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
Date: 2013-04-23
Institutions: European Commission
Subjects: baby food, care of mothers and infants, early childhood, health care, human nutrition

EUROPEAN 
COMMISSION 

Brussels, 23.4.2013  
COM(2013) 241 final 

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

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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. 

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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/EC1.  

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 

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). 

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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 

the  European  Parliament  agreed  with 

Foods  for  weight  reduction: 
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 

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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. 

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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  178/20022,  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  1049/20013.  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-

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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. 
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. 

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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 consumers4 (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  foods5.  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 

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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. 
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. 

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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 foods6. 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 

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. 

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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 

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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 subject7. 

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 

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. 

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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  1272/20088  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. 

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. 

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