Explanatory Memorandum to COM(2011)353 - Food intended for infants and young children and food for special medical purposes - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2011)353 - Food intended for infants and young children and food for special medical purposes. |
|---|---|
| source | COM(2011)353  |
| date | 20-06-2011 |
· Grounds for and objectives of the proposal
The proposal revises the legislation on foodstuffs intended for particular nutritional uses covered by Directive 2009/39/EC the so-called 'Framework Directive on dietetic foods'. The provisions of Directive 2009/39/EC were originally adopted in 1977. After several amendments, a recast version was adopted in 2009 to include the rules of the new Comitology procedure.
Foodstuffs for particular nutritional uses are foods that are different from foods for normal consumption and are, as currently regulated, specially manufactured products intended to satisfy the particular nutritional requirements of specific categories of the population. The designation under which a dietetic food is sold is accompanied by a suitability statement for the particular nutritional use and the specific group of the population to whom the food is intended, e.g.: gluten-free food for celiac people, processed cereal-based food for young children, infant formulae for infants from birth etc.
After more than 30 years of application, the evolution of both the food market and food legislation makes an overall revision necessary. Indeed, the application of the broad concept of 'foodstuffs for particular nutritional uses' on which the Framework Directive is based in the evolved market and legal context has led to considerable problems for stakeholders and controlling authorities. The classification of many foods as dietetic foods and the need for such a category of foods has been seriously questioned, although the desirability of maintaining rules on certain specific categories of foods actually addressing nutritional benefits for certain sub-groups of the population is being recognised.
Consequently, in pursuing the objectives of better regulation and simplification, the proposal aims to rectify this situation by simplifying and clarifying the rules that apply to products hitherto regulated as dietetic foods, taking into account the evolution of the regulatory measures in relevant areas.
Given the above, the proposal abolishes the concept of dietetic foods and provides for a new framework establishing general provisions only for a limited number of well-established and defined categories of food that are considered as essential for certain vulnerable groups of the population, i.e. food intended for infants and young children and food for patients under medical supervision.
Further to these objectives, the proposal also aims at creating a single legal measure that regulates lists of substances such as vitamins, minerals and other substances that may be added to the categories of food covered by this proposal. The currently existing three different lists of substances included in three different legal measures would be combined into a single one. Clarity for stakeholders and Member States and better Union administration would be the outcome of the establishment of such a merged measure.
The revision of the legislation is accompanied by an impact assessment giving an overview of the application of Directive 2009/39/EC.
· General context
The main objective of the Framework Directive was to remove the differences between national laws relating to foodstuffs for particular nutritional uses, thus allowing their free movement and creating fair conditions of competitions.
Discussions with Member States and stakeholders have highlighted increasing difficulties for implementing the Framework Directive, in particular in relation to more recent pieces of Union legislation such as the legislation on food supplements (Directive 2002/46/EC), on the addition of vitamins and minerals and other substances to foods (Regulation (EC) No 1925/2006) and nutrition and health claims (Regulation (EC) No 1924/2006). In effect, as the food market evolved, so did the Union legislation governing it in order to ensure the functioning of the internal market and guarantee the same level of protection to citizens across Europe.
This unclear situation has led also to distortions of trade in the internal market due to different interpretation and enforcement of Directive 2009/39/EC across Member States and in particular regarding its scope of application. Furthermore, it appears that these more recently adopted Union legislations mentioned above would adequately cover all products addressing nutritional benefits for the general population and certain sub-groups thereof with less administrative burden and more clarity as to their scope.
As foreseen in the Framework Directive, Member States were asked for their views and experience on the implementation of certain provisions of that Directive in order to prepare Commission reports on 1) the implementation of the notification procedure of the Framework Directive on dietetic foods and 2) the desirability of special provisions for foods for persons suffering from carbohydrate-metabolism disorders (diabetic foods).
As regards foods for diabetic people, the Commission's report concludes that there is no scientific basis on which to develop specific compositional requirements for this category of food and that diabetic people should eat as healthily as possible choosing a diet from a variety of food for normal consumption. Also, the report on the implementation of the notification procedure points out that the category of food regulated under that provision differs significantly between Member States creating as a result market distortions. On top, a company is requested to notify to the competent authorities each product they want to market as a dietetic product and has to repeat that procedure in all the Member States where they wish to place the product on the national market. The resulting administrative burden is significant for both the Member States and the company while the added value in terms of public health and consumer information is questionable.
All abovementioned issues led to the need to consider an in depth and global revision of the legislation on dietetic foods.
· Existing provisions in the area of the proposal
The following pieces of legislation cover the area of foods for particular nutritional uses:
– Directive 2009/39/EC on foodstuffs intended for particular nutritional uses, 'the Framework Directive on dietetic foods'. The Directive lays down a common definition on foods for particular nutritional uses as well as general provisions (e.g. a general notification procedure for categories for foods not covered by specific Commission legislation) and common labelling rules.
According to the definition, foods for particular nutritional uses are foods that are different from foods for normal consumption and are specially manufactured products intended to satisfy the particular nutritional requirements of specific categories of the population.
Specific measures adopted for certain categories of foods under that framework legislation are:
– Commission Directive 2006/141/EC on infant formulae and follow-on formulae.
This Directive was adopted originally in 1991 and revised globally in 2006. It establishes detailed and complete compositional and labelling rules for products intended to infants from birth up to 12 months of age. Infant formulae are suitable as the sole source of nourishment during first months of life if infants are not breastfed while follow-on formulae may constitute the principal liquid element in a progressively diversified diet.
* Council Directive 92/52/EEC on infant formulae and follow-on formulae intended for export to third countries established the rules for infant formulae and follow-on formulae exported or re-exported from the European Union to third countries.
– Commission Directive 2006/125/EC on processed cereal-based foods and baby foods for infants and young children.
Directive 2006/125/EC was adopted originally in 1996 and was codified in 2006. This Directive covers foods that are intended to be part of a diversified diet of infants and young children. It lays down general compositional and labelling rules for a large diversity of products. No major changes have been introduced since its first date of adoption.
– Commission Directive 1999/21/EC on dietary foods for special medical purposes.
Dietary foods for special medical purposes are intended for the exclusive or partial feeding of patients with disturbed capacity to take ordinary food and whose dietary management cannot be achieved by modification of the normal diet or by other dietetic foods. It establishes general compositional criteria and quite detailed labelling rules. These foods are to be used under medical supervision. No updates have been made since 1999.
– Commission Directive 96/8/EC on foods intended for use in energy-restricted diets for weight reduction.
This Directive covers two categories of products intended for weight control: products presented as a replacement for the whole daily diet and products presented as a replacement for one or more meals of the daily diet.
It sets general compositional and compulsory labelling rules for these products.
– Commission Regulation (EC) No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten.
This Regulation was adopted in 2009. A transitional period applies until 1 January 2012. It fixes gluten thresholds and associated labelling rules for the voluntary indication of the absence of gluten in products for people suffering from a permanent intolerance to gluten (coeliac people). The Regulation foresees that the statement gluten-free can be used on foods for normal consumption as well.
– Commission Regulation (EC) No 953/2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses.
This Regulation adopted in 2009 updates and replaces Directive 2001/15/EC and established a consolidated list of substances such as vitamins, minerals, and other substances that may be used in dietetic foods except those that can be used in infant formulae and follow-on formulae and in cereal-based foods and other baby foods which are included in the relevant specific Directives. The addition of new substances to that list is subjected to the scientific assessment of the European Food Safety Authority (EFSA).
· Consistency with the other policies and objectives of the Union
The proposal is in line with the Commission's Better Regulation Policy, the Lisbon Strategy and the EU's Sustainable Development strategy. The emphasis is on simplifying the regulatory process, thus reducing the administrative burden and improving the competitiveness of the European food industry, while ensuring the safety of food, maintaining high level of public health protection and taking global aspects into consideration.
· Consultation of interested parties
There was a broad consultation of all interested parties seeking their views on the provisions and application of existing legislation and the need for change. The respondents were the competent authorities of the Member States, industry association representatives and consumer organisations.
– Consumer organisations main concern is that certain foods are unduly covered by special designation/status under the current Framework Directive which could put them out of the scope of other important provisions – e.g. Regulation on Nutrition and Health Claims. These stakeholders have highlighted that where there are no compositional or labelling requirements justified by specific nutritional needs and consumer protection there is no need to grant a special status to foods. This is especially the case when this status allows the food to bear a suitability statement that could be confused with a nutrition or health claim or make the food appear more appropriate than a similar normal food.
– The specialised dietetic food industry believes that clear and transparent legislation governing the composition of products for the dietetic food sector is essential to maintain the protection of vulnerable groups of the population and those with special nutritional needs from a public health and food safety perspective. In that context, they suggest to strengthen the current legislation and to include in a positive list at least the following groups of products: Foods for infants and young children up to the age of three - including Low Birth Weight Formula; Hospital Discharge Formula; Breast Milk Fortifier and Growing Up Milks; Foods for pregnant and lactating women; Foods for the elderly in good health; ‘Foods for weight management’; ‘Foods for special medical purposes’; ‘Foods for sportspeople’; ‘Dietary foods for people with gluten intolerance’; ‘Lactose-free foods’.
In addition, the dietetic food industry emphasises the need for a transparent, efficient and effective procedure for the expansion of the Union list. They argue that science still emerges in this area and therefore a flexible procedure must be offered to promote innovation.
Nevertheless, this position is not shared by all parts of the industry; certain others believe that the same rules should apply to all foods and that there is no reason to foresee different rules except in very limited cases, where nutritional food safety issues are concerned. For certain categories of foods, additional rules may result in unnecessary burden on the industry. In addition, they fear that a legal straight jacket may hamper innovation.
– Member States have reported that the legislation on dietetic foods is being used by some operators to circumvent the rules of subsequent food legislation such as the Regulation on claims, distorting the notion of a food for particular nutritional uses, and resulting, in certain cases, in confusion over its application that creates unfair competition between businesses and difficulties for enforcement.
Member States underline that the most important aspect to maintain would be consumer safety.
The Commission identified in its impact assessment supporting the proposal four options taking into account the aforementioned issues and compared them in light of the objectives of the revision (coherence, simplification, harmonisation and small businesses and innovation).
· Collection and use of expertise
There was no need for external expertise.
· Impact assessment
The Commission carried out an impact assessment which is presented in parallel to this proposal as a Commission Staff Working Paper.
Four different options have been considered ranging from repealing the legislation to establishing a reinforced legislation for dietetic foods. These options were assessed taking into account their economic, social and environmental impacts on the various stakeholders and authorities. In addition, a no-change scenario was considered as a reference against which to assess the possible impacts of the different options.
Two different approaches have been considered:
the notion of dietetic food is no longer needed to help the food market today and should be abolished;
the notion of dietetic food needs to be strengthened to bring it more into line with today's food market and consumers' needs.
The four options (two following approach (1) and two following approach (2)) considered within the Impact Assessment have been developed to ensure that none of them would result in the removal of products from the market but they may necessitate potential label changes and/or reformulation of products or have an impact on their market value. In other words, the options considered for the revision of the dietetic food legislation do not foresee any ban per se of foods currently sold as foods for particular nutritional uses. In addition, the proposed rules within each option would allow for market adaptation and therefore a sufficient transitional period is foreseen to help have a smooth transition to the new legislation and minimise economic burden.
Summary of the options and the key impacts under each of them:
· Option 1 – Repeal all the legislation on dietetic foods (Framework Directive and all the specific Directives adopted under that Framework)
Repealing the concept of dietetic food will prevent further distortions between dietetic foods with suitability statements and normal foods with nutrition and health claims. However, whilst such an option appears to be a good one in terms of simplification and reducing administrative burden, the trade off in terms of the introduction of national legislation to compensate the repeal of certain Union legislation (e.g. on foods intended for infants and young children) may be significant.
· Option 2 – Repeal the Framework Directive on dietetic foods but maintain certain of the specific rules adopted under that Framework
This option provides the same simplification and administrative burden reduction benefits as option 1 but also gives the Union the possibility to maintain for certain categories of foods, rules the harmonisation of which has provided added value at EU level. Having no general rules on dietetic foods anymore and clearer rules for certain specific products should ensure better coordination between the requirements of different pieces of legislation.
· Option 3 – Revision of the Framework Directive establishing a positive list of dietetic foods with specific compositional and/or labelling rules
The main advantage of setting a positive list for dietetic foods with specific compositional and labelling rules is that standardised rules would apply to the dietetic food sector ensuring harmonisation across the European Union. However, the burden that would fall on the industry and Member States for having to comply with additional specific dietetic food legislation to be able to target food to certain groups of the population may be considered disproportionate particularly taking into account the minimal additional public health and consumer information benefits.
· Option 4 – Amending the Framework Directive replacing the notification procedure with a centralised Union prior-authorisation procedure based on a scientific assessment
The application of a standard prior-authorisation procedure would ensure more harmonisation across the European Union than the general notification procedure currently in place. However, the burden of prior authorisation before using a dietetic suitability statement on a product seems to be disproportionate in terms of consumers' protection and information and would be highly costly for the industry and especially for SMEs.
The Commission proposal follows option 2 - Repeal the Framework Directive on dietetic foods but maintain certain of the specific rules adopted under that Framework.
Contents
· Summary of the proposed action
Adoption of a Regulation of the European Parliament and of the Council establishing rules applicable to foods intended for infants and young children and to foods for special medical purposes and concerning a Union list of substances which can be added to the foods covered by this proposal.
The proposal simplifies and clarifies legal requirements applying to certain categories of foods and establishes a single list of substances that may be added to the foods ('Union list') covered by this proposal. In particular, it:
– provides a new general Framework legislation applying to well-defined categories of foods that have been identified as essential for certain well-established groups of consumers with specific nutritional needs;
– establishes a clear and defined scope of application;
– maintains specific measures for categories of foods that are essential for certain groups of the population;
– lays down general rules as regards the composition and labelling applying to these categories of foods;
– removes differences in interpretation and difficulties for Member States and operators in applying different pieces of food legislation by simplifying the regulatory environment;
– removes the burdens associated with the notification procedure;
– ensures that similar products are treated in the same way across the Union;
– removes rules that have become unnecessary, contradictory and potentially conflicting;
– establishes a single legal measure for substances that can be added to the foods covered by this proposal;
The new proposal will repeal Directive 92/52/EC, Directive 2009/39/EC, Directive 96/8/EC and Regulation (EC) No 41/2009.
The specific compositional and information requirements will be laid down in delegated Regulations, adopted by the Commission, in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) taking into account the general requirements laid down in this proposal as well as Commission Directives 2006/141/EC, 2006/125/EC, and 1999/21/EC.
The adoption of the Union list implies the application of criteria set out in this proposal therefore implementing powers shall be conferred on the Commission in that respect. Those powers shall be exercised in accordance with Regulation (EU) No 182/2011.
Emergency procedures are foreseen in situations where food covered by this proposal constitutes a serious risk to human health. For this purpose, implementing powers shall be conferred on the Commission in that respect. Those powers shall be exercised in accordance with Regulation (EU) No 182/2011 of the TFEU.
· Legal basis
This proposal is based on Article 114 TFEU. This legal basis is justified both by the objective and the content of the proposal. Measures adopted under Article 114 TFEU should have as their object the establishment and functioning of the internal market. The proposal establishes a harmonised legal framework concerning the composition and information requirements for infant formulae and follow-on formulae, processed cereal-based foods and baby foods for infants and young children and foods for special medical purposes as well as a Union list of substances that can be added to such foods since it is necessary to keep a harmonized framework for products addressed to particular vulnerable parts of the population for which categories of food constitute the sole source of nourishment. The objective of the proposal is to avoid any differences between national laws relating to the categories of food at issue impeding their free movement and thus having a direct impact on the establishment and functioning of the internal market.
· Subsidiarity principle
The subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the Union.
The objectives of the proposal cannot be sufficiently achieved by the Member States for the following reason(s):
Prior to the adoption of the Framework Directive, the national measures in the Member States differed from one Member State to another. The differences between these laws obliged the dietetic food industry to vary their production according to the Member State for which the products were intended. To respond to this, general rules and a number of specific measures have been adopted at Union level.
In order to harmonise intra-union trade and trade with third countries the Union does have the right to act. However, this should be balanced against the proportionality of the measure and the added value Union rules will have for citizens across all Member States.
Individual action by Member States could lead to differing levels of food safety and protection of human health and confuse consumers. In addition, it would endanger the free movement of these foods in the Union.
The core of the Union action would maintain existing rules for certain products that are traded widely within the Union and where there is agreement amongst Member States for the continuing need for specific composition and labelling rules to ensure the free movement of these goods. It also aims to simplify the regulatory environment as regards the addition of substances to the foods covered by this proposal.
The proposal therefore complies with the subsidiarity principle.
· Proportionality principle
The proposal complies with the proportionality principle for the following reason(s):
The proposal harmonises the regulatory framework establishing general provisions applying to certain categories of foods where the need for additional compositional and labelling provisions to the general rules applying to all foods is demonstrated. Such additional provisions contribute to consumer protection by ensuring that consumers receive nutritionally adequate foods and appropriate information.
The proposed measures are sufficient in terms of reaching the objectives of ensuring that consumers make informed and safe choices and securing the smooth functioning of the internal market. At the same time they do not impose an excessive or unjustified burden.
The absence of harmonisation for these categories of foods would result in a proliferation of national rules resulting in different levels of consumer protection between the Member States and increased burden for the industry.
The financial burden is minimised as the current specific provisions exist already, the general provisions are only simplified and clarified as to their scope of application.
· Choice of instruments
Proposed instruments: Regulation.
Other type of measure would not be adequate for the following reason(s).
The existing framework is, in general, prescriptive with little flexibility for Member States in how it should be applied. A Directive would have lead to an inconsistent approach in the Union leading to uncertainty for both consumers and the industry. A Regulation provides a consistent approach for industry to follow and reduces the administrative burden as operators do not need to familiarise themselves with the individual national legislation in the Member States.
Soft law instruments such as guidelines would be a flexible approach to addressing certain changes needed in the current legislation but not all of them. In addition, due to the non-binding status such instruments are considered not sufficient to tackle differences in the interpretation and implementation of the legislation.
None.
· Simulation, pilot phase and transitory period
There will be a transitory period for the application of the proposal.
· Simplification
The proposal provides for simplification of legislation. This is one of the main objectives of the revision of the legislation on foods for particular nutritional uses.
The use of a Regulation as the legal instrument supports the objective of simplification because it guarantees that all actors have to follow the same rules at the same time.
National administrative procedures following the implementation of the general notification procedure will be abolished reducing the administrative burden associated with the implementation of the legislation.
The provisions adopted in and under Directive 2009/39/EC that have become unnecessary, contradictory and potentially conflicting will be removed.
The proposal is included in the Commission Working Programme for 2011 – Annex III – Simplification Rolling Programme and Administrative Burden Reduction initiatives under the reference 2009/SANCO/004.
· Repeal of existing legislation
The adoption of the proposal will lead to the repeal of existing legislation.
· Recasting
The proposal involves recasting.
· European Economic Area
The proposed act concerns an EEA matter and should therefore extend to the European Economic Area.
· Detailed explanation of the proposal
The Regulation provides the basis for the assurance of a high level of consumer protection in relation to foods intended for infants and young children and to foods for special medical purposes. It establishes also a single legal measure that regulates the list of substances that can be added to the foods covered by the proposal (Chapter I).
Chapters II and III provide for general principles and specific provisions that shall apply to infant formulae and follow-on formulae, processed cereal-based foods and baby foods for infants and young children and foods for special medical purposes.
Chapter IV relates to the establishment of a Union list of substances that can be added to the foods covered by the proposal and provides for a procedure for updating the Union list.
Chapter V provides for a general confidentiality clause.
Chapter VI and VII concerns all the procedural provisions related to the implementation of the new proposal, the delegation of powers, the procedures, the necessary amendments and the measures that are to be repealed. It specifies also the transitional measures that would apply to the categories of foods currently regulated under Directive 2009/39/EC and the date of entry into force and application.