The relationships betweenCodex Standards

andEuropean, national

Food safety and labelling Regulations

Dario Dongo © 2013Food law expertBruxelles – Milan – Romedario.dongo@me.com, (+39) 335 7313 726

Premise

• The Codex Alimentarius Commission (FAO & WHO, 1963) was built with the aim of protecting consumers’ health, by means of science-based common grounds.

• ‘The guidelines on food standards and other recommendations of Codex Alimentarius should be based on the principle of a strict scientific analysis and evidence, with a thorough review of all relevant information...’ *

• Yet ‘Codex Alimentarius, at the time of the drafting and adoption of food standards, will also consider, when appropriate, other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade.’*

2(*) FAO, 2002

Codex & WTO, SPS Agreement

• Under the SPS agreement, WTO, Codex provides worlwide criteria for risk assessment (RA)

Since the Uruguay Round (1994), Codex Alimentarius is recognised as the only authoritative body to solve divergencies in RA,* by setting Codex Guidelines

• In absence of specific Codex guidelines – or in case of national authorities wishing to improve the health protection level – Member States must rely on the risk assessment procedures

The appropriate level of public health to be pursued by MS, however, should not be discriminatory, but proportionate to the need of free trade, and applied in a responsible manner**

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(*) SPS - Sanitary and Phyto-Sanitary measures agreement, Art. 3.1(**) SPS, Art. 5.1

SPS, exceptions

• WTO members can adopt temporary SPS measures where the relevant scientific evidence is insufficient*Although this step has been regarded as a reflection of the precautionary principle, the SPS Agreement does not refer explicitly to it. Rather, to the search for an objective risk assessment in due time

• Members shall accept the sanitary or phytosanitary measures of other Members as equivalent, even if these measures differ from their own or from those used by other Members trading in the same product, if the exporting Member objectively demonstrates to the importing Member that its measures achieve the importing Member's appropriate level of sanitary or phytosanitary protection**

4(*) SPS, Art. 5.7(**) SPS, Art. 4

Codex Alimentarius & EU

• The EC has EXCLUSIVE COMPETENCE for matters on which the rules have already been harmonised – fully, or to a large extent - at EU levelIn such cases, the Commission speaks and votes in the name of the EU, although Member States have the right to speak in favour of the Community position and to react to contributions from other countries

• COMPETENCE is SHARED where rules have been only partially harmonizedthe vote is exercised either by the Member States or the Community (i.e. political agriculture, environmental policy, harmonization of human, animal & veg health)

• MEMBER STATES have EXCLUSIVE COMPETENCE for all organisational matters (e.g. legal or budgetary questions) and for procedural matters (e.g. election of chairpersons, adoption of agendas, approval of minutes)

5Council Decision 2003/822

Codex – EU, common groundsFood, notion

‘Food’ means any substance, whether processed, semi-processed or raw, which is intended for human consumption, and includes drinks, chewing gum and any substance which has been used in the manufacture, preparation or treatment of ‘food’ but does not include cosmetics or tobacco or substances used only as drugs.

`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. ‘Food’ includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment.

Codex - General Standard for labelling of pre-packed foods (1985)

EU General Food Law (Reg. EC 178/2002 Article 2)

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Codex – EU, common groundsConsumer, definition

‘Consumer’ means persons and families purchasing and receiving food in order to meet their personal needs

‘final consumer’ means the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity.

Codex - General Standard for labelling of pre-packed foods (1985)

General Food Law (Reg. EC 178/02, Article 3)

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Codex – EU, common groundsLabelling, concept

‘Labelling’ includes any written, printed or graphic matter that is present on the label, accompanies the food, or is displayed near the food, including that for the purpose of promoting its sale or disposal

- ‘labelling’ means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food

+- ‘food information’ means information concerning a food and made available to the final consumer by means of a label, other accompanying material, or any other means including modern technology tools or verbal communication (…)

Codex - General Standard for labelling of pre-packed foods (1985)

Food Information to Consumer (Reg. EU 1169/2011, Article 2)

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Codex – EU, common groundsLabelling, the golden rule

3.1 Prepackaged food shall not be described or presented on any label or in any labelling in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character in any respect.

Without prejudice to more specific provisions of food law, the labelling, advertising and presentation of food (…), including their shape, appearance or packaging, the packaging materials used, the manner in which they are arranged and the setting in which they are displayed, and the information which is made available about them through whatever medium, shall not mislead consumers.

Codex - General Standard for labelling of pre-packed foods (1985)

General Food Law (Reg. EC 178/02, Article 16)

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Codex – EU, common groundsLabelling, legibility

8.1.2 Statements required to appear on the label by virtue of this standard or any other Codex standards shall be clear, prominent, indelible and readily legible by the consumer under normal conditions of purchase and use.

8.1.3 Where the container is covered by a wrapper, the wrapper shall carry the necessary information or the label on the container shall be readily legible through the outer wrapper or not obscured by it.

+8.1.4 The name and net contents of the food shall appear in a prominent position and in the same field of vision

‘legibility’ means the physical appearance of information, by means of which the information is visually accessible to the general population and which is determined by various elements, inter alia, font size, letter spacing, spacing between lines, stroke width, type colour, typeface, width- height ratio of the letters, the surface of the material and significant contrast between the print and the background

+Minimum font size

+Name and quantity in the same field of vision

Codex - General Standard for labelling of pre-packed foods (1985)

Food Information to Consumer (Reg. EU 1169/2011, Article 2)

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Codex – EU, common groundsNutrition labelling

2.1 Nutrition labelling is a description intended to inform the consumer of nutritional properties of a food.

2.2 Nutrition labelling consists of two components: (a) nutrient declaration; (b) supplementary nutrition information.

2.3 Nutrient declaration means a standardized statement or listing of the nutrient content of a food.

‘nutrition declaration’ or ‘nutrition labelling’ means information stating the:

(a)energy value; or

(b) energy value and one or more of the following nutrients only: fat (saturates, mono-unsaturated, polyunsaturated), carbohydrate (sugars, polyols, starch), salt, fibre, protein, any of the vitamins or minerals listed in point 1 of Part A of Annex XIII (…)

Codex - General Guide onNutrition labelling (1985)

Food Information to Consumer (Reg. EU 1169/2011, Annex I)

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Codex – EU, common groundsNutrition labelling

2.1 Nutrition labelling is a description intended to inform the consumer of nutritional properties of a food.

2.2 Nutrition labelling consists of two components: (a) nutrient declaration; (b) supplementary nutrition information.

2.3 Nutrient declaration means a standardized statement or listing of the nutrient content of a food.

‘nutrition declaration’ or ‘nutrition labelling’ means information stating the:

(a)energy value; or

(b) energy value and one or more of the following nutrients only: fat (saturates, mono-unsaturated, polyunsaturated), carbohydrate (sugars, polyols, starch), salt, fibre, protein, any of the vitamins or minerals listed in point 1 of Part A of Annex XIII (…)

Codex - General Guide on Nutrition labelling (1985)

Food Information to Consumer (Reg. EU 1169/2011, Annex I)

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Codex – EU, common groundsNutrition labelling, application

3.1.1. Nutrient declaration should be mandatory for all prepackaged foods for which nutrition or health claims (…) are made.

3.1.2 Nutrient declaration should be mandatory for all other prepackaged foods except where national circumstances would not support such declarations. Certain foods may be exempted for example, on the basis of nutritional or dietary insignificance or small packaging.

Compulsory nutrition declaration for all food items (Article 9, “l”).

Exceptions: Chewing gums, amid others, are EXEMPTED (Annex V)

Codex - General Guide on Nutrition labelling (1985)

Food Information to Consumer (Reg. EU 1169/2011, Annex I)

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Codex – EU, common groundsNutrition labelling, presentation & legibility

4.2.2 Format – Nutrient content should be declared in a numerical, tabular format. Where there is insufficient space for a tabular format, nutrient declaration may be presented in a linear format. 4.2.3 Nutrients should be declared in a specific order developed by competent authorities and should be consistent across food products. 4.2.4 Font – The font type, style and a minimum font size as well as the use of upper and lower case letters should be considered by competent authorities to ensure legibility of nutrition labelling. 4.2.5 Contrast – A significant contrast should be maintained between the text and background so as to be that the nutrition information is clearly legible.

1. The particulars referred to in Article 30(1) and (2) shall be in the same field of vision. They shall be presented together in a clear format and, where appropriate, in the order of presentation provided for in Annex XV.

2. The particulars referred to in Article 30(1) and (2) shall be presented, if space permits, in tabular format with the numbers aligned. Where space does not permit, the declaration shall appear in linear format.

3. The particulars referred to in Article 30(3) shall be presented: (a) in the principal field of vision; and (b) using a font size in accordance with Article 13(2).

Codex - General Guide on Nutrition labelling (1985)

Food Information to Consumer (Reg. EU 1169/2011, Article 34)

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Codex – EU, common groundsNutrition labelling, thresholds

There’s no Codex provision about

“Contains negligible amounts of...”

5. In cases where the energy value or the amount of nutrient(s) in a product is negligible, the information on those elements may be replaced by a statement such as ‘Contains negligible amounts of …’ and shall be indicated in close proximity to the nutrition declaration when present.

Codex - General Guide on Nutrition labelling (1985)

Food Information to Consumer (Reg. EU 1169/2011, Art. 34)

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Codex – EU, common groundsNutrition claims (1)

Low Energy40kcal per 100g, or 20kcal per 100ml

Free Energy4 kcal per 100 ml (liquids)

Sugars Free 0.5g per 100 g/ml

Low energySame conditions as Codex

+-> Table-top sweeteners, 4kcal/portion, with equivalent sweetening properties to 6g of sugar

Free energy (‘0 calories’)Same as Codex

+-> Table-top sweeteners, 0,4kcal/portion, with equivalent sweetening properties to 6g of sugar

Sugars free, same as

Codex Guidelines for the use ofNutrition & Health Claims

NHC Regulation (Reg. EC 1924/06, Annex)

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Codex – EU, common groundsNutrition claims (2)

NON-ADDITION OF SUGARS Claims regarding the non-addition of sugars to a food may be made provided the following conditions are met. (a) No sugars of any type have been added to the food (Examples: sucrose, glucose, honey, molasses, corn syrup, etc.); (b) The food contains no ingredients that contain sugars as an ingredient (Examples: jams, jellies, sweetened chocolate, sweetened fruit pieces, etc.); (c) The food contains no ingredients containing sugars that substitute for added sugars (Examples: non-reconstituted concentrated fruit juice, dried fruit paste, etc.); and (d) The sugars content of the food itself has not been increased above the amount contributed by the ingredients by some other means (Example: the use of enzymes to hydrolyse starches to release sugars)

WITH NO ADDED SUGARSA claim may only be made where the product does not contain any added mono- or disaccharides or any other food used for its sweetening properties. If sugars are naturally present in the food, the following indication should also appear on the label: ‘CONTAINS NATURALLY OCCURRING SUGARS’.

Diverging interpretations amid MS authorities -> enforcement troubles

Codex Guidelines for the use ofNutrition & Health Claims

NHC Regulation (Reg. EC 1924/06, Annex)

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EU, health claims, sugar replacers (1)

• INGREDIENTS: sugar replacers, i.e. intense sweeteners. Xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, sucralose and polydextrose; D-tagatose and isomaltulose

• CLAIM: “CONSUMPTION OF FOODS/ DRINKS CONTAINING <NAME OF SUGAR REPLACER> INSTEAD OF SUGAR (*) INDUCES A LOWER BLOOD GLUCOSE RISE AFTER THEIR CONSUMPTION COMPARED TO SUGAR- CONTAINING FOODS/DRINKS”

• CONDITIONS OF USE: In order to bear the claim, sugars should be replaced in foods or drinks by sugar replacers, i.e. intense sweeteners, xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, sucralose or polydextrose, or a combination of them, so that foods or drinks contain reduced amounts of sugars by at least the amount referred to in the claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/2006. In the case of D-tagatose and isomaltulose, they should replace equivalent amounts of other sugars in the same proportion as that referred to in the claim REDUCED [NAME OF NUTRIENT] as listed in the Annex to Regulation (EC) No 1924/2006

18Reg.(EU) 432/2012

EU, health claims, sugar replacers (2)

• CLAIM: “CONSUMPTION OF FOODS/ DRINKS CONTAINING <NAME OF SUGAR REPLACER> INSTEAD OF SUGAR (**) CONTRIBUTES TO THE MAINTENANCE OF TOOTH MINERALISATION”

• CONDITIONS: in order to bear the claim, sugars should be replaced in foods or drinks (which reduce plaque pH below 5.7) by sugar replacers, i.e. intense sweeteners, xylitol, sorbitol, mannitol, maltitol, lactitol, isomalt, erythritol, D-tagatose, isomaltulose, sucralose or polydextrose, or a combination of them, in amounts such that consumption of such foods or drinks does not lower plaque pH below 5.7 during and up to 30 minutes after consumption

19Reg.(EU) 432/2012

EU – MS - Codex Alimentarius

• Language requirements -> 24 is TOO much!*

• National provisions* -> discrimination, TBT vs. free circulation of goods

• Nutrition declaration –> Sodium* vs. Salt (as Sodium equivalent)

• Comparative claims –> 30** vs. 25%. Terms of reference

• Health claims -> clinical data based on double blind tests on healthy individuals*** vs. generally accepted scientific evidence

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Labelling, space for improvement

(*) Reg. EU 1169/11(**) Reg. EC 1924/06(***) Reg. EC 353/08

EU regulatory frameworkis uncertainty raising?

• ANSES (F) takes the lead on RA on energy drinks, bisphenol A, aspartame, GMOs ... BEFORE AND BESIDE EFSA!

• BfR (D) also• UK runs ahead (i.e. traffic light hybrid system and Reg. UE 1169/11)• Both issues - food safety and labelling – are under the focus of many

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DRV’s for sugars

• EFSA scientific opinion on Dietary Reference Values for carbohydrates and dietary fibre*

• Frequency of consumption of sugars seems more relevant than overall quantity -> clear understanding that candies and chewing gum have a great potential for a negative impact

• However, not intervening on sugars daily DRVs left consumers and NGOs with suspects of industry-driven risk assessment -> (see EFSA’s page on scientific controversies http://www.efsa.europa.eu/en/faqs/faqdrv.htm)

22(*) EFSA Journal 2010; 8(3):1462 [77 pp.]

The aspartame dossier

• EFSA has repeatedly confirmed its first TDI (40 mg/kg/body weight, 2006)

• Latest Call for Data (2011) led EFSA to retrive 112 unpublished scientific works and data used to approve it

• Rumors and conditioning factors. No other EU Member State has ever banned nor restricted aspartame use from 1971 to date

• Final opinion (re-evaluation) is expected from EFSA by November 2013

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Stevia rebaudiana

• Approval from the EC in 2011

• Consumers may still lack the adequate knowledge to give a positive value and a prominent role to Stevia in the ‘no calories sweeteners’ list

• Costs. Aspartame 30 US$/kg, Stevia drops >100 $/kg

Are there new chances for its extensive use?

24Commission Reg. (EU) No 1131/2011

Bisphenol A

• Plastic boxes of chewing gum may be considered as a hypotetical source of BPA

• More than the overall contribution to Tolerable Weekly Intake/Tolerable Daily Intake, which could be a minor/ of no concern, attention should be paid to the consumers’ response

• Steady adoption of ‘BPA-free’ regulatory environments at the

MS level could foster industry to adopt new BPA-free technology even in countries where it is still allowed

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‘Post-Normal science’

• Under conditions of scientific uncertainty and in the presence of conflicting opinions - but with a social urgency of the introduction of technology (market demand) - science cannot proceed for successive ‘jumps’ from one paradigm to another [Kuhn , 1962], with phases of standardization in the middle (‘normal science’)

• This is the ‘post-normal science’ [Funtowicz, 1992, 1993], a ‘post-modernist’ interpretation of the scientific method

• Science would no longer explain reality. RISK ASSESSMENT is plural, controversial, relative, path dependent, society & stakeholders sensitive*

• More room is left to the Science-Policy making-Regulatory affairs-Media INTERPLAY

26See FAO (2002), ‘other legitimate factor’, in addition to science

CONCLUSIONS

• EFSA is still ‘under attack’. From other scientific bodies at national and international level (which paradoxically form the network EFSA is built on!) and the (sometimes interested) stakeolders

• The consequent lack of scientific clarity and/or its recognition may

- DELAY INNOVATION and public acceptance of new technologies and substances

- PROVIDE OPPORTUNITIES for those who wish to set any kind of rules- DECREASE HARMONIZATION OF FOOD SAFETY STANDARDS, by leaving

ground to SAFEGUARDS CLAUSES AT NATIONAL LEVEL. This holds particularly true for those Member States having powerful food safety assessment bodies (F, D, UK), and generally speaking, more political strenght

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