HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 102/2
EN
Official Journal of the European Union
12.4.2012
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 307/2012
of 11 April 2012
establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of
the European Parliament and of the Council on the addition of vitamins and minerals and of certain
other substances to foods
THE EUROPEAN COMMISSION,
adult population or other population groups for which
potential risks to consumers have been identified.
Having regard to the Treaty on the Functioning of the European
Union,
(3) The
Member
State
putting
forward
a
request
should
provide the necessary information to demonstrate that
the conditions required by Regulation (EC) No
1925/2006 are met. This should include information
Having regard to Regulation (EC) No 1925/2006 of the
on the placing on the market of food products
European Parliament and of the Council of 20 December
containing the substance and the available and relevant
2006 on the addition of vitamins and minerals and of certain
generally accepted scientific evidence that associates the
other substances to foods ( 1 ), and in particular Article 8(6)
substance with a potential risk to consumers. Only those
thereof,
requests ascertained as complete should be sent to the
European Food Safety Authority (hereafter ‘the Auth
ority’) for a safety assessment based on the available
Whereas:
information. The Authority should adopt an opinion
on the safety of the substance within a specified time
limit as laid down in Article 29(3) of Regulation (EC)
No 178/2002 of the European Parliament and of the
(1) Requests
by
Member
States
or
on
the
initiative
of
the
Council ( 2 ). Interested parties should be allowed to
Commission, to initiate the procedure under Article 8(2)
submit comments to the Commission following the
of Regulation (EC) No 1925/2006 to prohibit, restrict or
publication of the opinion by the Authority.
place under Union scrutiny a substance other than
vitamins or minerals, or an ingredient containing a
substance other than vitamins or minerals that is added
to foods or used in the manufacture of foods should
(4) Article
8(4)
of
Regulation
(EC)
No
1925/2006
states
that
meet certain conditions and uniform rules should be
food business operators, or any other interested parties,
established for checking that these conditions are met.
may at any time submit for evaluation to the Authority a
One of the conditions laid down in Article 8(1) of Regu
file containing the scientific data demonstrating the safety
lation (EC) No 1925/2006 is that the intake of the
of a substance listed in Annex III, Part C to that Regu
substance should greatly exceed normal intake of a
lation, under the conditions of its use in a food or in a
balanced and varied diet and it should present a
category of foods and explaining the purpose of that use.
potential risk to consumers as demonstrated by
Any such file submitted by a food business operator or
relevant scientific data. Further, Article 8(1) of Regulation
interested party should be based on guidance documents
(EC) No 1925/2006 provides that the procedure should
adopted or endorsed by the Authority, such as the
also be applied where the substance presents a potential
guidance on submissions for safety evaluation of
risk to health for reasons other than a great excess of its
sources of nutrients or of other ingredients proposed
normal intake. In addition, Article 8(1) of Regulation
for use in the manufacture of food, or any further
(EC) No 1925/2006 provides that the substance should
revised version of such guidance.
be added to foods or used in the manufacture of foods.
(5) In order for the Commission to take a decision
(2)
For the purpose of the application of the condition
concerning a substance included in Annex III, Part C to
mentioned above, dietary intakes of the concerned
Regulation (EC) No 1925/2006 within the required
substance that greatly exceed those expected under
deadline, it is necessary to take into consideration only
normal conditions of consumption of a balanced and
those files submitted within 18 months from the date a
varied diet should reflect actual intake of the substance
substance has been included in that Annex. Furthermore,
and not a theoretical assumption of intake, and should
in order for the Commission to take a decision within
be assessed on a case-by-case basis in comparison with
the stipulated deadline, the Authority should give its
the average level of intake of the substance by the general
opinion on the safety of the substance within a time
( 1 ) OJ L 404, 30.12.2006, p. 26.
( 2 ) OJ L 31, 1.2.2002, p. 1.

---

EN
12.4.2012 Official
Journal
of
the
European
Union L
102/3
limit of nine months from receiving a file that is
(a) a potential risk to consumers is associated with the
considered to be valid and complete in accordance
ingestion of amounts of the substance that greatly exceed
with the guidance documents adopted or endorsed by
those reasonably expected under normal conditions of
the Authority.
consumption of a balanced and varied diet, due to the
conditions under which the substance is added to food or
used in the manufacture of food;
(6) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(b) a potential risk to consumers is associated with the
consumption of this substance by the general adult popu
HAS ADOPTED THIS REGULATION:
lation or other specified population group for which a
potential risk has been identified.
Article 1
3. For
the
purposes
of
this
Regulation
those
conditions
that
Subject matter
would result in the ingestion of amounts of a substance greatly
This Regulation establishes implementing rules for the appli
exceeding those reasonably expected to be ingested under
cation of Article 8 of Regulation (EC) No 1925/2006 and in
normal conditions of consumption of a balanced and varied
particular:
diet shall occur under actual circumstances and shall be
assessed on a case-by-case basis in comparison with the
average intake of the concerned substance by the general
(a) the conditions for the use of the procedure referred to in
adult population or other specified population group for
paragraphs 1 and 2 of Article 8 of Regulation (EC) No
which health concerns have been raised.
1925/2006; and
4. The
conditions
and
requirements
laid
down
in
paragraphs
(b) the procedure referred to in paragraphs 4 and 5 of Article 8
1, 2 and 3 of this Article and the requirements laid down in
of Regulation (EC) No 1925/2006 concerning substances
Article 4 of this Regulation, shall apply mutatis mutandis where
listed in Annex III, Part C thereto.
the procedure under Article 8 of Regulation (EC) No
1925/2006 is initiated by the Commission.
Article 2
Definitions
Article 4
For the purpose of this Regulation the following definitions
Content of the request
shall apply:
1. The
request
shall
contain
the
available
and
relevant
generally accepted scientific evidence demonstrating that the
(a) ‘request’ means the submission to the Commission by a
conditions specified in Article 8(1) of Regulation (EC) No
Member State of information, including scientific data, for
1925/2006 are met and shall include:
the purpose of initiating the procedure under paragraph 2
of Article 8 of Regulation (EC) No 1925/2006;
(a) Evidence demonstrating the addition of the substance to
food or use of the substance in the manufacture of food.
(b) ‘file’ means a file as referred to in paragraphs 4 and 5 of
Article 8 of Regulation (EC) No 1925/2006 that is
submitted by a food business operator or interested party
Such evidence shall include information on the current
to the Authority;
placing on the market of food products containing the
substance as referred to in paragraph 1 of Article 3 of
(c) ‘placing on the market’ as defined by Article 3(8) of Regu
this Regulation.
lation (EC) No 178/2002.
(b) In cases referred to in Article 3(2)(a), evidence demon
Article 3
strating that intake of the substance greatly exceeds
normal conditions of consumption of a balanced and
Conditions to be met for the request
varied diet, as assessed in accordance with Article 3(3).
1. In the assessment of the conditions under which the
concerned substance is added to foods or used in the manu
facture of foods, as laid down in paragraph 1 of Article 8 of
Such evidence shall include scientific data that represents
Regulation (EC) No 1925/2006, the placing on the market in
actual dietary intake of the substance obtained from the
one or more Member States of the food product to which the
most recently available dietary intake surveys or food
substance has been added shall be taken into account.
consumption surveys. The inclusion of foods to which the
substance has been added and/or food supplements
containing the substance may be taken into account.
2. Member States may submit a request to the Commission
Member States shall provide justification for the basis of
when the assessment referred to in paragraph 1 shows at least
their assessment of ‘normal conditions of consumption of
one of the following:
a balanced and varied diet’ when making the request.

---

L 102/4
EN
Official Journal of the European Union
12.4.2012
(c) Evidence demonstrating a potential risk to consumers from
In the case where it considers a file as not valid for the purpose
consumption of the substance.
of the first subparagraph, the Authority shall inform the food
business operator or interested party that has submitted the file
and the Commission, indicating the reasons why the file is not
This evidence shall consist of relevant scientific data
considered valid.
including unpublished validated reports, scientific opinions
by a public risk assessment body or independent and peer-
reviewed articles. A summary of the scientific data and the
2. Only
files
submitted
within
18
months
from
the
entry
list of references of the scientific data shall be provided.
into force of a decision that includes a substance to Part C of
Annex III to Regulation (EC) No 1925/2006 pursuant to
Article 8(2) of Regulation (EC) No 1925/2006 shall be taken
2. The
Commission
may
ask
the
Member
State
to
provide into account by the Authority as being a valid file for the
clarifications or additional information if the request is incom
purposes of a decision as laid down in paragraph 5 of
plete.
Article 8 of Regulation (EC) No 1925/2006.
3. The Commission shall publish any complete request made
Article 6
by a Member State on its official website.
Opinion of the Authority
1. The Authority shall give its opinion on files referred to in
4. The Commission shall send the request to the Authority
Article 5(1) of this Regulation within nine months from the
accompanied by all the available information, following consul
date of receipt of a valid file. The Authority shall assess the
tation of the Member States. The Authority shall adopt a
validity of the file within 30 days from receipt of the file.
scientific opinion within a specified time limit as laid down
by Article 29(3) of Regulation (EC) No 178/2002.
2. The
Authority
may
request
the
food
business
operator
or
interested party to supplement the data or information
5. Interested parties may submit comments to the submitted in a file within a specified time limit. When the
Commission within 30 days from the publication by the
Authority seeks supplementary information from the food
Authority of its opinion.
business operator or any other interested party, the time limit
referred to in paragraph 1 shall be extended only once by up to
three months and shall include the time needed by the food
Article 5
business operator or any interested party to provide this supple
Substance included in Annex III, Part C
mentary information. The food business operator or interested
party shall submit the requested information within 15 days
1.
To be considered valid, a file submitted by a food business
from the date of receipt of the Authority’s request.
operator or any other interested party to the Authority in view
of a safety assessment of the substance placed in Part C of
Article 7
Annex III to Regulation (EC) No 1925/2006, pursuant to the
procedure provided under Article 8(4) of Regulation (EC) No
This Regulation shall enter into force on the twentieth day
1925/2006, shall be based on relevant guidance documents
following that of its publication in the Official Journal of the
adopted or endorsed by the Authority.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 11 April 2012.
For the Commission
The President
José Manuel BARROSO

---

Document Outline

• �

---