Hard times for industrial trans fats: EU upcoming legal limit and FDA moves

The EU Commission recently launched a public consultation on a draft Regulation setting a legal limit for trans fat, other than trans fat naturally occurring in animal fat, in foods intended for the final consumer.

The consultation will be open until 1st November 2018 and anybody can participate.

The draft Regulation is pretty straightforward and it is made of just 2 articles.

Basically it states that, after EFSA opinion suggesting to limit as much as possible the intake of industrial trans fat – and the following assessment of the EU Commission about the viable options to reach this goal – setting a limit was the only realistic option to protect public health.

Therefore art. 1 states that in Part B of Annex III to Regulation (EC) No 1925/2006 (on fortification of food and substances that might add to food and supplements), 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 definitions 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.”

Therefore, the limit would not be applicable to B2B foods, provided that they are used in a way that grants no more that 2 g T-fat/100 g fat on the final products.

A transitional period is given by art. 2: food which does not comply with this draft Regulation may continue to be placed on the market until 1 April 2021.

In the meantime I remember to all our readers that in 2015, US FDA determined that PHOs (partially hydrogenated oils), the major source of artificial trans fat in the food supply, are no longer “Generally Recognized as Safe” (GRAS). For the majority of uses of PHOs, June 18, 2018, remains the date after which manufacturers cannot add PHOs to foods, without filing a specific GRAS petition affirming the safety of use. However, to allow for an orderly transition in the marketplace, FDA is allowing more time for products produced prior to June 18, 2018 to work their way through distribution. FDA is extending the compliance date for these foods to January 1, 2020.

You can find the FDA related resources here.

FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule (Food defense)

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards.

The FDA announced today the availability of an SECG to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.

The SECG was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. It provides nonbinding recommendations on such topics as developing a food defense plan and records management.

The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Very small businesses are exempt from the rule, except for a documentation requirement described in the SECG, which has a compliance date of July 26, 2021.

Here you can find also an FDA fact sheet on the final rule on food defense.

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.

Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

In developing the rule, FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.
While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration, on the contrary,  is addressed in the final preventive controls rules for human and animal foods.

We already treated food defense topic in a previous post regarding EU situation.