# EUR-Lex - 52013PC0241 - EN

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# 52013PC0241

**COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council at first reading with a view to the adoption of a Regulation of the European Parliament and of the Council on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control /* COM/2013/0241 final - 2011/0156 (COD) */**

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2011/0156 (COD)

COMMUNICATION FROM THE COMMISSION
TO THE EUROPEAN PARLIAMENT
pursuant to Article 294(6) of the Treaty on the Functioning of the European
Union
concerning the

position of the Council at first reading with
a view to the adoption of a Regulation of the European Parliament and of the
Council on food intended for infants and young children, food for
special medical purposes and
total diet replacement for weight control

1.           Background

Date of transmission of the proposal to the European Parliament and to the Council (document COM (2011) 353 final – 2011/0156 COD): || 24 June 2011

Date of the opinion of the European Economic and Social Committee: || 26 October 2011

Date of the position of the European Parliament, first reading: || 14 June 2012

Date of transmission of the amended proposal: || [*]

Date of adoption of the position of the Council: || 22 April 2013.

*       Taking into account the developments
in the informal discussions between the Council and the European Parliament
following the European Parliament first reading, the Commission did not prepare
an amended proposal but expressed its views on the Parliament amendments in the
"Communication de la Commission sur les suites données aux avis et
résolutions adoptés par le Parlement eropéen lors de la session de juin 2012"
(document SP (2012)540) sent to the European Parliament on 12 July 2012.

2.           Objective of the
proposal from the Commission

The proposal revises the framework legislation applying to
foodstuffs for particular nutritional uses, so-called 'dietetic foods', as set
out in Directive 2009/39/EC[1].

Taking into account the evolution of the food market and the
corresponding evolution of EU food law over the last decades, the proposal for
a Regulation abolishes the broad concept of 'foodstuffs for particular
nutritional uses', which dates back to 1977 and has led to problems for
stakeholders and controlling authorities in an evolved market and legal
context. It provides for a new framework establishing general provisions only
for a limited number of categories of foods that are considered as essential
for certain vulnerable groups of the population i.e. infants and young children
and people under medical supervision.

The proposal also foresees the establishment of
a single Union list of certain categories of substances (e.g. vitamins,
minerals, amino acids ...) that may be added to the categories of food covered by
the proposal. This Union list consolidates different lists currently foreseen
by different measures adopted by the Commission under the existing legal
framework for foodstuffs for particular nutritional uses.

The proposal pursues the objectives of better
regulation, since it maintains specific rules for products only where these are
necessary to protect vulnerable groups of the population, and simplifies the
current legislation by removing rules that have become unnecessary or
contradictory and by bringing together the different lists of substances that
may be added to these products.

3.           Comments
on the position of the Council

3.1.        General comments

The Commission's proposal was transmitted to the
European Parliament and to the Council on 24 June 2011. The European Parliament
adopted its position at first reading on 14 June 2012 and supported the main
goals of the Commission's proposal. In particular, the European Parliament
agreed on the need to abolish the concept of food for particular nutritional
uses itself as well as on the need to limit the scope of the legislation only
to certain categories of foods intended for vulnerable
groups of the population. The position of the European Parliament included 83 amendments to the original Commission's proposal.

No modified Commission's proposal was issued. In
the "Communication de la Commission sur les suites données aux avis et
résolutions adoptés par le Parlement européen lors de la session de juin 2012"
(document SP (2012) 540) sent to the European Parliament on 12 July 2012, the
Commission indicated that it could accept in full, in part, in principle or
subject to rewriting 53 of the 83 amendments, as it considered that these
amendments could clarify or improve the Commission's proposal and were
consistent with its general aims.

Following adoption of the European Parliament's
first reading position, informal discussions continued between the delegations
of the European Parliament, the Council Presidency and the Commission, with a
view to concluding an agreement at the common position stage ('early second
reading agreement').

These discussions proved successful and are
reflected in the common position of the Council, which was adopted with
qualified majority. The Commission considers that the common position of the
Council reflects the original goals of the Commission's proposal and takes into
account many concerns of the European Parliament. Although on certain elements,
the common position differs from the Commission's original proposal, the
Commission considers that it represents a carefully balanced compromise and is
satisfied that it covers all issues considered essential by the Commission when
adopting its proposal.

3.2.        Amendments of the European Parliament accepted by the Commission and
incorporated in full, in part or in principle in the position of the Council at
first reading

Foods for weight reduction: the European Parliament agreed with the Commission's proposal to
transfer the existing rules on meal replacement products for weight control
under Regulation (EC) No 1924/2006 on nutrition and health claims made on
foods. However, it adopted amendments to include in the scope of the Regulation
total diet replacement products for weight control, including Very Low Calorie
Diet products (VLCDs), which also replace the totality of the daily diet but
have a lower energy content (amendments 1, 11, 12, 20, 22, 26, 36, 46). The
European Parliament also set detailed rules for these products in the basic act
(amendments 71, 82).

In its Communication on the European
Parliament's position at first reading, the Commission accepted the principle
of including such products in the scope of the Regulation, in a spirit of
compromise. However, it explained that detailed rules should not be included in
the basic act. They should on the contrary be established by a delegated act
adopted in the framework of the Regulation as it is the case for all other
foods in the scope.

The Council's position is in line with the
Commission's, since meal replacements are left out of the scope, total
diet replacement products, including VLCDs, are in the scope, and it is
foreseen that specific rules for these products will be adopted by delegated
acts. A clear description of VLCDs is provided in the recitals, and that goes
in the direction of the European Parliament's concerns as represented in its
amendments. The Council's position is acceptable by the Commission.

Milk-based drinks and similar products
intended for young children: in its first reading
position the European Parliament adopted amendments 21 and 81 requiring the
Commission to adopt a report on milks intended for young children (so-called
'growing up milks'). The report, to be based on the advice of the European Food
Safety Authority, should assess the need for special provisions for these
products.

The Commission agreed with the European
Parliament on the usefulness of a report based on the scientific advice of the
European Food Safety Authority, especially taking into account that different
views exist on whether these products are needed or not to satisfy the
nutritional requirements of young children. The Council also agrees with the
European Parliament and proposes a drafting which requires the Commission to
draft a report on these products as required by the European Parliament, within
two years from the entry into force of the Regulation. The Council requests the
Commission to consider in the report, among others, the nutritional
requirements of young children, the role of these products in the diet of young
children and whether these products have any nutritional benefits when compared
to a normal diet for a child who is being weaned.

The request for a report, as drafted by the
Council, is acceptable for the Commission.

Pesticides: the European
Parliament proposed in its first reading position amendments to introduce in
the basic act detailed provisions on the use of pesticides, in particular as
regards food intended for infants and young children (amendments 15, 16, 17,
62, 63). These provisions focused, among others, on the importance, when
implementing the legislation, to restrict as far as possible use of pesticides
in products intended for the production of food covered by the Regulation, to
update measures in the area regularly and to pay particular attention to
certain pesticides containing dangerous active substances, safeners or
synergists, with the objective to ultimately avoid their use.

The Council introduces similar amendments going
in the direction of those by the European Parliament. However, the Council did
not include in its amendments reference to the fact that, when implementing the
legislation, the objective should be to ultimately avoid the use of certain
pesticides containing dangerous active substances, safeners or synergists.

The Commission had accepted partly, in
principle or subject to rewording, the amendments of the European Parliament.
In this context, it should be noted that the Commission's proposal foresaw the
possibility for the Commission to set where necessary specific rules on
pesticides in the delegated acts covering products in the scope of the
Regulation, and that legislation on pesticides has been recently reviewed and
takes into account vulnerable groups (including children, foetuses and
embryos). Therefore the Commission could be flexible to refer to the use of
pesticides as long as it is consistent with the existing rules on pesticides.
The Commission supports the Council's position on the subject, and considers
that it represents a good compromise accommodating the major concerns of the
European Parliament. In addition, the Commission also refers to the statement
made in attachment.

Use of pictures in labelling of follow-on
formula: the Commission had accepted in principle
amendment 59 by the European Parliament to extend to
the labelling of follow-on formulae the existing restrictions on labelling of
infant formula as regards the prohibition to use pictures of babies, text, etc.
idealising the use of the product. The Commission underlined however that such
rules would sit better in the context of the relevant delegated act.

The Council, in its position, agrees with the
European Parliament and proposes amendments in this direction. Further, it
proposes to accompany this requirement with the general principle that the
labelling, presentation and advertising of infant formula and follow-on formula
shall be designed not to discourage breast-feeding.

The Commission acknowledges that due to the
political importance of this provision, it is opportune to include it in the
basic act, as proposed by both co-legislators, and considers the Council's
position acceptable.

Technical guidance: the European Parliament had introduced amendments 30 and 72
requiring the Commission to adopt guidelines through delegated acts to
facilitate compliance of food business operators, in particular SMEs, with the
requirements of the Regulation. The Commission accepted these amendments in
principle.

The Council position foresees the possibility
for the Commission to adopt technical guidance but does not require this to be
done by delegated acts. The Commission accepts the position of the Council.

Precautionary principle: the European Parliament had introduced amendments 9, 10, 53,
64, 69 to reiterate that the precautionary principle, as set out in the General
Food Law Regulation (EC) No 178/2002[2],
is applicable when taking risk management measures relevant for the food
covered by this Regulation. The Commission accepted some of the amendments in
principle, in a spirit of compromise. In order to accommodate the European
Parliament's concerns, the Council introduces in its position a cross-reference
to the relevant requirements in Regulation (EC) No 178/2002. Considering the
horizontal nature of Regulation (EC) No 178/2002, the Commission prefers a
cross-reference that would guarantee better consistency of EU rules and
therefore supports the Council's position.

Access to documents: the European Parliament, in its position, introduced
amendment 76 to guarantee fair access to documents in line with the rules of
Regulation (EC) No 1049/2001[3].
This amendment was partly accepted by the Commission and is accepted with
redrafting by the Council. The Council's position is acceptable as it
cross-refers to Regulation (EC) No 1049/2001 thus ensuring consistency of EU
rules.

3.3.        Amendments of the European Parliament rejected by the Commission and
incorporated in full, in part or in principle in the position of the Council at
first reading

Union list of substances: the Commission's proposal foresaw the establishment of a Union list
of certain categories of substances (e.g. vitamins, minerals, amino acids...) that
may be added to the categories of food covered by the Regulation. In the Commission's
proposal this list had to be established and updated by implementing acts on
the basis of established criteria set in the basic act.

In its position, the European Parliament
proposed that this Union list of substances should constitute an Annex to the
Regulation and that it should be established and updated by delegated acts
(amendments 22, 87, 88, 89). The European Parliament's amendments left the
Annex empty and to be filled in by the Commission after adoption of the
Regulation. These amendments were rejected by the Commission, since it was
considered that, in accordance with the rules of the Treaty on the Functioning
of the European Union, the establishment and update of a list of well-defined
categories of substances on the basis of criteria set in the basic act should
be done by implementing acts.

In its position, the Council accepts the
European Parliament's position that the Union list should constitute an Annex
of the Regulation. However, the Council does not leave the Annex empty for future
adoption by the Commission, but establishes the Union list by itself, including
in this Annex all the substances belonging to certain categories of substances
(e.g. vitamins, minerals, amino acids...) that may be added to the categories of
food covered by the Regulation. Furthermore, the Council agrees with the
European Parliament that amendments to the Union list (in terms of categories
covered or substances included) should be done by delegated acts, but redrafts
the relevant Articles of the Regulation in light of the change in the nature of
powers delegated to the Commission.

The Commission understands that, given the
vulnerability of the categories of the population that are the consumers of the
food covered by the Regulation, the legislator wants to decide by itself what
substances should be included in the Union list. The Commission can therefore
accept that the Union list of substances is established by the legislator in
Annex to the Regulation. The Commission can also accept that modifications to the
Annex should be done by delegated acts, since the drafting in the Council's
position leaves the necessary large discretion to the Commission when adopting
such measures, in line with the nature of delegated acts as set out in the
Treaty on the Functioning of the European Union.

Nano-materials: the
European Parliament adopted amendment 87 requiring specific criteria for the
evaluation and inclusion of substances that are engineered nano-materials in
the Union list, in particular with respect to the test methods for evaluating
their safety. The European Parliament also introduced a cross-reference to the
definition of 'engineered nanomaterial' provided in Regulation (EU) No
1169/2011 on the provision of food information to consumers[4] (amendment 41). The Commission
rejected these amendments considering that the European Parliament's concerns
were adequately addressed by the Commission's proposal and that these
amendments were therefore not necessary.

The Council, in its position, includes, with
different drafting, the amendments of the European Parliament. It also redrafts
the proposal to clarify the interaction between the Regulation and Regulation
(EC) No 258/97 on novel foods[5].
The Council's position can be accepted by the Commission, in the spirit of compromise,
and taking into account that consistency is ensured with other pieces of EU
legislation.

Amendment of definitions: the Commission's proposal foresaw the possibility to adapt
the definitions of food covered by the Regulation on the basis of delegated
acts, taking into account technical and scientific progress and relevant
developments at international level, as appropriate.
This was also proposed in order to facilitate the resolution of future possible
borderline cases with respect to food covered by this Regulation. Both
the European Parliament and Council agree that definitions are essential
elements of the proposed Regulation and therefore cannot be modified by
delegated acts.

While the Commission had originally rejected
amendment 48 by the European Parliament, it can now accept the one by the
Council, in the spirit of compromise and taking into account the introduction
by the Council of a new Article in the proposal on interpretation decisions
(see below under 3.6).

Delegation of powers to the Commission: the European Parliament's (amendment 77) and Council's positions foresee
that the power to adopt delegated acts is conferred on to the Commission for a
period of five years which is tacitly extended in absence of opposition,
instead of an indefinite period as originally proposed by the Commission. The
Commission can accept this in a spirit of compromise and considering that both
co-legislators are requiring it.

3.4.        Amendments of the European Parliament accepted by the Commission in
full, in part or in principle, but not incorporated in the position of the
Council at first reading

Different categories of food for special
medical purposes: the European Parliament had
adopted amendment 47 which clarified that food for special medical purposes can
fall into three different categories (i.e. nutritionally complete food with
standard nutrient formulation; nutritionally complete food with a
nutrient-adapted formulation; nutritionally incomplete food with a standard or
nutrient adapted formulation). While the Commission had accepted this amendment
in principle, the Council did not include it in its position.

The Council's position is however acceptable
for the Commission, since the distinction between the three different
categories of food for special medical purposes is already present in the
existing legislation and will be established in the relevant delegated act.
Inclusion of this level of detail into delegated acts will also ensure the
necessary flexibility if such categories would need modification in the future.

3.5.        Amendments of the European Parliament rejected by the Commission and
not incorporated in the position of the Council at first reading

'Gluten-free' and 'very-low gluten' foods: the Commission originally proposed that rules on these products,
currently included in a specific Regulation adopted under the existing
Framework Directive on 'dietetic foods', should be kept as such but transferred
under Regulation (EC) No 1924/2006 on nutrition and health claims made on foods[6]. The European Parliament
proposed in its position (amendments 1, 11, 12, 20, 35, 44, 45, 70, 90) to add
food for people intolerant to gluten to the scope of the Regulation and
included specific rules in the basic act. This was rejected by the Commission
since it would be unnecessary and would not be in line with the objective of
better Regulation and simplification.

The Council did not incorporate the European
Parliament's amendments and established, on the contrary, that existing rules
applicable to these products should be transferred under Regulation (EU) No
1169/2011 on the provision of food information to consumers, through specific
procedures described therein. In a recital, the Council specifies that this
transfer should ensure at least the same level of protection for people who are
intolerant to gluten as currently provided for under the existing rules and
that it should be completed prior to the application of the Regulation.
Furthermore, the Council foresees that the Commission should consider how to
ensure that people who are intolerant to gluten are adequately informed of the
difference between food that is specially produced,
prepared and/or processed to reduce the gluten content of one or more gluten-containing
ingredients and other food that is naturally free of gluten.

The Commission supports the Council's position
that will not only guarantee the maintenance of the same level of protection
for consumers, but will also allow extending the existing rules to non
pre-packed foods, thus increasing consumers' protection. Furthermore, the
transfer of the rules under Regulation (EU) No 1169/2011, that already contains
rules on the mandatory indication of the presence of gluten-containing
ingredients, will be consistent with the principles of better Regulation and
guarantee that all rules related to gluten are covered by the same legal
framework.

Formula for low birth weight and pre-term
infants: the Commission did not accept the position
of the European Parliament (amendments 34, 43 and 92) that formulae for low
birth weight and pre-term infants should be included in the scope of the
Regulation as a sub-category of food for special medical purposes and that, in
all cases, such formulae should comply both with the requirements applicable to
food for special medical purposes and those applicable to standard infant
formulae. The Council acknowledged in its position that a reflection should be
carried out on what rules applicable to standard infant formulae and follow-on
formulae should also apply to foods for special medical purposes for infants,
with a view to a possible extension of the rules applicable. However, it
adopted amendments leaving it for the Commission to do so in the context of
delegated acts.

The Council's position is acceptable for the
Commission. Indeed, not all low birth weight and pre-term infants need food for
special medical purposes, and a decision on the nutritional requirements of low
birth weight or pre-term infants needs to be taken on a case by case basis.
Similarly, not all rules applicable to infant formula should apply to formula
for low birth weight and pre-term infants, as a certain degree of flexibility
is needed.

When adopting specific rules for food for
special medical purposes via delegated acts, the Commission will have the
possibility to consider what rules should apply to food for special medical
purposes for infants, taking into account the developments in the market and
the notable increase of the offer related to such products. The Commission
considers that the Council's drafting takes into account the European
Parliament's concerns, since it clearly foresees that the Commission will have
to consider the issue when adopting delegated acts.

Innovation: the Council
does not incorporate in its position amendments 31, 50 and 91 of the European
Parliament that relate to a temporary authorisation procedure for innovative
products. The European Parliament's amendments aimed at allowing innovative
products not complying with the composition requirements as laid down in the
delegated acts adopted under the Regulation to be placed on the market for two
years.

The Council considers the Commission's proposal
in this respect sufficient, since the latter foresees the possibility to modify
by delegated acts composition requirements for products covered by the
Regulation. However, the Council modifies the proposal by stressing that
amendments to such requirements should take into account all relevant data,
including data provided by interested parties in relation, among others, to
innovative products. The Commission accepts the Council's position which
strikes a fair balance between the support to innovation and the opportunity to
eliminate unnecessary rules and excessive administrative burden.

'Lactose-free' foods: the European Parliament proposed in its first reading position amendment
80 requesting the Commission to draft a report to clarify the status of
indications of "lactose free" and "very low lactose"
together with a legislative proposal if necessary. The Council, in its
position, suggests that these statements could be harmonised, if necessary,
under the rules of Regulation (EU) No 1169/2011 on the provision of food
information to consumers, as it is the case for gluten. A recital also makes
reference to the existing scientific advice provided by the European Food
Safety Authority on the subject[7].

The Commission considers that a report would
not be needed since the status of these indications is clear under general food
law, and scientific advice on the subject already exists. The Commission
accepts the Council's position which ensures consistency both with the
management of the rules on 'gluten-free' foods, and with the rules on the
mandatory indication of the presence of ingredients containing lactose, which
are also already required under Regulation (EU) No 1169/2011.

3.6.        New provisions introduced by the Council

Foods intended for sportsmen: the Commission originally proposed to leave sports foods out
of the scope of the proposed Regulation and to have them covered exclusively by
general food legislation (and in particular the Regulation on claims). The
European Parliament, in its first reading position, agreed with the Commission
that these products should fall out of the scope of the Regulation but called
on the Commission to "assess, not later than 1 July 2015, the need to
review general food law in this regard" (amendment 6).

The Council agreed in its position to leave
these products out of the scope of the proposed Regulation but introduced
amendments requiring the Commission to draft a report on the necessity, if any,
of specific rules for these products with the possibility to accompany this
report with a legislative proposal. The Council's request for a report can be
accepted in the spirit of final compromise, and especially taking into account
that the co-legislators agree that, in the meantime, these products should
remain out of the scope of the Regulation.

Interpretation decisions: the Council introduced in its position an Article allowing the
Commission to adopt implementing measures to decide whether a food falls within
the scope of the Regulation and under what category. The Commission considers
the Council's amendment to be a useful improvement of the proposal, which will
facilitate the implementation of the Regulation and will reduce the
difficulties related to borderline cases. Indeed, the difficult borderline
between foods currently considered as foods for particular nutritional uses and
'normal foods' was one of the reasons that convinced the Commission to present
the proposal.

Transition periods and repeal of existing
measures: the Council's position foresees a
transition period of three years plus exhaustion of stocks, instead of two
years plus exhaustion of stocks as proposed by the Commission. The Council also
proposes to extend this transition period for specific products in case the
Commission is late in adopting the relevant delegated acts. The Council's
position is acceptable in the context of the general compromise and also taking
into account the revised draft that improves clarity for operators and
controlling authorities.

Deletion of rules on emergency measures: the Council in its position deletes rules on emergency measures
since these are already included in Regulation (EC) No 178/2002 on general food
law. The Council's position is acceptable by the Commission.

4.           Conclusion

The Commission considers that the common position adopted by the
Council with qualified majority reflects the original goals of the Commission's
proposal and takes into account many concerns of the European Parliament.
Although on certain elements, the common position differs from the Commission's
original proposal, the Commission considers that it represents a carefully
balanced compromise and is satisfied that it covers all issues considered
essential by the Commission when adopting its proposal.

For the reasons outlined above the Commission
supports the common position adopted on 22 April 2013.

5.           Statement
by the Commission on pesticides

In implementing Article 11(1)(b), the
Commission will pay particular attention to pesticides containing active
substances, safeners or synergists classified in accordance with Regulation
(EC) No 1272/2008[8]
as mutagen category 1A or 1B, carcinogen category 1A or 1B, toxic for
reproduction category 1A or 1B, or considered to have endocrine disrupting
properties that may cause adverse effects in humans, or which are very toxic,
or which cause critical effects such as developmental neurotoxic or immunotoxic
effects, with the objective to ultimately avoid their use.

[1]               Directive 2009/39/EC of the European Parliament and
of the Council of 6 May 2009 on foodstuffs intended for particular nutritional
uses (OJ L 124, 20.5.2009, p. 21–29). Under that framework legislation, a
series of specific measures were adopted by the Commission. More specifically, Commission
Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on
formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1–33);
Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based
foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p.
16–35); Commission Directive 96/8/EC of 26 February 1996 on foods intended for
use in energy-restricted diets for weight reduction (OJ L 55, 6.3.1996, p.
22–26); Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for
special medical purposes (OJ L 91, 7.4.1999, p. 29–36); Commission Regulation
(EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of
foodstuffs suitable for people intolerant to gluten (OJ L 16, 21.1.2009, p.
3–5); Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances
that may be added for specific nutritional purposes in foods for particular
nutritional uses (OJ L 269, 14.10.2009, p. 9–19); Council Directive 92/52/EEC
of 18 June 1992 on infant formulae and follow-on formulae intended for export
to third countries (OJ L 179, 1.7.1992, p. 129–130).

[2]               Regulation (EC) No 178/2002 of the European
Parliament and of the Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety, OJ L 31,
1.2.2002, p. 1–24.

[3]               Regulation (EC) No 1049/2001 of the European
Parliament and of the Council of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents, OJ L 145, 31.5.2001, p.
43–48.

[4]               Regulation (EU) No 1169/2011 of the European
Parliament and of the Council of 25 October 2011 on the provision of food
information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No
1925/2006 of the European Parliament and of the Council, and repealing
Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission
Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of
the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission
Regulation (EC) No 608/2004, OJ L 304, 22.11.2011, p. 18–63.

[5]               Regulation (EC) No 258/97 of the European Parliament
and of the Council of 27 January 1997 concerning novel foods and novel food
ingredients, OJ L 43, 14.2.1997, p. 1–6.

[6]               Regulation (EC) No 1924/2006 of the European
Parliament and of the Council of 20 December 2006 on nutrition and health
claims made on foods, OJ L 404, 30.12.2006, p. 9–25.

[7]               EFSA Panel on Dietetic Products, Nutrition and
Allergies (NDA); Scientific Opinion on lactose thresholds in lactose
intolerance and galactosaemia. EFSA Journal 2010; 8(9):1777. [29 pp.].
doi:10.2903/j.efsa.2010.1777.

[8]               Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008 on classification, labelling
and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, p. 1–1355.