EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10819/2018 
(POOL/E1/2018/10819/10819 -EN.doc)  
[…](2018) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and 
of the Council as regards trans fat, other than trans fat naturally occurring in animal 
fat, in foods intended for the final consumer  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and 
of the Council as regards  trans fat, other than trans fat naturally occurring in animal 
fat, in foods intended for the final consumer  
(Text with EEA relevance)  
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 vitamins and minerals and of certain other 
substances to foods1, and in particular Article 8(2) thereof,  
Whereas:  
(1) In accordance with Regulatio n (EC) No 1925/2006, the Commission may , on its own 
initiative,  take a decision to include a substance , other than a vitamin or mineral , or an 
ingredient containing such substance in Annex III to that Regulation, listing the 
substances whose use in foods i s prohibited, restricted or under Union scrutiny, if that 
substance is associated with a potential risk to consumers as provided for in Article 
8(1) of that Regulation.   
(2) On 4 December 2009 , the European Food Safety Authority (hereinafter 'the 
Authority') a dopted a scientific opinion2 concluding  that the intake of trans fatty acids 
should be as low as possible within the context of a nutritionally adequate diet.  
(3) On 3 December 2015, the Commission adopted a report on trans fats in foods and in 
the overall diet of the Union population3. The report recalled that coronary heart 
disease is the leading cause of death in the Union and a high intake of trans fats 
seriously increases the risk of heart disease, more than any other nutrient on a per 
calorie basis.  
(4) The report concluded that establishing a legal limit for industrial trans fats in food 
appear s to be the most effective measure in terms of public health, consumer 
protection and compatibility with the internal market.  
(5) On 30 April 2018, the Commission asked  the Authority to compile the outcomes of 
scientific advice already provided by the Authority on the health effects of trans fats, in 
particular on nutrition and health claims, dietary reference values and food additives; and 
to inform the Commission on how such scientific advice relates to current goals and 
recommendations on the intake of trans fats to maintain health.  
                                                 
1 OJ L 404, 30.12.2006 , p. 26.  
2 EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA); Scientific Opinion on Dietary 
Reference Values for fats, including saturated fatty acids, polyunsaturated fatty acids, monounsaturated 
fatty acids, trans fatty acids, and cholesterol. EFSA Journal 2010; 8(3):1461.  
3 COM(2015)619 final of 3.12.2015.   
EN 2  EN (6) On 19 June 2018, the Authority provided its conclusion in the form of scientific and 
technical assistance. It concluded4 based on r eview of available scientific evidence  that 
according to the latest national and international recommendations,  dietary intakes of 
trans fatty acids should be as low as possible . 
(7) On 15 May 2018, the World Health Organisation called for the elimination of 
industrially -produced trans fatty acids from global food supply5.  
(8) Trans fat is a substance other than vitamins and minerals for which harmful effect s on 
health have been identified . The substance should therefore be placed in Part B of 
Annex III to Regulation (EC) No 1925/2006  and its addition to foods or its use in the 
manufacture of foods should only be allowed under the conditions specified in that 
Annex, in view of the current state of scientific and technical knowledge . 
(9) Regulation ( EC) No 1925/2006 should therefore be amended accordingly.  
(10) The definitions of "fat" and of "trans fat " set out in Annex I to Regulation (EC) 
No 1169/2011 of 25 October 2011 of the European Parliament and of the  Council6 
should apply to the relevant terms in Part B of Annex III to Regulation (EC) 
No 1925/2006 .  
(11) In order to enable food business operators to adapt to the new requirements which will 
result from this Regulation , appropriate transitional measures should be ado pted. 
(12) The measures provided for in this Regulation are in accordance with the opinion of 
the Standing Committee  on Plants, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
In Part B of Annex III to Regulation (EC) No 1925/2006, the following entry is added:  
'Trans fat  
The following conditions shall apply:  
a. The content of trans fat, other than trans fat naturally occurring in animal fat, in food 
which is intended for the final consumer, shall not exceed 2 grams per 100 grams of 
fat. 
b. The de finitions of "fat" and of "'trans fat " set out respectively in points (2) and (4) of 
Annex I to Regulation (EC) No 1169/2011 shall  apply . 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Food which does not comply with this Regulation may continue to be placed on the market 
until 1 April 2021 . 
                                                 
4 EFSA, 2018 . Scientific and technical assistance on trans fatty  acids. EFSA supporting publication 
2018:EN -1433. 16 pp. doi:10.2903/sp.efsa.2018.EN -1433.  
5 REPLACE – an Action package to eliminate industrially -produced trans fatty acids, reference 
WHO/NMH/NHD/18.4, May 2018.  
6 OJ L 304, 22.11.2011, p.  18.  
EN 3  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Bruss els, 
 For the Commission  
 The President  
 Jean -Claude JUNCKER