Date: 2019-04-25Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Regulation (EU) 2019/649 of 24 April 2019 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 fat of animal origin (Text with EEA relevance.)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Regulation (EU) 2019/649 amends Regulation (EC) No 1925/2006, setting a maximum limit for trans fat (other than that naturally occurring in animal fat) in food. The regulation mandates that food businesses provide information on trans fat content to other businesses in the supply chain. It took effect on May 15, 2019, with a grace period allowing non-compliant food to be placed on the market until April 1, 2021.
Key Points / Main Content:
* **Trans Fat Limit:** The content of trans fat, other than trans fat naturally occurring in fat of animal origin, in food intended for the final consumer and food intended for supply to retail, shall not exceed 2 grams per 100 grams of fat.
* **Information Requirement:** Food business operators supplying other food business operators with food not intended for the final consumer or retail must provide information on the amount of trans fat (excluding naturally occurring animal fat) if it exceeds 2 grams per 100 grams of fat.
* **Definitions:** The definitions of "fat" and "trans fat" from Regulation (EC) No 1169/2011 and the definition of "retail" from Regulation (EC) No 178/2002 apply.
* **Amendment to Annex III:** Part B of Annex III to Regulation (EC) No 1925/2006 is amended as specified in the Annex of this regulation.
* **Entry into Force and Transitional Measures:** The Regulation entered into force on May 15, 2019. Food not compliant with the regulation could continue to be placed on the market until April 1, 2021.
Impact Analysis:
Final Consumers:
* Impact: Consumers will have access to food products with lower levels of industrially produced trans fats, potentially reducing the risk of heart disease.
* Action Required: No specific action required.
Retailers:
* Impact: Retailers must ensure that the food they supply to consumers complies with the new trans fat limit.
* Action Required: Ensure compliance with the 2g/100g limit by April 1, 2021.
Food Manufacturers (Supplying Retailers):
* Impact: Manufacturers must reformulate products if necessary to meet the new trans fat limit.
* Action Required: Reformulate products to meet the 2g/100g limit and ensure compliance by April 1, 2021.
Food Business Operators (Supplying Other Businesses):
* Impact: These operators must provide information to their customers (other food businesses) regarding the trans fat content in their products.
* Action Required: Provide accurate information on trans fat content (if exceeding 2g/100g) to other food business operators they supply.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EC No 1925/2006: Regulation of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods.
European Parliament: The directly elected parliamentary assembly of the European Union.
Council of the European Union: A legislative body of the European Union comprising ministers from member states.
European Food Safety Authority: The European Union agency that provides independent scientific advice and communicates on existing and emerging risks associated with the food chain.
World Health Organisation: A specialized agency of the United Nations responsible for international public health.
Brussels: The de facto capital city of the European Union, located in Belgium, where the regulation was adopted.
25.4.2019 EN Official Journal of the European Union L 110/17
COMMISSION REGULATION (EU) 2019/649
of 24 April 2019
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 fat of animal origin
(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 foods (1), and in particular Article 8(2)
thereof,
Whereas:
(1) In accordance with Regulation (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 is 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’) adopted a scientific
opinion (2) 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 population (3). 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 appears 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.
(6) On 19 June 2018, the Authority provided its conclusion in the form of scientific and technical assistance. It
concluded (4) based on review of available scientific evidence that according to the latest national and internat
ional 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 supply (5).
(8) Trans fat is a substance other than vitamins and minerals for which harmful effects 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.
(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.
(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.L 110/18 EN Official Journal of the European Union 25.4.2019
(9) The definitions of ‘fat’ and of ‘trans fat’ set out in Annex I of Regulation (EC) No 1169/2011 of the European
Parliament and of the Council (6) and of ‘retail’ set out in Article 3(7) of Regulation (EC) No 178/2002 of the
European Parliament and of the Council (7) should apply to the relevant terms in Part B of Annex III to
Regulation (EC) No 1925/2006.
(10) In order to facilitate the application of this Regulation, it is necessary to require from food business operators
supplying food to other food business operators with the exception of retailers, to provide them with the
information on the amount of trans fat, other than trans fat naturally occurring in fat of animal origin, where
that amount exceeds 2 grams per 100 grams of fat.
(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 adopted.
(12) Regulation (EC) No 1925/2006 should therefore be amended accordingly.
(13) 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
The content of trans fat, other than trans fat naturally occurring in fat of animal origin, in food intended for the final
consumer and food intended for supply to retail, shall not exceed 2 grams per 100 grams of fat.
Article 2
Food business operators supplying other food business operators with food not intended for the final consumer or not
intended for supply to retail, shall ensure that supplied food business operators are provided with information on the
amount of trans fat, other than trans fat naturally occurring in fat of animal origin, where that amount exceeds 2 grams
per 100 grams of fat.
Article 3
Part B of Annex III to Regulation (EC) No 1925/2006 is amended in accordance with the Annex to this Regulation.
Article 4
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.
(6) Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food
information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the
Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC,
Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and
Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).
(7) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).25.4.2019 EN Official Journal of the European Union L 110/19
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 April 2019.
For the Commission
The President
Jean-Claude JUNCKERL 110/20 EN Official Journal of the European Union 25.4.2019
ANNEX
In Part B of Annex III to Regulation (EC) No 1925/2006 the following table is inserted:
‘PART B
Restricted substances
Restricted substance Conditions of use Additional requirements
Trans fat other than trans Maximum 2 grams per 100 grams of Food business operators supplying other food
fat naturally occurring in fat fat in food intended for the final con business operators with food not intended for
of animal origin sumer and food intended for supply the final consumer or not intended for supply to
to retail retail, shall ensure that supplied food business
operators are provided with information on the
amount of trans fat, other than trans fat nat
urally occurring in fat of animal origin, where
that amount exceeds 2 grams per 100 grams of
fat.’