutrition information on processed foods
- Mandatory labelling of ‘the country of origin’ for:
- Unprocessed foods including pork, meat from sheep, goats, and poultry
- Milk and milk ingredients
- Highlighting allergens
- Using the font, style, or background colour
- e.g., peanuts or milk in the list of ingredients
- Using the font, style, or background colour
- Mandatory allergens indicated on prepackaged foods, including those sold in restaurants and cafes
Describe miscellaneous labelling rules.
Geographical indications
- Food producers and suppliers can register their labels with the appropriate authorities to be recognized throughout the EU and protect their original food formulations
Developed to protect traditional foods.
Describe how the name of the food must appear on a label.
- If the name is described in EU legislation, this name should be used
- If there are no EU names:
- A legal name prescribed in the member state (no trademark or brand)
- A customary name or descriptive name that is clear for the consumer, reflecting the true nature of the food
- If the food has been treated (dried, frozen, etc.) this should be reflected in the food name.
Describe the list of ingredients requirements.
- Descending order
- Ingredients that are less than 2% of the finished product may be listed in a different order after the other ingredients
- Ingredient function followed by name or E number
- An ingredient list is not required for beverages containing 1.2% alcohol by volume
- Compound ingredients; the 2% rule
What is the 2% rule?
- Components of compound ingredients that form less than 2% of the final product may be included in the list of ingredients but are not mandatory
- It is based on the principle that the consumer knows the composition of compound ingredients and can therefore deduce, for example, that jam added to biscuits is prepared with fruit and sugar.
- This provision does not apply to additives
What is the QUID and when is it required?
- The Quantitative Ingredients Declaration
- If an ingredient is part of the food name
- If it is emphasized by pictures or words
- If it is essential to characterize the food
- Its quantity must be declared in the ingredients list
Give some examples of QUID.
The Quantitative Ingredients Declaration
What are the net quantity requirements?
- Metric units of volume (for liquid)
- Metric units of mass (for other products)
- Nominal weight (volume) must be shown on the package’ the small letter ‘e’ must be placed to net quantity as an indicatory that the content is not less than declared
Serving sizes: no specific requirements
Describe the minimum durability labelling requirements.
- Best before - for products with a shelf-life of three months or less
- Use by - for foods that are microbiologically highly perishable
What is the list of allergens in EU? [14]
Directive 2003/89/EC Annex IIIa
- Cereals containing gluten ( i.e. wheat, rye, barley, oats, spelt, kamut or their hybridised strains) and products thereof
- Crustaceans and products thereof
- Eggs and products thereof
- Fish and products thereof
- Milk and products thereof (including lactose)
- Peanuts and products thereof
- Soybeans and products thereof
- Nuts (i.e. Almond, Hazelnut, Walnut, Cashew, Pecan nut, Brazil nut, Pistachio nut, Macadamia nut) and products thereof
- Celery and products thereof (not an allergen in Canada)
- Mustard and products thereof (not an allergen in the USA)
- Sesame seeds and products thereof
- Sulphur dioxide and sulphites > 10 mg/kg or 10 mg/l expressed as SO2
- Lupin and products thereof
- Mollusks and products thereof
When should Nutrition and Health Claim Regulations (NHCR) apply? [4]
- This regulation should apply to all nutrients and health claims made on/in:
- Label and labelling
- Commercial communications
- Generic advertising of food
- Promotional campaigns
Define: health claim
- It means any claim that states, suggests, or implies that a relationship exists between a food category, a food or one of its constituents and health.
- Including pictorial, graphic, or symbolic representation
Describe claim substantiation.
- Based on Codex Alimentarius and PASCLAIM (abbreviation of journal name where results were published - i.e., which biomarkers can be used to substantiate health claims)
Disease risk reduction claims require, in addition to being based on human data: […]
- Additional data from intervention, randomized, double-blind, placebo-controlled trials
The use of nutrition and health claims shall not: [5]
- Be false, ambiguous, or misleading
- Give rise to doubt about the safety and/or the nutritional adequacy of other foods
- Encourage or condone excess consumption of food
- State, suggest, or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general
- Refer to changes in bodily functions which could give rise to or exploit fear in the consumer
Describe energy claims.
Energy Free: Canada/USA <5 kcal/serving size
Note that if you translate to serving size the amounts are not comparable to USA/Canada.
Describe fat claims.
Fat free is same for USA and Canada but for serving size
1.
Describe sodium claims.
Sodium Free: Canada and USA less; 5mg/serving size for 30g or more
Must convert this to values from sodium to salt using molecular weight.
Describe sugar claims.
Describe fiber and protein claims.
High Source: Canada -food contains 4 g or
more of fibre per reference amount and
serving of stated size while USA - 5g or more
Describe vitamin and mineral claims.
Canada: Source 5%; Good source 15%; Excellent source 25% of DV
(Except for Vitamin C, then it is 30 and 50% for good and excellent, respectively)
Which vitamins and minerals may be declared?
What are the categories of EU Health Claims?
How many health claims are allowed in EU?
- 241 are granted under article 13 (6 with proprietary protection)
- 28 granted under article 14
Why did EFSA reject 400 probiotic health claim dossiers under article 13?
- Lack of convincing evidence
- For human health and well-being
- For reducing the content of pathogenic microorganisms
Give an example of an authorized health claim with lactic acid bacteria by EU.
- “Live cultures in yoghurt or fermented milk improve lactose digestion of the product in individuals who have difficulty digesting lactose”
- Conditions: food must contain minimum 108 CFU of L. delbrueckii subsp. bulgaricus and S. thermophilous per gram
- Art. 13(1) – Live yoghurt culture
What did the Spanish Agency approve in November of 2020?
- The term ‘probiotic’ on foods and dietary supplements.
Describe approved weight management claims.
- EFSA approved health claims on meal replacements (Unilever product ‘Slim-Fast’)
- Reduction of body weight
- Maintenance of body weight after weight loss
Describe the Konjac Glucomannan weight reduction claim.
“To obtain the claimed effect, at least
3 g of glucomannan should be
consumed daily in three doses of at
least 1 g each, together with 1-2
glasses of water before meals, in the
context of an energy-restricted diet.
The target population is overweight
adults.”
Dietary fiber.
The product presents a choking hazard if not consumed with adequate water.
What is the permitted sterol health claim?
- Plant sterols have been shown to lower/reduce blood
cholesterol. - Blood cholesterol lowering may reduce the risk of coronary heart disease
- Qualifying dose: 2.0 g/day
Describe the labelling requirements of GMO foods.
- The following statement shall appear in the list of ingredients:
- ‘genetically modified’ or ‘produced from genetically modified (name of the ingredient)’ - for more than one ingredients
- ‘contains genetically modified (name of organism)’ or ‘contains (name of ingredient) produced from genetically modified (name of organism)’ – for one ingredient
Describe the traceability and labelling of GMO foods. [3]
What are the objectives? [2]
- Requires all member states to ensure traceability and accurate labelling of authorized GM foods at all stages
of their placing on the market - Requires all documentation to account for identifying GM products throughout the supply chain
- The record must be kept by operators for 5 years, including information about suppliers and distributors (retailers)
Define: Organic [3]
- At least 95% of the product’s ingredients of agricultural origin have been organically produced;
- The product complies with the rules of the official inspection scheme;
- The product bears the words “organic certification” followed by the code of the inspection body (EU Organic Standards)
What is a quantitative declaration?
- QUID stands for Quantitative Ingredient Declaration.
- In certain circumstances, it is necessary to state on the label the quantity, in percentage terms, of an ingredient or category of ingredients used in the manufacture or preparation of a foodstuff.
Describe nutrition labelling in EU.
- Started December of 2016 - nutrition labelling is mandatory
- Nutrition information shall be included in the following order:
- Energy
- Fat
- Saturated fat
- Carbohydrate
- Sugars
- Protein
- Salt
How must nutrient quantities and energy values be expressed?
- The nutrient quantities and energy values must be expressed per 100 grams or 100 ml of the product and may also be expressed per serving or portion of the product
- The quantities of vitamins and minerals must be given not only per 100 g/ml but also as a % of the Population Reference Intake (RI)
There is no mandatory requirement for serving sizes!
What are novel foods in EU?
- Foods and ingredients that have not been “previously used to a significant degree for human consumption” within the EU before May 15, 1997 (e.g. functional foods)
- A food that has been manufactured, prepared, preserved or packaged by a process that
- has not been previously applied to that food,
- and cause the food to undergo a major change
- Faster process for a traditional foods from third countries (a notification)
- Data protection for up to 5 years
- Novel food catalogue
What are EU Regulations on insect foods?
Novel foods
- The EU Commission, based on the EFSA recommendation, approved four insect species (frozen, paste, dried, and powder) as novel foods to be used in snacks, bakery products, other food products, whey powder, food supplements, and food ingredients for human consumption and marketing:
Describe new novel foods authorization.
Give 4 examples of approved novel foods by EU commission.
- Sterol esters for use in yellow fat spread (Unilever Co., 2000)
- DHA-rich oil derived from microalgae Schiochytrium (Martek Biosciences Co., 2003)
- Noni juice, and powder from Indian mulberry (Morinda citrifolia) (Morinda Co., 2003), (Oy Foodfiles Ltd. 2012)
- Argan Oil (Le Bio-Monde, 2010), (El Kheir, 2014)
What are the four approved insect species?
- Migratory locust
- Yellow mealworm
- House cricket
- Lesser mealworm
