Food Law and Regulations in the EU Flashcards
1
Q
Name 6 EU treaties.
A
- 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
2
Q
Describe the treaty of Rome, 1957.
A
- 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- In July 1968, all tariffs among the EEC states were repealed but were established for other countries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
3
Q
What was created by the Treaty of Rome?
A
- 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)
4
Q
Who were the founding members of the EEC? [6]
A
- France
- Netherlands
- Belgium
- Luxemburg
- Italy
- FR Germany
5
Q
Describe the initiatives [2] and goals [3] of the Single European Act (1986).
A
- 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
6
Q
Describe the Treaty of Maastricht (1992).
A
- 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
7
Q
Describe the Treaty of Amsterdam, 1997.
A
“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.”
8
Q
Describe the Treaty of Nice, 2001.
A
“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.”
9
Q
List 5 EU Institutions.
A
- 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
10
Q
Describe the Council of the EU.
A
- 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
11
Q
Describe the European Parliament.
A
- 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
12
Q
Describe the European Commission.
A
- 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
13
Q
Describe the diagram of the European Commission.
A
14
Q
What is the European Food Safety Authority (EFSA)?
A
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
15
Q
Describe the role of the Directorate General (DG).
A
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
16
Q
Describe Regulation (EC) No 178/2002. [3]
A
- 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)
17
Q
What is the NDA - Panel on Nutrition, Novel Foods, and Food Allergies?
A
- Highly qualified experts appointed by EFSA for three years
- Provides opinions and advice related to nutrition, health claims, novel foods, and food safety
18
Q
Describe the legislative process in the EU.
A
19
Q
What are the forms of legislation? [3]
A
- Directives
- Regulations
- Decisions
20
Q
What is a directive?
A
- 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
21
Q
What are regulations?
A
- 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
22
Q
What are decisions?
A
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)
23
Q
Compare vertical and horizontal forms of legislation.
A
24
Q
What is the OJ Publication?
A
- 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
25
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
26
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**
## Footnote
General Principles of Food Law
27
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**
## Footnote
Food Safety
28
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
29
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
## Footnote
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.
30
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
## Footnote
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.
31
Discuss titanium dioxide use in the EU.
## Footnote
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.
## Footnote
Titanium dioxide allowed in the U.S.
32
List the food additives in the EU. [6]
* Sweeteners
* Colours
* Miscellaneous additives
* Preservatives
* Emulsifiers
* Stabilizers etc.
* Flavourings
33
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
## Footnote
Effective in January of 2010
34
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)
## Footnote
Substances used as nutrients (e.g., vitamins; minerals) and enzymes in food are not regarded as additives. Enzymes are regarded as addtives in Canada!
35
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
## Footnote
All food additives **must be kept under continuous observation** and be re-evaluated whenever necessary.
36
All food additives **[...]** and be re-evaluated whenever necessary.
All food additives **must be kept under continuous observation** and be re-evaluated whenever necessary.
37
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
38
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
* Additives must be listed in descending order
## Footnote
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)
39
What is the exemption to the E number?
No need to give E number for modified starches
40
What are food additives other than colours and sweeteners?
* preservatives
* anti-oxidants
* emulsifiers
* thickeners
* modified starches
* etc.
41
# Labelling requirements for additives
Where food contains: sweetener(s)
the statement **with sweeteners** must accompany the name of the product
42
# 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
43
# Labelling requirements for additives
Where food contains aspartame
the label must bear the statement **contains a source of phenylalanine**
44
# 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**
45
# 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
46
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.
47
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**
48
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
49
Flavouring includes [3]
* Flavouring substances (natural; synthetic)
* Preparations; thermal process (torrefaction; searing; blackening)
* Smoke flavourings; flavour precursors and other flavourings or mixtures
50
'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
* (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).”
## Footnote
Includes flavouring substances & preparations.
51
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.
52
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
53
Give examples of substances from Annex III Part A. [4]
* Agaric acid
* Aloin
* Capsaicin
* Coumarin
## Footnote
Substances which shall not be added as such to food
54
Describe labelling of flavourings.
## Footnote
Rules for labelling are set by EC 1334/2008 (Chapter IV)
* Flavouring may be labelled under:
* Category name as 'flavouring' or
* Specific name, e.g., vanillin
* Caffeine and quinine must be labelled with the specific name
* When labelled as natural - a source must be indicated
* e.g., natural strawberry flavouring
* at least 95% of flavouring must be natural
55
What are basic food labelling rules? [3]
* Labelling **applies to all pre-packaged foods** delivered to consumers either at retail or the catering establishments
* The labelling and advertising should **not be misleading**
* **No medicinal claims** are allowed
56
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
* Mandatory allergens indicated on prepackaged foods, including those sold in restaurants and cafes
57
What information must appear on the label? [11]
* The name of the food
* The list of ingredients
* The quantity of certain ingredients
* The net quantity
* The date of minimum durability
* Nutrition declaration
* Any special storage conditions or conditions of use
* The name and address of the manufacturer, packager, or seller
* Place of origin, if the omission of such information would mislead
* Any instructions for use
* Alcoholic strength by volume for beverages containing more than 1.2% alcohol
58
Describe miscellaneous labelling rules.
## Footnote
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**
## Footnote
Developed to protect traditional foods.
59
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.
60
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
61
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**
62
The 2% rule applies to additives.
True or False?
False.
63
The 2% rule does not apply to additives.
True or False?
True.
64
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
65
Give some examples of QUID.
| The Quantitative Ingredients Declaration
66
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
## Footnote
Serving sizes: no specific requirements
67
There are no specific serving size requirements in the EU.
True or False?
True.
68
There are specific serving size requirements in the EU.
True or False?
False.
There are no specific serving size requirements in the EU.
69
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
70
What **must** be labelled with the specific name? [2]
**Caffeine and quinine** must be labelled with the specific name.
71
Describe allergen declarations.
## Footnote
Directive 2003/89/EC and Regulation1169/2011
* Substances or products causing allergies or intolerances must be declared on a label of:
* food products and alcoholic beverages
72
What is the list of allergens in EU? [14]
## Footnote
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
73
Define GMO.
* means a genetically modified organism in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination
* Excluding organisms obtained through (Annex IB)
* Mutagenesis
* Cell fusion of plant cells of organisms which can exchange genetic material through traditional breeding methods
| Must immortalize cells - use cancer cells!!
74
What organisms are excluded from the definition of GMOs? [2]
* Excluding organisms obtained through (Annex IB):
* Mutagenesis
* Cell fusion of plant cells of organisms which can exchange genetic material through traditional breeding methods
75
Labelling of GMO foods apply to foods that [2]
* Contain GMOs
* Produced from or contain ingredients from GMOs
76
Labelling of GMO foods is not required when:
Food that contains less than 0.9% GMOs (e.g. ingredients) that are used for technical reasons or adventitious.
## Footnote
Must be demonstrated to be adventitious or technically unavoidable.
77
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
78
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
79
Define: nutrition claims.
* It means any representation and any advertising message that states, suggests, or implies that a foodstuff has nutrition properties due to:
* The energy (calorific value) it
* Provides
* Provides at a reduced or increased rate or
* Does not provide
* The nutrients it
* Contains
* Contains in reduced or increased proportions or
* Does not contain
80
What are Nutrition and Health Claims General Principles?
* Claims on foods must be understood by the consumer (i.e., not misleading)
* Health claims should be **scientifically substantiated**:
* by the totality of the available scientific data
* by weighing the evidence
* should only be authorized for use after a scientific assessment... by the European Food Safety Authority
81
Describe claim substantiation triangle.
* 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)
82
Scientific substantiation of function claims should be [...]
Based on human data (observational and/or intervention studies)
83
Disease risk reduction claims require, in addition to being based on human data: [...]
* Additional data from intervention, randomized, double-blind, placebo-controlled trials
84
Studies required for substantiation of claims should be: [3]
* Conducted using **whole functional foods** (preferably)
* Relevant to the intended claim and **target population**
* **Statistical power** to test the hypothesis and clinical meaningfulness should be considered
85
Describe considerations of the food matrix for studies aimed to substantiate claims. [3]
* Food and its components **must be characterized**
* An amount of food or dose of food component used should be **consistent with its intended pattern of consumption**
* The **effect of the food matrix and dietary context on the functional effect** of the component should be considered
86
Describe considerations of the 'markers' for studies intended to substantiate claims. [4]
* The claimed functional benefit should be **measured directly** if possible
* In situations when this is not possible, appropriate biomarker(s) as intermediate endpoints should be identified and used in the studies
* In disease risk reduction claims, the biomarker(s) considered should be a **marker(s) of that disease** and recognized by the scientific community
* Methodology for measuring the biomarker(s) should be generally accepted by the international scientific community relative to that discipline
## Footnote
An example of a direct measurement is death!
87
List the first set of EFSA questions during the process of evaluation of a health claim application. [3]
* Is the food/bioactive sufficiently characterized?
* Is the claimed effect beneficial to human health?
* Is the cause-and-effect relationship established?
## Footnote
Fail one = fail all
88
Describe the second set of EFSA questions during the process of evaluation of a health claim application. [5]
* Is the mode of action plausible?
* Is the quantity of food consumption (dose) adequate?
* Does the claim wording reflect the scientific evidence?
* Dose the claim wording comply with the regulations?
* Are the conditions of use appropriate?
89
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
90
Describe energy claims.
Energy Free: Canada/USA <5 kcal/serving size
## Footnote
Note that if you translate to serving size the amounts are not comparable to USA/Canada.
91
Describe fat claims.
Fat free is same for USA and Canada but for serving size
92
What are the requirements to make a 'Source of Omega-3 Fatty acids' claim?
* the product contains at least 0.3 g alpha-linolenic acid per 100 g and 100 kcal, or at least 40 mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal
93
What are the requirements to make a 'high omega-3 fatty acid' claim?
– the product contains at least 0.6 g alpha-linolenic acid per 100 g and 100 kcal, or at least 80 mg of the sum of eicosapentaenoic acid and docosahexaenoic acid per 100 g and per 100 kcal.
94
What are the requirements to make a 'high monounsaturated fat' claim?
the product contains at least 45 % of the fatty acids derived from monounsaturated fat, which must provide more than 20% of the product’s energy.
95
What are the requirements to make a 'high polyunsaturated fat' claim?
the product contains at least 45 % of the fatty acids derived from polyunsaturated fat, which must provide more than 20% of the product’s energy.
96
What are the requirements to make a 'high unsaturated fat' claim?
the product contains at least 70 % of the fatty acids derived from unsaturated fat, which must provide more than 20 % of the product’s energy.
97
# 1.
Describe sodium claims.
Sodium Free: Canada and USA less; 5mg/serving size for 30g or more
## Footnote
Must convert this to values from sodium to salt using molecular weight.
98
Describe sugar claims.
99
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
100
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)
101
Which vitamins and minerals may be declared?
102
Describe the 'increased [name of nutrient]' claim requirement.
A claim stating that the content in one or more nutrients, other than vitamins and minerals, has been increased, and may only be made where the product meets the conditions for the claim ‘source of’ and the increase in content is at least 30 % compared to a similar product.
## Footnote
Solids per 100 g | Liquids per 100 mL
103
Describe the 'reduced [name of nutrient]' claim requirements.
A claim stating that the content in one or more nutrients has been reduced and may only be made where the reduction in content is at least 30 % compared to a similar product, except for micronutrients, where a 10 % difference in the reference values as set in Directive 90/496/EEC shall be acceptable, and for sodium, or the equivalent value for salt, where a 25 % difference shall be acceptable.
## Footnote
Solids per 100 g | Liquids per 100 mL
104
Describe the light/lite claim requirements.
A claim stating that a product is ‘light’ or ‘lite’ and shall follow the same conditions as those set for the term ‘reduced’; the claim shall also be accompanied by an indication of the characteristic(s) which make(s) the food ‘light’ or ‘lite’.
## Footnote
Solids per 100 g | Liquids per 100 mL
105
Describe the 'naturally/natural' claim requirements.
Where a food naturally meets the condition(s) of Reg
1924/2006 (Annex) for the use of a nutritional claim, the term ‘naturally/natural’ may be used as a prefix to the claim.
106
What are the categories of EU Health Claims?
107
List the health claims made on food.
* General health claims
* Role of a nutrient or other substance in growth, development, and the functions of the body
* Referring to psychological and behavioral functions
* **Slimming or weight-control**
* Cognitive performance (e.g., DHA)
* Disease risk reduction claims
* Claims referring to children's development and health
## Footnote
Weight-control claim is unique to EU.
108
How many health claims are allowed in EU?
* 241 are granted under article 13 (6 with proprietary protection)
* 28 granted under article 14
109
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
110
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
111
What did the Spanish Agency approve in November of 2020?
* The term 'probiotic' on foods and dietary supplements.
112
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
113
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.
## Footnote
The product presents a choking hazard if not consumed with adequate water.
114
What was the heart health claim and sterol esters approved based on?
* human data submitted by Unilever that substantiated the claim:
* a meta-analysis of 41 RCT studies (Katan et al. 2003)
* RCT studies with various food matrices; single and multiple daily intakes (Beer et al., 2001; Clifton et al., 2004; Doornbos et al., 2006; Mensink et al. and others)
* a confidential unpublished meta-analysis of 84 RCT (parallel and cross-over)
115
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
116
Describe the combination of beta-sitosterol and beta-sitosterol glucoside and normal
function of the immune system claim.
* The Panel considers that the claimed effect does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
* The Panel concludes that a cause-and-effect relationship cannot be established between consuming a combination of beta-sitosterol and beta-sitosterol glucoside and a beneficial physiological effect.
## Footnote
This claim was rejected.
117
Describe a permitted children's health claim.
Vitamin D contributes to the normal
function of the immune system. The
target population is infants and young
children up to three years of age
118
Describe restrictions on health claims. [3]
* Claims must be scientifically justified and in the context of a healthy diet
* No claim allowed for prevention, treatment, mitigation, or curing of disease
* Foods with high content of some nutrients (fat, sugar, salt) are not allowed to bear claims
* One of the nutrients is permitted to exceed the limit but must carry a label warning (e.g., “High in Salt”)
* Slimming/weight control products must not refer to the rate or amount of weight loss
## Footnote
Slimming/weight control claims are not allowed in US/Canada.
119
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
120
Describe the traceability and labelling of GMO foods. [3]
## Footnote
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)
121
The wording 'organic' on labels is only allowed [...].
on foods that are produced under high standards regarding the protection of the environment and animal
## Footnote
Strict prohibition of the use of GMOs, synthetic pestides, fertilizers, and antibiotics
122
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)
123
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.
124
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
125
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)**
## Footnote
**There is no mandatory requirement for serving sizes!**
126
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
127
What are the expanded categories of novel foods? [6]
* Food supplements
* Insects
* New sources of vitamins and minerals
* Nanomaterials (materials that are <100 nm in size)
* Food obtained from new technologies (UV)
* Products outside EU (noni juice, chia seeds etc.)
128
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:
129
Regarding novel foods, what must be demonstrated? [3]
* Is safe and does not present a danger to the consumer
* Does not mislead the consumer
* Does not differ from the products which they are intended to replace to such an extent that their normal consumption
would be nutritionally disadvantageous for the consumer
130
Describe new novel foods authorization.
131
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)
132
What are the four approved insect species?
* Migratory locust
* Yellow mealworm
* House cricket
* Lesser mealworm
133
How should health claims be scientifically substantiated? [3]
* Health claims should be **scientifically substantiated**:
* by the totality of the available scientific data
* by weighing the evidence
* should only be authorized for use after a scientific assessment... by the European Food Safety Authority
