The Commission supports the position of the Council
at first reading adopted on 22 April 2013 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.
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 Commission Communication on action
taken on legislative opinions and non-legislative resolutions
adopted by Parliament at its June part-session (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.
The Commission considers that the common position
adopted by 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.
The main amendments of the European Parliament
accepted by the Commission and incorporated in full or in part in
the Council's position include:
- the inclusion in the scope of the Regulation of 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. An unambiguous
description of products for low-calorie diets is given in the
recitals;
- the obligation of the Commission to prepare a report
on milk-based drinks and similar products intended for young
children in the two years following the entry into
force;
- the introduction of provisions on the use of
pesticides, including foods for infants and young
children;
- the use of pictures in labelling of follow-on
formula;
- the adoption by the Commission of technical guidance
to facilitate compliance of food business operators, in particular
SMEs, with the requirements of the Regulation;
- the introduction of a cross-reference to the relevant
provisions of Regulation (EC) No 178/2002, regarding the
application of the precautionary principle.
The European Parliament's amendments rejected by the
Commission and incorporated in full, in part, in the Council's
position include:
- the inclusion, as an Annex to the Regulation, of the
Union list of authorised substances;
- the establishment of specific criteria for the
evaluation of nanomaterials and their inclusion in the Union
list of authorised substances, including with regard to the test
methods for evaluating their safety;
- the inability to change the definitions by
means of delegated acts, as they are essential elements of
Regulation;
- the possibility for the Commission to adopt
delegated acts for a period of five years tacitly extended in
the absence of opposition.
Certain amendments accepted by the Parliament and
rejected by the Commission have not been included in the first
reading Council position. These
amendments sought to:
- clarify that foods for special medical purposes
could fall under three different categories;
- include foods for people intolerant to gluten
in the scope of the Regulation;
- include formula for low birth weight and pre-term
infants in the scope of the regulation as a sub-category of
foods for special medical purposes;
- provide a temporary authorisation procedure for
innovative products;
- ask the Commission to draft a report, accompanied, if
necessary, by a legislative proposal to clarify the legal status of
indications of "Lactose free" and "very low
lactose".
The Commission accepts the new provisions introduced
by the Council as regards:
- the drafting of a report by the Commission on the
necessity, if any, of specific rules for foods intended for
sportsmen with the possibility to accompany this report with a
legislative proposal;
- the adoption by the Commission of implementing
measures to decide whether a food falls within the scope of the
Regulation and under what category;
- the introduction of a transition period of three
years plus exhaustion of stocks,
- the deletion of rules on emergency
measures.
The Commission states that it will pay particular
attention to pesticides containing
active substances, safeners or synergists classified in accordance
with Regulation (EC) No 1272/2008 as mutagen category, carcinogen
category, toxic for reproduction category, 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.