6 EU regulation on novel foods
| (35695)
18171/13
COM(13) 894
| Draft Regulation on novel foods
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| Legal base
| Article 114 TFEU; co-decision; QMV
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| Document originated
| 18 December 2013
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| Deposited in Parliament
| 31 December 2013
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| Department
| Food Standards Agency
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| Basis of consideration
| EM of 15 January 2014
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| Previous Committee Report
| None (but see para 6.2 below)
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| Discussion in Council
| See para 6.6 below
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| Committee's assessment
| Politically important
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| Committee's decision
| Not cleared; further information requested
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Background
6.1 For the purposes of EU legislation,
"novel foods" are defined as all foods or food ingredients
which have not been consumed in the Union to a significant degree
before 15 May 1997, and they are currently subject to the provisions
of Regulation (EC) No. 258/97 (which, among other things, requires
a mandatory pre-market authorisation before such a food can be
placed on the market).
6.2 In 2008, the Commission put forward
a proposal to replace and repeal Regulation (EC) No. 258/97, and
to streamline the authorisation procedure, but the subsequent
negotiations broke down in 2011 without agreement between the
Council and the European Parliament, notably over the inclusion
of provisions on cloned animals. However, the controls over the
cloning of farmed animals and the regulation of food from such
animals has recently been the subject of separate proposals,[31]
which we reported to the House on 22 January 2014, and the Commission
has now put forward this new proposal for an amended Novel Foods
Regulation which excludes any reference to cloned animals.
The current proposal
6.3 Apart from that exclusion, the proposal
is broadly similar to the 2008 text, its main purpose being to
introduce a centralised authorisation procedure in place of the
current system, which requires an initial assessment to be carried
out by a single Member State, which is then sent to all other
Member States for comment — a process which takes a significant
period of time, particularly as most dossiers are later referred
to European Food Safety Authority (EFSA) for safety assessment
on any concerns raised. The proposed centralised process, which
is intended to be more efficient and to result in a streamlined
procedure, would require applications to be submitted to the Commission,
with any opinion it requests from the EFSA being submitted to
the Member States and the applicant as well: and, within nine-months
of receiving that opinion, the Commission must submit to a draft
implementing act to the Standing Committee on the Food Chain and
Animal Health (where it would be subject to the procedures laid
down in Regulation (EU) No. 182/2011).
6.4 The proposal would also introduce
the following additional changes:
Simplified safety assessment of traditional food
from third countries
At present, foods widely consumed elsewhere
in the world have to undergo the same lengthy procedures as completely
innovative products. The proposal will enable traditional foods,
from primary production, to gain an authorisation relatively quickly
if applicants are able to demonstrate a history of safe use outside
the EU for at least 25 years.
Application to relevant new food technologies
The current provisions have, on occasions,
been found to be ambiguous in their application to new technologies,
such as nanotechnology, and the proposal will ensure that those
not previously used in the food chain will require a pre-market
safety evaluation.
Relation to legislation on specific food categories
Developments in EU legislation since
1997 have resulted in parallel authorisation procedures being
established for ingredients in certain categories of food such
as food supplements and medical foods. As a result, a new ingredient
can require multiple authorisations before it can be placed on
the market, and the proposal aims to minimise such overlaps.
Data Protection
Under the new proposal, applicants who
have invested in new data to demonstrate the suitability of their
product can seek a limited (five-year) period of data protection,
whereby, if authorisation is granted, the applicant would be given
the sole right to market the product during this period, thus
providing an incentive for companies to invest in the development
of new ingredients. Other operators could apply for authorisation
during the five-year period, but they would have to provide their
own safety data.
The Government's view
6.5 In her Explanatory Memorandum of
15 January 2014, the Parliamentary Under Secretary of State for
Public Health (Jane Ellison) says that the proposal is welcome
as it updates the existing novel foods regulation, in order to
align it with other food legislation and to clarify its scope.
In particular, so long as the new authorisation procedure maintains
the level of consumer protection provided by the current procedure
and is equally transparent, she welcomes its increased efficiency
in reducing the costs to applicants and the time needed to obtain
an authorisation.
6.6 The Minister says that the proposal
will be subject to separate consultations in England, Scotland,
Wales and Northern Ireland, which are likely to begin early in
February 2014, with an analysis of responses received being submitted
in due course, and that, in the meantime, discussions at Council
Working Group level are expected to begin in the next few weeks
under the Greek Presidency. She also notes that the Commission
has suggested that the European Economic and Social Committee
should be consulted; that progress is likely to be linked to the
two parallel proposals on animal cloning and on food from cloned
animals; and that, given the impending European Parliament elections
and the appointment of a new Commission, only limited progress
is expected before September 2014.
Conclusion
6.7 The previous proposal in 2008
to amend the Novel Foods Regulation gave rise to a number of contentious
issues relating to animal cloning. Whilst the current proposal
appears more straightforward, we note that it is to be subject
to separate consultations in England, Scotland, Wales and Northern
Ireland, and that discussions at Council Working Group level are
expected to begin shortly. We ask the Government to keep us informed
of the outcome of those consultations and discussions, and in
particular whether any suggestion emerges that the draft Regulation
could result in a degree of competence creep. In the meantime,
we are holding the document under scrutiny.
31 see (35688) 18152/13 and (35689) 18153/13: HC 83-xxviii
(2013-14), chapter 3 (22 January 2014). Back
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