EU Preliminary Impact Assessment on Trans Fats policy options

The EU Commission just published an inception impact assessment about a potential upcoming Regulation about limitation of trans fats in foods (3rd quarter 2017).

Although different actions were taken in different Member States of the EU and intakes of trans fats have overall decreased over the past years, other Member States have not taken action.

Industrial trans fats are still present at levels of concern in certain foods in the EU and intakes are still excessive in certain cases (especially having in mind EFSA’s recommendation that trans fats intakes should be as low as is possible within the context of a nutritionally adequate diet). The issue is of particular relevance in certain Member States and for particular population groups. This lack of homogeneity in the EU hampers the effective functioning of the Internal Market, negatively affects the protection of consumers’ health and contributes to the perpetuation of health inequalities.

The Commission is currently considering an EU-based initiative to limit trans fats intakes, which would have the added value of coherent and simultaneous application in the entire EU. This initiative would focus on industrial trans fats, given that ruminant trans fats sources generally contribute in a limited way to the total daily energy intake and ruminant trans fats are naturally present in foods that are important in the EU diet and cannot therefore totally be avoided.

The Commission presented its first analysis on trans fats in its report to the European Parliament and the Council of 3 December 2015 regarding trans fats in foods and in the overall diet of the Union population. The report was requested by Article 30(7) of Regulation (EU) No 1169/2011 of the European Parliament and the Council on the provision of food information to consumers which stated: “By 13 December 2014, the Commission, taking into account scientific evidence and experience acquired in Member States, shall submit a report on the presence of trans fats in foods and in the overall diet of the Union population. The aim of the report shall be to assess the impact of appropriate means that could enable consumers to make healthier food and overall dietary choices or that could promote the provision of healthier food options to consumers, including, among others, the provision of information on trans fats to consumers or restrictions on their use. The Commission shall accompany this report with a legislative proposal, if appropriate”.

The report concluded that a legal limit for industrial trans fats would be the most effective measure in terms of public health, consumer protection and compatibility with the Internal Market but that further investigation is required. In accordance with Better Regulation principles, the Commission communicated its intention to carry out an impact assessment, including a public consultation on the matter, in order to take an informed policy decision in the near future.

This Inception Impact Assessment (IIA) marks the beginning of the announced work of the European Commission.

All the stakeholders that intervened in the debate on trans fats so far have welcomed the Commission’s report and/or supported an EU initiative to set legal limits to industrial trans fats in foods, both on the consumers’ side and on the industry’s side. The issue would therefore appear not controversial and the added value of an EU initiative in the field would seem undisputed.

In several platforms, EU action on industrial trans fats has been defined by consumers’ organisations and food business operators as a “low hanging fruit” that would improve consumers’ health at very limited costs. In this context, of particular note are the number of reformulation commitments to lower the content of industrial trans fats in foods made in the past years by food manufacturers in the EU Platform for Diet, Physical Activity and Health.

The positions of industry stakeholders (well summarised in a statement by Food Drink Europe of 19 November 2015) 17 indicate that the industrial trans fats content of foods can effectively be lowered without disproportionate costs (this was confirmed in Denmark, the first Member State introducing a legal limit for industrial trans fats in foods), that an EU initiative would benefit not only to consumers but also to the industry by setting a level playing field in the Internal Market, and that particular support might be needed for SMEs.

In the EU, it is of particular note that legislative measures limiting the content of industrial trans fats to 2% of the total fat content of the food were adopted in Denmark (2003), Austria (2009), Hungary (2013) and Latvia (2015). In Belgium, Germany, the Netherlands, Poland, the UK and Greece, voluntary self-regulation measures have been agreed with the food industry. Legal measures limiting the content of industrial trans fats in foods exist also outside the EU (e.g. in Switzerland, Iceland, Norway as well as in the US, where the Food and Drug Administration concluded in 2015 that partially hydrogenated oils, the primary dietary source of industrial trans fats, are no longer to be considered as “generally recognized as safe” (GRAS) for use in food).

EU legislation sets legal limits for trans fats in infant formula and follow-on formula (3% of the total fat content of the food, to allow for the use of milk, which naturally contains ruminant trans fats, as a source of fat). Regulation (EU) No 1169/2011 requires since 13 December 2014 to specify in the ingredients list of all prepacked foods (non pre-packed foods are not covered by this provision) whether refined fats/oils are partly hydrogenated. The Regulation however does not require the indication of the exact trans fats content of foods in the nutrition declaration and they cannot even declared in the table on voluntary basis.

The options examined in this IIA, are the following:

  • Option 0 – No EU policy change (baseline scenario)
  • Option 1 – Establishment of a limit for the industrial trans fats content in foods

In this option, the EU would establish a limit for the presence of industrial trans fats in foods (both pre-packed and non-pre-packed), through voluntary agreement with relevant stakeholders or with legally binding measures.

  • Option 2 – Introduction of the obligation to indicate the trans fats content of foods in the nutrition declaration
  • Option 3 – Prohibition of the use of partly hydrogenated oils (PHO) in foods

In this option, the EU would follow the same approach as adopted in the US and would prohibit the use of PHOs in foods, on the basis of the consideration that these are the primary dietary source of industrial trans fats. As in the case of Option 1, this could be achieved through a voluntary agreement with the relevant food business operators, or a legally-binding measure

The following future consultations are planned in order to obtain further feedback in preparation for the Impact Assessment:

  • Open Public consultation (12 weeks): this consultation will be open to everyone and will be carried out on the basis of a consultation document that will take into account the comments submitted on the IIA. It will be aimed at obtaining feedback on the different policy options and the expected impacts.
  • Targeted consultation to be carried out by the contractor in the context of its study: this consultation will cover stakeholders with a specific interest in the initiative (consumers’ and health NGOs, food business operators and national authorities) and will be aimed at collecting feedback to triangulate (verify) the contractor’s findings on the expected impacts that the options finally retained for the Impact Assessment will have in a number of different areas (e.g. protection of consumers’ health, costs and regulatory burden, offer of products to consumers, functioning of the Internal Market, competitiveness, external trade, enforcement). The Commission will be particularly interested in collecting feedback at local level, from SMEs and manufacturers of non-pre-packed foods.

The last part of the IIA offers an interesting first evaluation of all the policy options impact on environment, economy, internal market, public health, SMEs, international trade and all the main stakeholders involved.

Canada – CFIA recognises a role for private standards within the regulatory framework

This interesting policy, released by the Canadian Food Inspection Agency (CFIA), has to be considered probably a “best practice” and I am sure in future we will see more and more similar public-private cooperation models.

Since the international private standards are so widely used in the food chain, and since they set higher standards then public regulations, why don’t we start to consider them as an helpful tool to prioritize official controls and optimise a risk based approach to food safety? Looking to the current globalisation and to the lack of resources that affect most of the competent authorities, it seems quite a reasonable option. This will be also an incentive to companies and private standard’s owners to ensure that their schemes are consistently implemented and auditing systems are effective. The application of a  recognised standard will result in less burdens and controls from the public competent authorities on the food business operator.

Here below some paragraphs from CFIA policy, that comes into effect on September 3rd, 2015.

Policy Statement

In determining the level of risk associated with a regulated party or their establishment, the CFIA may assess the requirements of a private certification scheme used by the regulated party against food safety regulatory requirements and factor the assessment results into its risk-based planning and prioritization.

It should be noted that there is no requirement by virtue of this policy for a regulated party to become certified to any private certification scheme nor does this negate regulatory oversight.

Objectives

  1. Support an understanding of voluntary, industry-adapted private certification schemes, and the role such private certification schemes may play in achieving compliance with CFIA food safety regulatory requirements;
  2. Provide direction on how industry’s investment in an appropriate private certification schemes will be considered within the CFIA risk-based regulatory framework; and
  3. Provide a foundation to inform future discussions on broader consideration of private certification schemes within the CFIA regulatory framework.

This policy aligns with the direction and requirements provided in the CFIA Program Policy Management Framework for the management of CFIA program policies.

Scope

As private certification has a much wider market penetration in food safety, and that the CFIA food safety program is more advanced in its modernization efforts, while initially this policy will apply to program design and delivery of CFIA‘s risk-based oversight of domestic and imported food, as it relates to food safety, the CFIA is committed to expanding the scope to other aspects (e.g. labelling) and the plant and animal health programs as applicable.

The CFIA will continue to explore other approaches to leveraging industry’s use of private certification schemes in support of public policy objectives.

Background

Private certification schemes are voluntary systems that set process and product requirements as well as the means of demonstrating conformity with these requirements. Companies implement private certification schemes to manage risk, facilitate effective management of products along the supply chain and differentiate products. In recognition of the importance of public endorsement by regulatory bodies, some private certification schemes have been developed with government support and regulatory oversight.

Private certification schemes are a prominent part of the world food supply system and are increasingly being used by industry as a means of achieving food safety and other outcomes. Demand for food safety private certification schemes comes from both the food industry and consumers.

There is a wide range of private certification schemes and many suppliers are facing requirements for multiple audits and certifications. As a result, international efforts are underway to harmonize private certification scheme requirements in order to help reduce costs and improve predictability in market requirements. With respect to food safety, there are global benchmarking initiatives such as the Global Food Safety Initiative (GFSI) and the International Federation of Organic Agriculture Movements (IFOAM) that provide a platform for collaboration between some of the world’s leading food safety experts from industry, international organizations, academia and government on global benchmarking of private certification schemes.

The Canadian Food Inspection Agency (CFIA) is transforming how it delivers its food safety programs and activities to better meet the needs of today’s consumer and industry. The CFIA recognizes that private certification schemes may play an important role in helping industry achieve food safety regulatory objectives, provided they can be assessed as being effective, credible and aligned with public policy objectives.

Private certification has been identified as one of several factors that CFIA will consider in its modernized approach to risk-based oversight. While the CFIA has always incorporated risk into its approach to food safety oversight, a modernized approach will enable improved risk-management by using private certification data to inform CFIA risk-based planning and prioritization within the regulatory framework, and as a resulting consequence, more targeted compliance verification.

Private certification is not intended to replace regulatory enforcement authorities; however, it may complement food safety regulatory oversight. The CFIA will continue to verify compliance of regulated parties; the type, frequency, and intensity of the CFIA‘s oversight activities will be proportional to the risks that need to be managed.

Changing Global Economy

The ways in which food, animals and plants are produced and marketed have changed dramatically. The complexity of the production and distribution landscape has increased, driven by changes in methods of production and processing and increases in international trade. As a result, the challenges of carrying out regulatory oversight are multiplying. Given the growing importance and prevalence of private certification systems, it is important and timely to understand the challenges and opportunities that they present to the CFIA.

Fixed Resource Base

Compounding the inherent complexities associated with a changing global economy, the CFIA is mandated to manage multiple demands and risks (e.g., safety, consumer protection, market access) across multiple sectors (i.e., food, plant, animal). Given that it operates within a fixed resource base, the Agency must optimize its resources by investing in priority areas (e.g. highest risk) and in areas that produce the most significant return (e.g. reduced risk) on investment of effort/resources.

Risk-Based Approach

With pressures from increased globalization and advances in science and technology, the CFIA is modernizing its approach to inspection to maintain a robust approach to human, animal and plant health and consumer protection. The move towards a more preventative and systems-based approach under the Integrated Agency Inspection Model (IAIM) enables both the CFIA and regulated parties to more readily adapt to emerging risks and global and scientific trends.

Furthermore, the CFIA is developing a systematic, transparent and documented method of comparing risks within and across its business lines in order to align strategies, priorities and resources accordingly. This will be accomplished through the development of the CFIA Integrated Risk Management (IRM) Framework.

Expanding Authorities in Food

Currently, the CFIA can license register establishments for activities that relate to some food commodities The new Safe Food for Canadians Act includes provisions that will enable the CFIA to use licensing and registration for all food commodities. In particular, the current non-federally registered sector is a large and diverse food sector that has not previously been subject to CFIA registration or licensing requirements. With an estimated 50,000 regulated parties, many of whom were previously unknown to the Agency, this sector alone represents a significant increase to the number of establishments for which the Agency must consider in its risk-based oversight. It is anticipated that many of these establishments will have implemented a type of private certification scheme. Certification to a private scheme that has been assessed as meeting some or all regulatory requirements will be extremely useful information in assessing risk and determining appropriate regulatory response and oversight for all food commodities.

Existing Agency Initiatives

There are several existing Agency initiatives that have informed the development and implementation of successful programming in support of this policy such as the Food Safety Recognition Program (FSRP), the CFIA use of the Animal Nutrition Association of Canada Feed Assure program, the Canada Organic Regime and Seed Certification System. The FSRP will be particularly instrumental to the development of programming in support of this policy.

The FSRP process involves an evaluation of the technical soundness and administrative effectiveness of food safety systems developed and implemented by Canada’s national (or equivalent) industry organizations. National food industry organizations from the on-farm or post-farm non-federally registered sectors can voluntarily submit their food safety systems to the CFIA FSRP team.

To date, the CFIA has not taken the investments companies have made in the FSRP into consideration in its risk-based oversight approach. The CFIA Private Certification Policy (Food Safety) will be a bridge between the FSRP and theCFIA risk-based oversight.

(Source: CFIA website)