WORKSHOP ON REGULATION (EC) N 1924/2006 · 1 COM(2015) 215 final. Communication from the Commission...

ADVISORY GROUP ON THE FOOD CHAIN, ANIMAL AND PLANT HEALTH

WORKSHOP ON REGULATION (EC) NO 1924/2006

(NUTRIENT PROFILES AND HEALTH CLAIMS ON PLANTS AND THEIR PREPARATIONS,

INCLUDING THE GENERAL REGULATORY FRAMEWORK FOR THEIR USE IN FOODS)

Centre Borschette

14:30 – 18:00

21 June 2016

FCEC working document

This document is addressed to participants to the above workshop of the

Advisory Group on the food chain, animal health and plant health. The meeting

is taking place in the context of the independent study supporting the evaluation

of a) Regulation (EC) No 1924/2006 on nutrition and health claims made on

food ('the Regulation') with regard to nutrient profiles and health claims made

on plants and their preparations and of b) the general regulatory framework for

their use in foods. The study is being carried out for the European Commission

by the Food Chain Evaluation Consortium (FCEC), led by Agra CEAS

Consulting; it is being conducted in collaboration with Areté.

The document has been prepared by the FCEC and does not necessarily

present the views of the Commission.

Study on Regulation (EC) No 1924/2006: FCEC working document

Workshop with stakeholders, Brussels, 21 June

-------------------------------------------------------------------------------------------

ii | Food Chain Evaluation Consortium (FCEC)

Contents

Background to the workshop ................................................................................................... iii

Objectives of the workshop ...................................................................................................... iv

1. Task 1: Nutrient profiles ..................................................................................................... 1

Background ............................................................................................................................ 1

Questions................................................................................................................................ 2

2. Task 2: health claims made on plants and their preparations and the general regulatory

framework for their use in foods ................................................................................................ 5

Background ............................................................................................................................ 5

Questions................................................................................................................................ 7

Annex 1 .................................................................................................................................... 10

Acronyms and abbreviations.................................................................................................... 12



-------------------------------------------------------------------------------------------

iii | Food Chain Evaluation Consortium (FCEC)

Background to the workshop

Following the Better Regulation Communication of 19 May 20151

the Commission

announced that, as part of its REFIT programme, it will carry out an evaluation of

Regulation (EC) No 1924/2006 with regard to nutrient profiles and health claims made

on plants and their preparations. This evaluation will also consider the more general

regulatory framework for the use of such substances in foods since it is closely related to

the use of health claims.

A study contributing to the above evaluation is currently undertaken for the Directorate

General for Health and Consumers (DG SANTE) of the European Commission. The study is

led by Agra CEAS Consulting of the Food Chain Evaluation Consortium (FCEC), and is

being carried out in cooperation with Areté.

The purpose of the study is to provide an evidence base to feed into the Commission’s

evaluation by assessing whether (i) nutrient profiles; and, (ii) health claims on plants and

their preparations and the more general regulatory framework for their use can be considered

to be “fit for purpose”. In particular, it aims to analyse the current situation, effectiveness,

efficiency, relevance coherence, and EU added value of the legislative framework introduced

by Regulation (EC) No 1924/2006, placing it also in the context of other relevant legislative

and non-legislative provisions. As a result of the assessment of these elements, the study will

conclude on the extent to which the Regulation has achieved its overall objectives, with

regard to its provisions on nutrient profiles and health claims on plants and their preparations,

whilst imposing the minimum burden.

The study comprises two tasks which are discussed below.

Task 1: Assessment of the operation of Article (4)1 Regulation (EC) No 1924/2006

with regard to nutrient profiles;

Task 2: Assessment of the operation of Regulation (EC) No 1924/2006 (Article 13)

with regard to health claims on plants and their preparations and the more general

regulatory framework for their use in food.

It is noted that both of these provisions have not to date been applied as foreseen in

Regulation (EC) No 1924/2006; their evaluation presents therefore some challenges in that it

is an assessment of non-implementation.

The study involves collection of data and information through desk research, an on-line

survey of organisations representing operators along the feed and food supply chain (‘from

farm to fork’), an on-line survey of MS Competent Authorities (CAs), consultation of SMEs

through the EEN SME Panel, public consultation, and case studies in selected Member

States. The latter will involve interviews of CAs and stakeholders, at both EU and MS level.

1 COM(2015) 215 final. Communication from the Commission to the European Parliament, the Council, the

European Economic and Social Committee and the Committee of the Regions. Better regulation for better

results - An EU agenda.

http://ec.europa.eu/smart-regulation/better_regulation/documents/com_2015_215_en.pdf



-------------------------------------------------------------------------------------------

iv | Food Chain Evaluation Consortium (FCEC)

Objectives of the workshop

The study was launched in late May and the consultation process has just started. The

purpose of this workshop of the Advisory Group is to present the study and to invite

stakeholders to prepare and provide their views and inputs (data) concerning the various

issues under review. In particular, the workshop will give the opportunity to the FCEC to

present the objectives and methodology of the study, gather initial feedback on key issues and

problem areas with the current situation, provide clarifications and encourage concrete inputs

and contribution to the on-line survey consultation and case studies.

This Working Document aims to facilitate this initial discussion, by providing an overview of

the issues considered by the study and the qualitative and quantitative data needed to assess

whether the relevant provisions of Regulation (EC) No 1924/2006 are “fit for purpose”.

Your contribution as stakeholders is highly encouraged during and after the workshop:

- During the meeting: you will have the opportunity to contribute your comments and

feedback to the questions outlined in this document;

- After the meeting: you are kindly invited to start preparing to gather the data and

quantitative/qualitative evidence that are relevant for consideration under this study.

The questions raised in this document point to the type of data that will be requested

from stakeholders for this study. To this end, you are invited to distribute this

working document further to your member organisations at national level.

Please consult both the present document and the ToR of the

study2 ahead of the workshop meeting.

THE FCEC TEAM THANKS YOU IN ADVANCE FOR YOUR

COOPERATION IN THIS STUDY

2 http://ec.europa.eu/food/safety/labelling_nutrition/claims/refit/index_en.htm

http://ec.europa.eu/food/safety/labelling_nutrition/claims/refit/index_en.htm



-------------------------------------------------------------------------------------------

1 | Food Chain Evaluation Consortium (FCEC)

1. Task 1: Nutrient profiles

Background

The objective of Regulation (EC) No 1924/2006 with regard to the development of

harmonised nutrient profiles across the EU for foods bearing nutrition and health claims

was to provide a high level of consumer protection whilst ensuring the effective functioning

of the internal market. The application of nutrient profiles as a criterion for determining

whether a product can bear claims aims to avoid a situation where nutrition or health claims

mask the overall nutritional status of a food product, which could mislead consumers when

trying to make healthy choices in the context of a balanced diet. Thus, in the context of the

Regulation, nutrient profiles consist in maximum levels of nutrients such as saturated fat, salt

and sugars above which nutrition claims are restricted and health claims are prohibited.

Article (4)1 of the Regulation envisaged the adoption of nutrient profiles, by 19 January

2009, in consultation with EFSA and affected stakeholders (consumers and food business

operators). EFSA adopted a scientific opinion on the setting of nutrient profiles in 20083,

following which the Commission drafted a proposal in 20094. However, the setting of

nutrient profiles was postponed due to the complexity of the subsequent discussions, where

certain sectors of the food industry pointed to alleged economic losses and lower

competitiveness expected from an implementation of the proposed system.

Given that the nutrient profiles provided for in the Regulation have not yet been adopted, the

purpose of the study is to examine the current situation - as it has evolved in the absence of

harmonised profiles - and to assess the extent to which harmonisation remains necessary to

ensure the overall objectives of the Regulation and specifically to avoid a situation where

nutrition or health claims mask the overall nutritional quality of a food.

In making this assessment, the study will consider the potential impacts of the setting of

nutrient profiles at EU level and whether there are alternative and less burdensome solutions

to achieve the Regulation’s objectives, including other existing harmonised legislation and

non-harmonised, national, initiatives (including consideration of alternative approaches

adopted in non-EU countries).

In the context of other relevant harmonised legislation, Regulation (EU) No 1169/2011 on

food information to consumers provides that:

Nutrition or health claims can only be made on food labelled with a factual indication

of its nutritional content (‘nutritional declaration’), to become mandatory for all foods

from December 2016. Although there is no legal link between certain levels of fat,

sugars and salt and the possibility to make health and nutrition claims, some degree of

consumer protection is provided through this factual information. The extent to which

this provides a sufficient level of consumer protection will have to be assessed.

In addition, simplified nutrition labelling schemes are increasingly being used on the

front of packs and, where this is the case, this provides further information to the

consumer. From a regulatory point of view, this form of indication is sometimes

3 https://www.efsa.europa.eu/en/efsajournal/pub/644

4 The Commission’s draft proposal was not adopted/published. The main elements of the proposal are outlined

in Annex 1. This proposal serves as the baseline for analysing impacts in the context of this study.

https://www.efsa.europa.eu/en/efsajournal/pub/644



-------------------------------------------------------------------------------------------


considered as an alternative means of expression of the ‘nutritional declaration’. These

systems sometimes use a logo to identify healthier nutritional options; this logo can be

considered a nutrition claim5. Although these are not harmonised, they should be in

line with EU nutrient profiles, if these are ultimately set.

The study needs to consider these alternative routes through which the objectives of the

Regulation might be achieved in the absence of setting harmonised nutrient profiles at EU

level. In doing this, we will need to consider the costs and benefits, as well as other

advantages and disadvantages of a non-harmonised solution, and the implications of a

voluntary versus a mandatory approach. It is noted that nutrient profiles have to be based on

generally acceptable scientific data relative to the relationship between diet and health; they

should also, following the Regulation, take into account other considerations such as the need

to allow for product innovation, the variability of dietary habits and culinary traditions.

------------------

Questions

Note: the text in bold below indicates the main question and the sub-questions point to more detailed topics covered under the main question. Sub-questions in black indicate the main focus of the discussion during the workshop, while sub-questions in grey indicate the topics for which further data/feedback are requested from stakeholders.

We would like to discuss, and receive feedback and any available evidence from stakeholders

on the following aspects:

1. How has the regulatory framework relating to nutrient profiles evolved at national

(Member State) level in the absence of EU nutrient profiles?

a) To what extent have national regulatory and non-regulatory initiatives (i.e. setting of

nutrient profiles; simplified nutrition labelling schemes; private schemes and other

initiatives) been developed in the various Member States? Please provide concrete

examples for our consideration, especially where Member States follow markedly

different approaches or there are no national initiatives

b) To what extent are any of the above science-based? Please identify and focus on the

science-based initiatives.

c) To what extent are any of the above used for the same purpose as the intended

nutrient profiles under Regulation (EC) No 1924/2006/EC, i.e. for determining

whether a product can bear claims? Please identify and focus on the initiatives

associated with conditions for approving/rejecting claims.

d) To what extent are the current national approaches fragmented and diverse? Why

have initiatives emerged in some Member States and not in others? What are the key

drivers?

e) To what extent have these national approaches:

o Provided accurate and reliable information for consumers?

o Had an impact on the free circulation of goods within the internal market?

5 One example is the Swedish keyhole logo, which packaged foods are eligible to carry provided they fulfil

certain conditions based on the Nordic Nutrition Recommendations (founded on scientific research), as

specified by the authorities in Sweden, Denmark, Norway and Iceland.



-------------------------------------------------------------------------------------------


o Provided legal certainty / fair competition for operators?

o Ensured the promotion and protection of food innovation?

2. Has the evolution of the EU market been affected by the non-setting of nutrient

profiles at EU level? How and why? Please consider whether, how and why the market

of food products bearing claims, in the various sectors/categories of foods, has been

affected by the non-setting of nutrient profiles at EU level.

a) To what extent has the non-setting of harmonised EU nutrient profiles interfered

with the evolution of the market of products bearing claims? Has it acted as a

hindrance or has it encouraged market trends?

b) To what extent are any identified differences in market trends between Member

States affected by specific regulatory and non-regulatory initiatives taken in the

various Member States (i.e. setting of nutrient profiles; simplified nutrition labelling

schemes; private schemes and other initiatives)?

c) To what extent is the internal market affected by disparities in approaches and

initiatives taken by Member States (see Q1.d)?

3. In previous discussions on the development of EU nutrient profiles, certain sectors of the

food industry pointed to expected economic losses and lower competitiveness. What

would be the potential costs6 associated with the setting of nutrient profiles at EU

level? Which products would be negatively affected? Please consider the costs of a

harmonised approach, as outlined in Annex 1, in comparison to the current approach.

a) Which product categories would potentially be negatively affected by the setting of

nutrient profiles at EU level? How would they be affected and why? Please identify

which product categories would be negatively affected, i.e. in terms of potentially

bearing additional costs in comparison to the current approach.

b) What would be the main types of costs for the affected product categories? Please

identify types of costs, e.g. in terms of cost increases, market loss etc.

c) To what extent can costs be quantified? Please identify costs that can be quantified,

either generically (i.e. for the product category as a whole) or on a specific product

basis. Please prepare to estimate and justify these costs for later phases of the study.

d) Are there any costs and/or risks that could be expressed in monetary terms but

cannot be quantified? Are there any other (non-monetary) disadvantages? Can their

relative importance be measured and how? Please identify potential costs and other

non-monetary disadvantages that cannot be quantified, and suggest alternative

approaches for assessing the relative importance of these costs. These would

describe the potential costs and disadvantages of the setting of nutrient profiles at

EU level in terms of their ability to ensure:

o Accurate and reliable information for consumers?

o Free circulation of goods within the internal market?

o Legal certainty / fair competition for operators?

o Promotion and protection of food innovation?

4. Would there be any potential benefits associated with the setting of nutrient profiles

at EU level? Which products would benefit? Please consider the benefits of a

harmonised approach, as outlined in Annex 1, in comparison to the current approach.

a) Which product categories would potentially benefit by the setting of nutrient

6 In considering all costs for the purposes of this exercise, please exclude Business-As-Usual (BAU) costs.



-------------------------------------------------------------------------------------------


profiles at EU level? How would they benefit and why? Please identify which

product categories would benefit in comparison to the current approach.

b) What would be the main types of benefits for these product categories? Please

identify benefits, e.g. in terms of cost reduction, trade facilitation, market growth

opportunities etc.

c) To what extent can benefits be quantified? Please identify benefits that can be

quantified, either generically or on a specific product basis. Please prepare to

estimate and justify these benefits for later phases of the study.

d) Are there any benefits and/or opportunities that could be expressed in monetary

terms but cannot be quantified? Are there any other (non-monetary) advantages?

Can their relative importance be measured and how? Please identify potential

benefits and other non-monetary advantages that cannot be quantified, and suggest

alternative approaches for assessing the relative importance of these benefits. These

would describe the potential benefits and advantages of the setting of nutrient

profiles at EU level in terms of their ability to ensure:

o Accurate and reliable information for consumers?

o Free circulation of goods within the internal market?

o Legal certainty / fair competition for operators?

o Promotion and protection of food innovation?

Note: the above identified costs and benefits of a harmonised EU approach (setting of

nutrient profiles at EU level) would conversely become the benefits and costs of the

absence of harmonisation (i.e. the non setting of nutrient profiles at EU level). Please

highlight any cases where this logic does not apply.

5. To what extent are nutrient profiles at EU level still relevant and needed taking into

account the evolution of the market (Q2) and the evolution of the regulatory

framework (Q1), especially given the development of the nutritional information on

the front (logos, simplified nutrition declaration) and on the back (nutrition

declaration) of pack?

a) Are there any failures associated with the current non-setting of EU-nutrient

profiles? E.g. cases of products on which nutrition and health claims are used but

there may be issues with certain nutritional properties of the product, in particular

limiting claims on products high in fat, sugar and salt.

b) Are there differences in the incidence of such failures amongst Member States?

Please consider in particular any differences between Member States that have

national initiatives in place versus Member States that do not

c) What are the disadvantages/shortcomings of relying only on front and back nutrition

declaration for products bearing claims, versus the use of nutrient profiles as a

criterion for determining whether a product can bear claims?

d) Can other initiatives, such as the EU Platform on Diet, Physical Activity and Health

(e.g. EU Pledge) fill any gaps and problems identified due to the absence of EU

nutrient profiles? What are the disadvantages/shortcomings of relying on these

initiatives?



-------------------------------------------------------------------------------------------


2. Task 2: health claims made on plants and their preparations and the

general regulatory framework for their use in foods

Background

Regulation (EC) No 1924/2006 was originally intended to include also claims on plants and

their preparations used in foods; since it entered into force many claims on such products

were submitted to EFSA for assessment through the procedure under Article 13(1).

More than 500 claims on plants and their preparations have received an unfavourable

scientific assessment from EFSA. The main reason for this is that, as a general rule, EFSA’s

scientific assessments for health claims require evidence at the “highest possible standard”,

and EFSA considers human studies to be an essential part of this process. This implies that

evidence collected solely on the basis of experience gained over time through actual use is

not, on its own, deemed sufficient by EFSA to substantiate a health claim on plants and their

preparations used in foods. However, most of the dossiers on health claims on plants and

their preparations submitted to EFSA are actually based on the notion of "traditional use".

In September 2010, the decision was taken to put the authorisation of health claims on plants

and their preparations on hold. This applied both to already assessed claims, and to those

whose assessment was pending (EFSA was asked to discontinue their assessment): as a

result, a total of 1,958 health claims for plants and their preparations submitted under Article

13(1) are currently on hold. Health claims which are on hold can still be used under the

transitional measures foreseen in Article 28(5) of the Regulation. These claims must however

comply with the general principles and conditions of the Regulation, as well as with the

existing national provisions applicable to them. The Commission opted for the application of

a case-by-case approach to decide which claims in the consolidated list corresponded to

claims on plants and their preparations. “On hold” claims are currently used on commercial

products under the responsibility of food business operators, and have to comply with the

general principles of Regulation (EC) No 1924/2006 and with any existing national

provisions applicable to them, as well as with the overall regulatory framework applicable to

foods (including food supplements).

Given that health claims on plants and their preparations are currently on hold, and that parts

of Regulation (EC) No 1924/2006 have not been fully implemented, the purpose of the study

is to examine the current situation and to assess the extent to which the original provisions

remain adequate and necessary to achieve the objectives of the Regulation. One aspect that

will be investigated in the study is whether the scientific assessment of health claims could

recognise the notion of “traditional use” as an adequate element for the substantiation of a

claim, whilst ensuring that the objectives of the Regulation are met.

The study will also assess the potential changes in the market environment which could be

caused by the full entry into force of the relevant provisions of the Regulation, on one hand,

and by the lack of full implementation of the Regulation, on the other hand.

The results of the study will feed into the Commission’s reflection to decide whether there is

a need to review the current legislative framework applicable to plants and their preparations

used in foods with specific regard to health claims made on such products.



-------------------------------------------------------------------------------------------


The issue of health claims on plants and their preparations raised further concerns when a

number of Member States and stakeholders highlighted the overlap between Regulation (EC)

No 1924/2006 on health claims and Directive 2004/24/EC on traditional herbal medicinal

products (THMPs). In particular, there are two parallel legal frameworks applying to plants

and their preparations, while their classification is not easy, particularly for borderline

substances. Under the current EU rules, Member States may decide on the classification of a

product as food or as THMP on a case-by-case basis, taking into account all the

characteristics of the final product. In practice, as stated on several occasions by the Court of

Justice of the EU, differences exist between Member States in the classification of plants and

their preparations.

Such differences not only have implications for the approach to be applied to claims made on

such products (with different conditions of use depending on whether they are a food or a

THMP 7

), but more broadly for the overall safety and regulatory framework: when included

in foods, plants and their preparations also need to comply with the other relevant

requirements of EU food legislation. For plants and their preparations used in both foods and

medicines, differences in the applicable legislation and different approaches in the

classification among Member States could lead to different treatment of the same substance,

according to whether it is present in a food or in a medicine. This might create distortions on

the market, inconsistencies and lack of clarity for food business operators and Competent

Authorities, as well as cause confusion and safety concerns for consumers.

It is noted that the use of plants and their preparations in foods, including food supplements,

is not harmonised by means of specific legislation at EU level. Such food products are

covered by various Union legislative texts of general/horizontal application such as

Regulation (EC) No 178/2002 on the general principles of food law, and other legal acts

applicable to certain categories of foods, such as Regulation (EC) No 1925/2006 on the

addition of vitamins and minerals and of certain other substances to foods. Furthermore,

where there are no specific harmonised provisions, the principle of mutual recognition of

national rules applies, i.e. the free movement of such goods is governed by Articles 34 and 36

of the Treaty on the Functioning of the European Union (TFEU), subject to national

restrictions or bans within the limits laid down by Article 36.

Thus the study will investigate the impacts - on consumers, business operators and other

stakeholders - stemming from the absence of specific harmonised rules for the use of plants

and their preparations in foods, both with regard to claims made on such products and the

overall regulatory framework.

7 EU legislation on medicinal products includes provisions for the use of therapeutic indications based on

“traditional use” for certain THMPs, for which a special, simplified registration procedure is laid down in

Directive 2004/24/EC. Such products must fulfil certain conditions including that they are exclusively for

administration in accordance with a specified strength and posology. In this case, “traditional use” is defined as

medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15

years within the European Union. No provisions for “traditional use” exist in Regulation (EC) No 1924/2006.



-------------------------------------------------------------------------------------------


Questions

Note: the text in bold below indicates the main question and the sub-questions point to more detailed topics covered under the main question. Sub-questions in black indicate the main focus of the discussion during the workshop, while sub-questions in grey indicate the topics for which further data/feedback are requested from stakeholders.

We would like to discuss, and receive feedback and any available evidence from stakeholders

on the following aspects:

1. How has the regulatory framework relating to plants and their preparations used in

foods evolved at national (Member State) level in the absence of: i) the application of

Regulation (EC) No 1924/2006 on health claims for these products; and, ii) specific

harmonised legislation at EU level on the use of these products in foods? To what

extent are the current national approaches fragmented and diverse? Please provide

an overview of the situation across the EU, if possible providing additional information on

what you deem to be the most notable examples, particularly of contrasting/diverse

approaches, in your product sector.

a) To what extent have lists of health claims on plants and their preparations used in

foods been developed at national level? How diverse are such lists?

b) To what extent have positive or negative lists of plants and their preparations for use

in foods been developed at national level? How diverse are such lists?

c) Are there other forms of legal provisions (i.e. general legislation, specific

legislation, guidelines, recommendations etc.) dealing with plants and their

preparations used in foods? Are prior authorisation procedures in place at national

level? How diverse are such provisions?

d) Are there Member States planning to introduce any of the above elements, and/or

additional ones, in the regulatory framework relating to plants and their preparations

used in foods?

e) Why have initiatives emerged in some Member States and not in others? What are

the key drivers?

2. What are the main implications of the overlapping between different pieces of

legislation dealing with plants and their preparations? Please focus on the

overlapping of key relevant legislation (at EU and Member State level) dealing with

plants and their preparations used in foods, most notably Regulation (EC) No

1924/2006 on health claims, Regulation (EC) No 1925/2006 on the addition of

vitamins and minerals and of certain other substances to foods, and Directive

2004/24/EC on traditional herbal medicinal products ( THMPs).

a) To what extent have procedures and/or criteria been developed at national level in

the various Member States to classify products as a THMP or as a "food containing

plants or plant preparations"? How diverse are national approaches? Please provide

an overview of the situation across the EU, if possible providing additional

information on what you deem to be the most notable examples, particularly of

contrasting/diverse approaches, in your product sector. Please also identify which

products are more frequently involved in borderline cases (if any).

b) To what extent have the development of national approaches on product

classification, and potential differences in approaches between Member States,

affected the functioning of the EU and national markets in these products and



-------------------------------------------------------------------------------------------


consumer protection? Please consider what have been the impacts and note that

impacts need to be substantiated with fact-based evidence and quantitative elements

to the extent possible.

3. To what extent and how has the development of national approaches on the

regulatory framework for plants and their preparations used in foods (Q1 and Q2),

and potential differences in approaches between Member States, affected the

functioning of the EU and national markets for the different product categories? Please consider what have been the impacts, e.g. in terms of free circulation of goods

within the internal market, fair competition among operators etc., and note that impacts

need to be substantiated with fact-based evidence and quantitative elements to the extent

possible.

a) Which product categories are negatively affected by the non-application of

Regulation (EC) No 1924/2006 on health claims to plants and their preparations

used in foods?

b) What are the main types of costs8 for the affected product categories? Please

identify types of costs, e.g. in terms of cost increases, market loss etc.

c) To what extent can costs be quantified? Please identify costs that can be quantified,

either generically (i.e. for the product category as a whole) or on a specific product

basis. Please prepare to estimate and justify these costs for later phases of the study

d) Which product categories benefit by the non-application of Regulation (EC) No

1924/2006 on health claims to plants and their preparations used in foods?

e) What are the main types of benefits for these product categories? Please identify

benefits, e.g. in terms of consumer protection, public health , cost reduction, internal

market impact (trade facilitation, market growth opportunities) etc.

f) To what extent can benefits be quantified? Please identify benefits that can be

quantified, either generically or on a specific product basis. Please prepare to

estimate and justify these benefits for later phases of the study.

g) To what extent can any differences in market trends identified across Member States

be related to differences in specific regulatory and non-regulatory national initiatives

in this area (e.g. negative or positive lists, prior authorisation procedures)?

h) To what extent has the external trade of the EU with third countries been affected by

differences in specific regulatory and non-regulatory national initiatives in this area

(e.g. negative or positive lists, prior authorisation procedures)?

4. To what extent and how has the development of national approaches on the

regulatory framework for plants and their preparations used in foods (Q1 and Q2)

ensured a sufficient level of consumer protection? Can any specific adverse effects be

identified to emerge from potential differences in approaches between Member

States? Please consider what have been the impacts on consumer protection, and note

that impacts need to be substantiated with fact-based evidence and quantitative elements

to the extent possible.

5. What would be your initial view on the potential impact and how would you describe

potential advantages and disadvantages, in comparison to the current situation, of

either of the two scenarios described below:

8 In considering all costs for the purposes of this exercise, please exclude Business-As-Usual (BAU) costs.



-------------------------------------------------------------------------------------------


a) Scenario A: withdrawal of provisions on health claims made on plants and their

preparations used in foods from the scope of Regulation (EC) No 1924/2006. In

this scenario, would the impacts identified under Q2 to Q4, continue to be present?

Would different impacts emerge? If yes, which ones? Please explain the reasoning

behind the potential impacts that you have identified.

b) Scenario B: full application of Regulation (EC) No 1924/2006 on plants and

their preparations used in foods. Please consider potential impacts in terms of

consumer protection, free circulation of goods within the internal market and fair

competition among operators.

o What would be the main advantages? Which product categories would be

positively affected in this scenario? Why and how?

o What would be the main disadvantages? Which product categories would be

positively affected in this scenario? Why and how?



-------------------------------------------------------------------------------------------


Annex 1

Note: The text below outlines the main elements of the proposal setting nutrient profiles for foods bearing nutrition and health claims, as drafted by the Commission in 2009, pursuant to Article 4 of the Regulation (EC) No 1924/2006. For the purposes of the present analysis, this proposal serves as the baseline for analysing impacts in the context of this study.

Based on the EFSA’s scientific opinion on setting of nutrient profiles in 2009, and

consultations with Member States and different stakeholders, the Commission has examined

the different options for setting nutrient profiles and, in its draft proposal, identified the

preferred approach for the following important factors that need to be taken into account to

establish the system of nutrient profiles:

1. The scope of nutrient profiles;

2. Nutrient profile model: methodology and number of nutrients included in the profile;

3. The reference quantity for the nutrient profiles;

4. Levels of relevant nutrients to establish whether a product can bear a health claim.

These factors are summarised below as follows:

1. Scope of nutrient profiles

Nutrient profiles are set out generally, but adapted for a number of limited categories of

foods. This option takes into account the nutritional qualities of different food categories and

their impact in our diet. Under this option, the healthiest foods within a specific food category

are eligible to bear health claims.

Foods for specific purposes (food supplements and dietetic foods9), fruit and vegetables

without added salt, sugars and fats (including juices) are exempted from compliance with

nutrient profiles.

2. Nutrient profile model

The implementation of a threshold approach to establish nutrient profiles has been chosen.

Under this option, thresholds (maximum levels) of selected nutrients are established within

each category of foods. Products within specific categories10

have to meet these thresholds in

order to be eligible to bear a health claim. The thresholds are to be applied for sugar; sodium

(salt) and saturated fat as it is proven scientifically that excessive intake of these nutrients

have adverse effects on health.

3. Preferred approach for establishment of reference quantity

The reference quantity to evaluate the content of nutrients in foods is in g per 100 g/100 ml,

except when specified otherwise.

9 Dietetic foods include infant formulae and follow-on formulae, foods for infants and young children, foods

intended for use in energy-restricted diets, dietary foods for special medical purposes. 10

For a product to be considered as falling within a food category, at least 50% of the product’s ingredients

must be from the identified food category



-------------------------------------------------------------------------------------------


4. Preferred approach for levels of relevant nutrients to establish whether a product

can bear a health claim

Thresholds of selected nutrients which foods must comply with in order to bear health claims

Food categories saturated fat sugars sodium

Vegetable oil and spreadable fats 30 kcal/100g - 500 mg/100g

Fruit, vegetables,

seeds and their

products, except

oils

Fruit, vegetables and their

products, except oils

5 g/100 g 15 g/100g 400 mg/100g

Seeds and their products

except oils

10 g/100 g 15 g/100 g 400 mg/100 g

Fish and fishery products, crustaceans and

molluscs

10 g/100g - 700 mg/100g

Meat and meat products 5 g/100g - 700 mg/100g

Dairy products Dairy products except

cheese

2,5 g/100g 15 g/100g 300 mg/100g

Cheeses 10 g/100 g 15 g/100g 600 mg/100g

Cereal and cereal

products

Cereal and cereal products,

other than breakfast cereals

5 g/100g 15 g/100g 400 mg/100g

Breakfast cereals 5 g/100g 25g/100g 500 mg/100g

Breads containing at least 3

g of fibre per 100 g or at

least 1,5 g of fibre per 100

kcal

5 g/100g 15 g/100 g 700 mg/100g

(until date of

adoption + 6

years) 400

mg/100 g from

date of adoption +

6 years

Ready meals, soups, sandwiches 5 g/100g 10 g/100g 400 mg/100g

Non alcoholic beverages - 8 g/100g -

Other Foods 2 g/100g 10 g/100g 300 mg/100g



-------------------------------------------------------------------------------------------


Acronyms and abbreviations

The following acronyms and abbreviations are used in this working document:

o BAU: Business-As-Usual (costs)

o CA/s: Competent Authority/ies

o COM: European Commission

o DG SANTE: Directorate General Health and Consumers

o EEN: Europe Enterprise Network

o EFSA: European Food Safety Authority

o EU: European Union

o ‘food law’: means law governing any stage of production, processing and distribution

of food, including plants and their preparations and food supplements

o FCEC : Food Chain Evaluation Consortium

o GFL: General Food Law (Regulation (EC) No 178/2002)

o MS: Member State/s

o MS CAs: Member State Competent Authority/ies

o PAFF: Standing Committee on Plants, Animals, Food and Feed

o REFIT: the European Commission's Regulatory Fitness and Performance programme

o SMEs: Small and Medium size Enterprises

o TFEU: Treaty on the Functioning of the European Union

o THMP(s): traditional herbal medicinal product(s).

o ToR: Terms of Reference of the study

o WG: Working Group

WORKSHOP ON REGULATION (EC) N 1924/2006 · 1 COM(2015) 215 final. Communication from the Commission...

Documents

Transcript of WORKSHOP ON REGULATION (EC) N 1924/2006 · 1 COM(2015) 215 final. Communication from the Commission...