Explanatory Memorandum to COM(2013)894 - Novel foods - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)894 - Novel foods. |
|---|---|
| source | COM(2013)894  |
| date | 18-12-2013 |
· Grounds for and objectives of the proposal
This proposal aims to ensure food safety, to protect public health and secure the functioning of the internal market for food, while supporting innovation for the food sector.
It aims to streamline the authorisation procedure, to improve its efficiency and transparency. It clarifies the definition of a novel food, including new technologies which have an impact on food.
It introduces a faster and more proportionate safety assessment for traditional foods from third countries having a history of safe food use.
The general criteria for the Novel Food definition remain unchanged: novel foods are foods and food ingredients which were not consumed in the EU to a significant degree before the entry into force (15 May 1997) of the current Novel Food Regulation.
· General context
On 14 January 2008, the Commission adopted a proposal for a Regulation of the European Parliament and of the Council on Novel Food.
The legislative discussions under the Ordinary legislative procedure mainly focused on the provisions applicable to nanomaterials, the cloning of animals for food production, traditional foods from third countries, the criteria to be examined for the risk assessment and risk management and to the procedure for the authorisation of novel foods in accordance with the Treaty on the Functioning of the European Union (Lisbon Treaty).
The discussions reached a stalemate on a limited number of issues (in particular those linked to cloning of animals). The Conciliation Committee did not reach a final agreement at its last meeting on 28 March 2011 and the proposal was not adopted by the Union legislator.
The Commission considers that issues related to cloning of farm animals should be addressed in a separate proposal, based on an impact assessment.
This proposal is therefore limited to the safety of novel food and is based on the overall agreement achieved in Conciliation.
· Current legislation
Authorisation and use of novel foods and food ingredients have been harmonised in the European Union since 1997 when Regulation (EC) No 258/97 on Novel Food and novel food ingredients was adopted. The current legislation consists of the Novel Food Regulation and one Commission Regulation:
– Regulation (EC) No 258/97 of the European Parliament and of the Council concerning novel foods and novel food ingredients lays down the general principles for authorisation of novel foods and food ingredients in the European Union.
– Commission Regulation (EC) No 1852/2001 lays down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97.
Currently, an application for a pre-market authorisation is first assessed by a Member State food assessment body. The initial assessment report is circulated for comments and objections to all Member States by the Commission. If no reasoned safety objections are presented, the novel food may be placed on the market. If reasoned safety objections are presented, an authorisation decision is required by the Commission. This in most cases includes an additional assessment which is carried out by the European Food Safety Authority (EFSA).
The authorisation under current rules is granted to the applicant (individual authorisation). In addition, another applicant may notify to the Commission the placing on the market of a food that is substantially equivalent to the authorised food. This notification has to be substantiated by scientific evidence showing the substantial equivalence of the notified food to the authorised food. These rules have allowed for placing on the market various foods such as Baobab dried fruit pulp, Chia seeds, fish (Sardinops sagax) peptide product or synthetic vitamin K2.
· Consistency with the other policies and objectives of the Union
The proposal brings together and updates the provisions of the above mentioned texts which will be repealed at the time of entry into application of the new legislation.
The proposal pursues the objectives of the Communication on Smart Regulation in the European Union and of the Europe 2020 Strategy. The emphasis is on simplifying and streamlining the regulatory process, thus reducing the administrative burden and improving the competitiveness of the European food industry, while ensuring the safety of food, maintaining a high level of public health protection and taking global aspects into consideration.
Contents
· Consultation of interested parties
Stakeholders from food industry, consumers, third countries and national authorities and international organisations have been consulted both before and after the adoption of Commission proposal of January 2008. Commission representatives also participated at several meetings or seminars organised by stakeholders and dedicated to specific issues (e.g. traditional food from third countries, assessment and authorisation procedure, nanotechnologies) and bilateral meetings with interested parties.
During the first and second reading and the Conciliation procedure on the 2008 legislative proposal, stakeholders also expressed their positions.
· Impact assessment
The Commission carried out an Impact Assessment in 2007. For each of the measures of the 2008 proposal, several options were examined with regard to their economic, social and environmental impact on the various stakeholders and Member States. It is available at ec.europa.eu/food/food/biotechnology/novelfood Regarding the current proposal, the 2008 impact assessment is still valid, as the rationale for an in-depth revision of the current legislation (the length and cost of the current authorisation procedure, the need for a centralised risk assessment and risk management and for an adjusted procedure for the placing on the EU market of traditional foods from third countries) is unchanged.
The main changes compared to the 2008 proposal are primarily those introduced during the Ordinary legislative procedure whose impact is unchanged as they only clarify the purpose of the measures.
As regards a possible exclusion of micro-enterprises from the scope, it appears that such an exemption would not be compatible with the overall objective of ensuring the safety of the novel foods which are put on the EU market.
· Legal basis
Legal basis of this proposal is Article 114 of the Treaty on the Functioning of the European Union.
· Subsidiarity principle
The proposal has to comply with the subsidiarity principle since it 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 reasons:
– Individual action by Member States could lead to different levels of food safety and protection of human health and confuse consumers. Repealing the Novel Food Regulation would do away with harmonised food safety rules and would endanger the free movement of food in the EU.
– Effective functioning of the internal market in relation to novel foods while protecting the health and the interest of the European consumers can best be met by action at EU level.
The proposal therefore complies with the subsidiarity principle.
· Proportionality principle
The proposal complies with the proportionality principle for the following reasons:
– The proposal harmonises the regulatory framework for novel food authorisation and thus contributes to the functioning of the food market in the EU.
– The proposed measures are sufficient in terms of reaching the objectives of ensuring food safety and securing the functioning of the internal market for food while reducing the administrative burden.
The financial and budgetary impact of the proposal is indicated in the legislative financial statement attached to this proposal.
The proposed instrument is Regulation.
Other means would not be adequate for the following reasons:
– The area of novel foods is fully harmonised in the EU. Non-legislative action based, for example, on a code of good practice or guidelines could not give sufficient protection and would lack legal certainty.
– The safe use of novel foods depends on pre-market safety evaluations and often on permitted conditions of use of these substances, therefore recommendations or self-regulations would not guarantee the protection of consumer's health.
· Simplification
The proposal provides for the simplification of legislation and administrative procedures for public authorities and private parties as compared to the legislation in place:
– There is only one centralised procedure for the assessment and authorisation of novel foods. The wording of the proposal has been up-dated and clarified.
– National administrative procedures and duplication of work are removed.
– The authorisation procedure is streamlined, increasing its efficiency and reducing the administrative burden in particular for private parties.
– A simplified procedure for the placing on the market of the traditional foods from third countries is introduced.
· Cost for business, in particular SMEs
The proposed measures will reduce administrative burden and the length and cost of the authorisation procedure for the food industry (18 months instead of 3 years in average currently). Generic authorisation will avoid the re-submission of new applications by other companies for the same novel food and are expected to benefit in particular SMEs. However, in order to maintain an incentive for developing really innovative food products, a 'data protection' regime with the granting of an applicant linked authorisation for a maximum of 5 years is introduced. The measures will also facilitate EU market access for traditional foods from third countries by setting up a simplified and more proportionate procedure.
· European Economic Area
The proposed act concerns an European Economic Area (EEA) matter and therefore extends to the EEA.
· Detailed explanation of the proposal
Chapter I – Subject matter, scope and definitions
Novel foods shall be subject to safety evaluation and authorisation via a fully harmonised procedure. The definitions are clarified and updated. It may be determined with the examination procedure if a food falls within the scope of the Regulation.
Nanomaterials which are intended for food uses and covered by the definition of 'engineered nanomaterials', as laid down in Regulation (EU) n°1169/2011 on Food Information to Consumers, shall be assessed and authorised under this Regulation before being placed on the EU market.
Chapter II – Requirements for placing novel foods on the market within the Union
All novel foods and their use in food have to comply with the following criteria: they should not present a danger to human health and their use should not mislead the consumer.
For every authorised novel food, specifications, labelling requirements, conditions of use and, where appropriate, a requirement of post-market monitoring may be laid down.
The current system of individual authorisations is replaced by generic authorisations. The so called current 'simplified procedure' based on substantial equivalence, which aims to extend an individual authorisation to another company for the same novel food, is removed since authorisations become directly generic.
Already authorised novel foods shall continue to be marketed and will be included in the Union list of novel foods.
Chapter III – Authorisation procedure for a novel food
In line with the decision to switch to a centralised EU-level procedure and to separate risk management and risk assessment, all applications for the authorisation of novel foods shall be submitted to the Commission. The Commission may then request a scientific opinion on risk assessment from the European Food Safety Authority (EFSA).
The inclusion of a novel food in the Union list of novel foods will be considered by the Commission on the basis of the opinion from EFSA. The Commission will be assisted by the Standing Committee on the Food Chain and Animal Health (SCOFCAH).
For traditional foods from third countries, a safety assessment and a risk management, based on a history of safe food use, is introduced. If a history of safe food use in a third country for at least 25 years has been demonstrated by the applicant, and if the Member States or EFSA do not present reasoned safety objections based on scientific evidence, the food may be included in the Union list.
However, in case reasoned safety objections are presented, an EFSA assessment followed by an EU authorisation procedure, similar to the standard authorisation procedure but with shorter deadlines, is required.
This procedure provides for a more proportionate risk assessment and risk management of traditional foods from third countries and allows for a quicker placing on the EU market for a range of products from primary production without compromising food safety.
Chapter IV – Additional procedural rules and other requirements
The information provided by the applicant should be kept confidential where the disclosure of such information might significantly harm their competitive position.
Chapter V – Data protection
By way of derogation from the generic authorisation in order to support innovation in the EU food industry and only in duly justified cases, individual authorisations with data protection may be granted for a maximum period of five years.
Chapter VI – Penalties and committee procedure
The Member States shall lay down rules on penalties applicable to infringements of the provisions of the proposed Regulation.
Implementation of the measures proposed in this Regulation will mainly be adopted by the Commission in accordance with the examination procedure laid down in Article 5 of Regulation (EU) n°182/2011. This consists of including the conditions of use and labelling of a novel food as well as laying down specifications and, where appropriate post-market monitoring requirements.
Chapter VII – Transitional and final provisions
Transitional measures are necessary to ensure a smooth transition with on-going applications and notifications, pending the entry into application of this legislation. Furthermore, due to clarification of the definition of the novel food laid down in this Regulation and to enhance legal certainty, a food that was legally placed on the market prior to the application of this Regulation, should be allowed to be continued to be marketed until the risk assessment and authorisation procedures have been concluded.