Canada, USA & EU Regulations

We have included relevant Canadian, American & European Union regulatory information along with the respective dynamic references that can be verified. If you have further questions regarding the allergen lists, food labeling laws, declarations & definitions listed, please feel free to get into contact with us & we will be happy to answer you in more detail.

Food Allergens

Canada

The ten priority food allergens include:

• Peanuts

• Eggs

• Milk

• Tree Nuts

• Wheat (including spelt and kamut)

• Soy

• Sesame Seeds

• Seafood (Fish, Crustaceans and Shellfish)

• Sulphites

• Mustard

http://www.hc-sc.gc.ca/fn-an/securit/allerg/fa-aa/index-eng.php

 

The new revised regulations to enhance food allergen labelling will also cover gluten sources, which must be avoided by those with celiac disease, and added sulphites, which must be avoided by those with a sensitivity to sulphites. The revised regulations will require that manufacturers clearly identify food allergens, gluten sources, and sulphites either in the list of ingredients or at the end of the list of ingredients with the following statement "Contains: . . . ''. The regulations will also require that manufacturers list components of ingredients if they contain food allergens, gluten sources, or sulphites. For example, if a prepackaged food contains the ingredient "spices", that food will be required to list any allergens, gluten sources, or sulphites present in the spices.

http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_23bk-eng.php

 

Gluten sources include: barley, oats, rye, triticale, wheat or any modified gluten protein fraction.

Food allergen or gluten sources will be written in commonly used words such as (“milk” or “wheat”)

http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2011/2011_23bk-eng.php

 

Sulphites will still have to be declared at any level of use when directly added to a food as a food additive or when indirectly added to a food as components of an ingredient that is not exempted from component declaration. In addition, the new regulations will require that sulphites added as components of an ingredient exempted from component declaration will have to be declared when the total amount of sulphites contained within the food is 10 parts per million or more in the finished product.

http://www.hc-sc.gc.ca/fn-an/label-etiquet/allergen/project_1220_qa_qr-eng.php

 

USA

The 8 major food allergens include:

• milk

• egg

• fish

• crustacean, shellfish

• tree nuts

• wheat

• peanuts

• soybeans

http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm

 

21 CFR 101.100 Food; exemptions from labeling

(a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients).

(4) For the purposes of paragraph (a)(3) of this section, any sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, potasssium bisulfite, sodium metabisulfite, and potassium metabisulfite) that has been added to any food or to any ingredient in any food and that has no technical effect in that food will be considered to be present in an insignificant amount only if no detectable amount of the agent is present in the finished food. A detectable amount of sulfiting agent is 10 parts per million or more of the sulfite in the finished food. Compliance with this paragraph will be determined using sections 20.123–20.125, “Total Sulfurous Acid,” in “Official Methods of Analysis of the Association of Official Analytical Chemists,” 14th Ed. (1984), which is incorporated by reference and the refinements of the “Total Sulfurous Acid” procedure in the “Monier-Williams Procedure (with Modifications) for Sulfites in Foods,” which is appendix A to part 101. A copy of sections 20.123–20–125 of the Official Methods of Analysis of the Association of Official Analytical Chemists” is available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr.... http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.100

 

EU

The 14 food allergens include:

• 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

• Peanuts and products thereof

• Soybeans and products thereof

• Milk and products thereof (including lactose)

• Nuts i.e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof

• Celery and products thereof

• Mustard and products thereof

• Sesame seeds and products thereof

• Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or 10 mg/litre expressed as SO2

• Lupin and products thereof

• Molluscs and products thereof

http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/comm_legisl_en.htm

http://www.food.gov.uk/safereating/allergyintol/label/

 

Flavours

Canada

Defined by Canada Food and Drugs Regulation, Division 10 "Flavouring Preparations." B.10.005. [S]. (naming the flavour) Flavour

(a) shall be a preparation, other than a flavouring preparation described in section B.10.003, of sapid or odorous principles, or both, derived from the aromatic plant after which the flavour is named;

(b) may contain a sweetening agent, food colour, Class II preservative, thaumatin, Class IV preservative or emulsifying agent; and

(c) may have added to it the following liquids only:

(i) water,

(ii) any of, or any combination of, the following: benzyl alcohol; 1, 3-butylene glycol, ethyl acetate, ethyl alcohol, glycerol, glyceryl diacetate, glyceryl triacetate, glyceryl tributyrate, isopropyl alcohol, monoglycerides and diglycerides; 1, 2-propylene glycol or triethylcitrate,

(iii) edible vegetable oil, and

(iv) brominated vegetable oil, sucrose acetate isobutyrate or mixtures thereof, when such flavour is used in beverages containing citrus or spruce oils.

http://laws.justice.gc.ca/eng/regulations/C.R.C.,_c._870/page-112.html

 

Canada's Food and Drugs Act and Regulations are administered and enforced by the Canadian Food Inspection Agency (CFIA). An ingredient must be listed in the ingredients list by its common name, as required by B.01.010(2) of the Food and Drug Regulations.

http://www.inspection.gc.ca/english/fssa/labeti/decisions/ingrede.shtml

 

USA

Defined in the United States Code of Federal Regulations, Title 21 Section 101.22

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.22

 

Ingredient list must list the common or usual name for ingredients unless there is a regulation that provides for a different term.  Spices and flavors may be declared in ingredient lists by using either specific common or usual names or by using the declarations “spices,” “flavor” or “natural flavor,” or “artificial flavor.”

http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodlabelingnutrition/foodlabelingguide/ucm064880.htm

 

EU

As per Article 3 (2a) ‘flavourings’ shall mean products:

(i) not intended to be consumed as such, which are added to food in order to impart or modify odour and/or taste;

(ii) made or consisting of the following categories: flavouring substances, flavouring preparations, thermal process

flavourings, smoke flavourings, flavour precursors or other flavourings or mixtures thereof; “Flavouring preparation” is a product obtained from: (i) food by appropriate physical, enzymatic or microbiological processes either in the raw state of the material or after processing for human consumption by one or more of the traditional food preparation processes listed in Annex II; and/or

(ii) material of vegetable, animal or microbiological origin, other than food, by appropriate physical, enzymatic or microbiological processes, the material being taken as such or prepared by one or more of the traditional food preparation processes listed in Annex II

http://ec.europa.eu/food/fs/sfp/flav_index_en.html

 

 

Natural Flavour

Canada

Foods or ingredients of foods submitted to processes that have significantly altered their original physical, chemical or biological state should not be described as "natural". This includes such changes as the removal of caffeine.

• Product should not contain an added vitamin, mineral nutrient, artificial flavouring agent or food additive.

• Product does not have any constituent or fraction thereof removed or significantly changed, except the removal of water.

http://www.inspection.gc.ca/english/fssa/labeti/guide/ch4ae.shtml

 

USA

Title 21 Sec. 101.22 (3) The term natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.22

 

EU

From Article 16 of Regulation No 1334/2008:

Specific requirements for use of the term ‘natural’

1. If the term ‘natural’ is used to describe a flavouring in the sales description referred to in Article 15(1)(a) the provisions of paragraphs 2 to 6 of this Article shall apply.

2. The term ‘natural’ for the description of a flavouring may only be used if the flavouring component comprises only flavouring preparations and/or natural flavouring substances.

3. The term ‘natural flavouring substance(s)’ may only be used for flavourings in which the flavouring component contains exclusively natural flavouring substances.

4. The term ‘natural’ may only be used in combination with a reference to a food, food category or a vegetable or animal flavouring source if the flavouring component has been obtained exclusively or by at least 95 % by w/w from the source material referred to.

 

The description shall read ‘natural “food(s) or food category or source(s)” flavouring’.

5. The term ‘natural “food(s) or food category or source(s)” flavouring with other natural flavourings’ may only be used if the flavouring component is partially derived from the source material referred to, the flavour of which can easily be recognised.

6. The term ‘natural flavouring’ may only be used if the flavouring component is derived from different source materials and where a reference to the source materials would not reflect their flavour or taste.

 

 

Artificial Flavour

Canada

B.10.006. [S]. Artificial (naming the flavour) Flavour or Imitation (naming the flavour) Flavour shall be a flavour except that the flavouring principles may be derived in whole or in part from sources other than the aromatic plant after which it is named, and if such flavour is defined in these Regulations, the flavouring strength of the artificial or imitation flavour shall be not less than that of the flavour.

http://laws.justice.gc.ca/eng/regulations/C.R.C.,_c._870/page-112.html

 

USA

Title 21 Sec. 101.22 (a)(1) The term artificial flavor or artificial flavoring means any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof. Artificial flavor includes the substances listed in 172.515(b) and 182.60 of this chapter except where these are derived from natural sources.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=101.22

 

Cosmetics & Fragrance

International Fragrance Association (IFRA)

Official representative body of the fragrance industry worldwide; Its main purpose is to ensure the safety of fragrance

materials. 

The IFRA recommendations are grouped into three categories:

1. Prohibited standards: The material should not be used as a fragrance ingredient.

2. Restricted standards: The use of the material should be limited quantitatively.

3. Standard specification: The material should only be used if it meets certain purity criteria or if it used in conjunction with other materials.

http://www.ifraorg.org/

 

 

International Nomenclature of Cosmetic Ingredient

Unlike food ingredient lists, cosmetic products use INCI names. International Nomenclature of Cosmetic Ingredient (INCI) is a uniform system of naming cosmetic ingredients. INCI names are specific and based on chemical structure or composition. For example, if a cosmetic product contains Lavender Oil, the ingredient list should read: Lavandula Angustifolia (Lavender) Oil.

http://www.hc-sc.gc.ca/cps-spc/legislation/pol/compliance-inci-conformite-eng.php

http://edocket.access.gpo.gov/cfr_2007/aprqtr/21cfr701.3.htm

http://ec.europa.eu/consumers/sectors/cosmetics/cosing/index_en.htm

 

 

European Union Cosmetics Directive (76/768/EEC)

In the EU, as per Directive 76/768/EEC and its amendments, 26 fragrance substances must be labelled if they are present in products formulations at cncentrations greater than 0.01% for rinse-off and 0.001% for leave-on. The 26 fragrance materials are: Amyl cinnamal, Amylcinnamyl alcohol, Benzyl alcohol, Benzyl salicylate, Cinnamyl alcohol, Cinnamal, Citral, Coumarin, Eugenol, Geraniol, Hydroxycitronellal, Hydroxymethylpentyl-cyclohexenecarboxaldehyde, Isoeugenol, Anisyl alcohol, Benzyl benzoate, Benzyl cinnamate, Citronellol, Farnesol, Hexyl cinnamaldehyde, Lilial, d-Limonene, Linalool, Methyl heptine carbonate, 3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, Oak moss (Evernia Prunastri), Tree moss (Evernia Furfuracea).

http://ec.europa.eu/consumers/sectors/cosmetics/documents/directive/