EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
SANCO/12373/2011 Rev. 3 (POOL/E4/2011/12373/12373R3-EN) 
[…](2011) XXX draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX 
establishing implementing rules for the application of Article 8 of Regulation (EC) 
No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on 
the addition of vitamins and minerals and of certain other substances to foods 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX 
establishing implementing rules for the app lication of Article 8 of Regulation (EC) 
No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on 
the addition of vitamins and minerals and of certain other substances to foods 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1925/2006 of the European Parliament and of the 
Council of 20 December 2006 on the addition of v itamins and minerals and of certain other 
substances to foods
1, and in particular Article 8 (6) thereof, 
Whereas: (1) Requests by Member States or on the ini tiative of the Commission, to initiate the 
procedure under Article 8 (2) of Regulation (EC) No 1925/2006 to prohibit, restrict or 
place under Union scrutiny a substance othe r than vitamins or minerals, or an 
ingredient containing a substa nce other than vitamins or minerals that is added to 
foods or used in the manufacture of foods should meet certain conditions and uniform 
rules should be established for checking th at these conditions are met. One of the 
conditions laid down in Article 8 (1) of  Regulation (EC) No 1925/2006 is that the 
intake of the substance should greatly exceed normal intake  of a balanced and varied 
diet and it should present a potential risk to consumers as demonstrated by relevant 
scientific data. Further, Article 8 (1) of Regulation (EC) No 1925/2006 provides that 
the procedure should also be applied where th e substance presents a potential risk to 
health for reasons other than a great excess of its normal intake . In addition, 
Article 8 (1) of Regulation (EC) No 1925/ 2006 provides that the substance should be 
added to foods or used in the manufacture of foods. 
(2) For the purpose of the application of the condition mentioned above , dietary intakes of 
the concerned substance that greatly exceed those expected  under normal conditions of 
consumption of a balanced and varied diet s hould reflect actual in take of the substance 
and not a theoretical assumption of intake , and should be assessed on a case by case 
basis in comparison with the average level of intake of the substance by the general adult population or other population groups for which potential risks to consumers 
have been identified.  
(3) The Member State putting forward a request should provide the necessary information 
to demonstrate that the conditions require d by Regulation (EC) No 1925/2006 are met. 
This should include information on th e placing on the market of food products 
                                                
 
1 OJ L 404, 30.12.2006, p. 26.   
EN 3   EN containing the substance and the available an d relevant generally accepted scientific 
evidence that associates the substance with a potential risk to consumers. Only those 
requests ascertained as complete should be sent to the European Food Safety Authority 
(hereafter "the Authority") for a safety assessment based on the available information. The Authority should adopt an opinion on the safety of the substance within a specified time limit as laid down in Artic le 29 (3) of Regulation (EC) No 178/2002
2. 
Interested parties should be allowed to submit comments to the Commission following the publication of the opinion by the Authority. 
(4) Article 8 (4) of Regulation (EC) No 1925/2006 states that food business operators, or 
any other interested parties, may at any time submit for evaluation to the Authority a 
file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C of that Regulation, under the conditions of its use in a food or in a category of foods and explaining the purpose of  that use. Any such file submitted by a 
food business operator or interested part y should be based on guidance documents 
adopted or endorsed by the Authority, such as the guidance on submissions for safety 
evaluation of sources of nutri ents or of other ingredients proposed for use in the 
manufacture of food, or a ny further revised version of such guidance.  
(5) In order for the Commission to take a deci sion concerning a s ubstance included in 
Annex III, Part C of Regulation (EC) No 1925/2006 within the required deadline, it is 
necessary to take into consideration only those files submitted within 18 months from 
the date a substance has been included in that Annex. Furthermore, in order for the 
Commission to take a decision within the stipulated deadline, the Authority should 
give its opinion on the safety of the substance within a tim e limit of 9 months from 
receiving a file that is c onsidered to be valid and complete in accordance with the 
guidance documents adopted or endorsed by the Authority. 
(6) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Subject matter 
This Regulation establishes implementing rules fo r the application of Article 8 of Regulation 
(EC) No 1925/2006 and in particular: 
(a) the conditions for the us e of the procedure referred to  in paragraphs 1 and 2 of 
Article 8 of Regulation (EC) No 1925/2006; and  
(b) the procedure referred to in paragraphs  4 and 5 of Article 8 of Regulation (EC) 
No 1925/2006 concerning substances listed in Annex III, Part C thereof.  
                                                
 
2 OJ L 31, 1.2.2002, p. 1.  
EN 4   EN Article 2 
Definitions 
For the purpose of this Regulation the following definitions shall apply: 
(a) "Request" means the submission to the Commission by a Member State of 
information, including scientific data, fo r the purpose of initiating the procedure 
under paragraph 2 of Article 8 of Regulation (EC) No 1925/2006. 
(b) "File" means a file as referred to in pa ragraphs 4 and 5 of Article 8 of Regulation 
(EC) No 1925/2006 that is submitted by a food business operator or interested party 
to the Authority.  
(c) "Placing on the market" as defined by Article 3 (8) of Regulation (EC) 
No 178/20023. 
Article 3 
Conditions to be met for the request 
1. In the assessment of the conditions under which the concerned substance is added to 
foods or used in the manufacture of foods, as  laid down in paragra ph 1 of Article 8 of 
Regulation (EC) No 1925/2006, the placing on the market in one or more Member 
States of the food product to which the subs tance has been added shall be taken into 
account.  
2. Member States may submit a request to the Commission when the assessment 
referred to in paragraph 1 shows at least one of the following: 
(a) a potential risk to consum ers is associated with the ingestion of amounts of the 
substance that greatly exceed those reasonably expected under normal conditions of 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; 
(b) a potential risk to consumers is a ssociated with the consumption of this 
substance by the general adult populati on or other specified population group 
for which a potential risk has been identified. 
3. For the purposes of this Regulation those c onditions that would result in the ingestion 
of amounts of a substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumpti on of a balanced and varied diet shall 
occur under actual circumstan ces and shall be assessed on a case by case basis in 
comparison with the average intake of th e concerned substance by the general adult 
population or other specified population group for which heal th concerns have been 
raised. 
4. The conditions and requirements laid down in paragraphs 1, 2 and 3 of this Article 
and the requirements laid down in Artic le 4 of this Regulation, shall apply mutatis 
                                                
 
3 OJ L 31, 1.2.2002, p. 1.  
EN 5   EN mutandis  where the procedure under Article 8 of Regulation (EC) No 1925/2006 is 
initiated by the Commission. 
Article 4 
Content of the request 
1. The request shall contain the available a nd relevant generally accepted scientific 
evidence demonstrating that the conditions specified in Article 8 (1) of Regulation 
(EC) No 1925/2006 are met and shall include:  
(a) Evidence demonstrating the addition of  the substance to food or use of the 
substance in the manufacture of food.  
Such evidence shall include informati on on the current placing on the market 
of food products containing the substan ce as referred to in paragraph 1 of 
Article 3 of this Regulation.  
(b) In cases referred to in Article 3 (2) (a), evidence demonstrating that intake of 
the substance greatly exceeds normal conditions of consumption of a balanced and varied diet, as assessed in accordance with Article 3 (3).  
Such evidence shall include scientific data that represents actual dietary intake 
of the substance obtained from the most recently available dietary intake 
surveys or food 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. Member States  shall provide justification for the 
basis of their assessment of "normal c onditions of consumption of a balanced 
and varied diet" when making the request.  
(c) Evidence demonstrating a potential risk  to consumers from consumption of the 
substance.  
This evidence shall consist of relevant  scientific data including unpublished 
validated reports, scientif ic opinions by a public  risk assessment body or 
independent and peer-reviewed articles. A summary of the scientific data and the list of references of the sc ientific data sh all be provided.  
2. The Commission may ask the Member State to  provide clarifica tions or additional 
information if the request is incomplete.  
3. The Commission shall publis h any complete request made  by a Member State on its 
official website. 
4. The Commission shall send the request to  the Authority accompanied by all the 
available information, following consultati on of the Member States. The Authority 
shall adopt a scientific opinion within a specified time limit as laid down by Article 29 (3) of Regulation (EC) No 178/2002.  
5. Interested parties may submit comments to  the Commission within 30 days from the 
publication by the Authority of its opinion.  
EN 6   EN Article 5 
Substance included in Annex III, Part C 
1. To be considered valid, a file submitted by a food business operator or any other 
interested party to the Authority in view of a safety assessment of the substance 
placed in Part C of Annex III of Regulation (EC) 1925/2006, pursuant to the 
procedure provided under Article 8 (4) of Regulation (EC) No 1925/2006, shall be 
based on relevant guidance documents a dopted or endorsed by the Authority.  
In the case where it cons iders a file as not valid for the purpose 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 considered valid. 
2. Only files submitted within eighteen months from the entry into force of a decision 
that includes a substance to Part C of  Annex III of Regulation (EC) No 1925/2006 
pursuant to Article 8 (2) of Regulati on (EC) No 1925/2006 shall be taken into 
account by the Authority as being a valid file  for the purposes of a decision as laid 
down in paragraph 5 of Article  8 of Regulation (EC) 1925/2006. 
Article 6 
Opinion of the Authority 
1. The Authority shall give its opinion on f iles referred to in Article 5 (1) of this 
Regulation within 9 months from the date of receipt of a valid file. The Authority 
shall assess the validity of the file with in 30 days from receipt of the file. 
2. The Authority may request the food busin ess operator or interested party to 
supplement the data or information submitted in a file within a specified time limit. 
When the Authority seeks supplementary information from the food business operator or any other interest ed party, the time limit referred to in paragraph 1 shall 
be extended only once by up to three months and shall in clude the time needed by 
the food business operator or any interest ed party to provide this supplementary 
information. The food business operator or interested party shall submit the 
requested information within 15 days from the date of receipt of the Authority's 
request. 
Article 7 
This Regulation shall enter into force on the [… ] day following that of its publication in the 
Official Journal of the European Union .  
EN 7   EN This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 José Manuel BARROSO  The President