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.

FVO reports – Import controls for plant health in Italy and Xylella fastidiosa crisis

In case you are still surprised about the Xylella fastidiosa outbreak in the Region Apulia, in the south of Italy, which between 2014 and 2015 nearly destroyed the Italian olives harvest, you should read the following Food and Veterinary Office’s reports (n. 2014-7327, Nov. 2014, 2015-7212, June 2015 and 2015-7580, Nov. 2015) and my former article about the topic, “Plant health: Xylella fastidiosa outbreak in Italy and damages to olive trees”.

The overall picture is still not encouraging after 2 years…

Plant health import controls

“This report (2015-7603) describes the outcome of an audit carried out in Italy from 8 to 17 September 2015. The objectives were to audit the capability and the performance of the official bodies responsible for import controls and the adequacy and effectiveness of import checks carried out for plant health purposes to ensure compliance with EU requirements.

Particular attention was paid to follow up on the action taken in Italy in response to the recommendations of previous reports. Overall, some progress has been made in Italy since the previous audit (2013). The planned (comprehensive) national computer-based manual of procedures has become operational recently. It has a significant potential to address a number of the weaknesses of the plant health import control system. Certain recommendations of the previous audits have now been satisfactorily addressed, and the actions planned in response to the remaining recommendations are ongoing, albeit with a delay.

Many of the shortcomings identified during the previous audit are still present, in particular, the shortage of resources, the lack of instructions and specific technical training to carry out meticulous plant health checks. In most of the regions visited, phytosanitary risks presented by the imported commodities are not taken into account and adequate inspection facilities, although available, are not used. Therefore, the current plant health import control system does not ensure that these controls are risk based and effective. This is reflected in the number of interceptions notified by Italy of imported plant consignments and of wood packaging material originating in all Third Countries which is low compared to the volume of trade.

Xylella fastidiosa (Nov. 2014 – follow up Feb. 2014)

This report (2014-7327) describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Italy, from 18 to 25 November 2014, following an earlier audit in February 2014.

The objective of the audit was to evaluate the plant health situation and control measures applied for Xylella fastidiosa (Well and Raju), in particular, the implementation of Commission Implementing Decision 2014/497/EU of 23 July 2014.

The audit team found that: Extensive human and financial resources have been made available for research and containment of Xylella fastidiosa, and there is a good level of awareness about the problem. With one exception, none of the eradication measures required by Decision 2014/497/EU, have been carried out. The situation has deteriorated since the last audit and Xylella fastidiosa continues to spread rapidly. The current Italian policy for the Infected Zone is now containment of Xylella fastidiosa and measures aiming at full eradication of the pest are not carried out. The current controls do not ensure that host plants not fulfilling the requirements of the EU Decision remain in the Demarcated Area. All the existing garden centres located in the Demarcated Area have not been identified and, therefore are not officially controlled. There is a possibility that not all host plant species have been identified and pathogenicity tests for a range of genera (including Vitis and Citrus) have not been concluded.

Until the precise host range of Xylella fastidiosa is known, the movement restrictions in place (although applied to a wider range of species than required in the Decision) do not provide adequate security that no infected plants leave the area. The proposed intensive surveys in the Eradication Zone, Buffer Zone and Security Zone, will help in the early detection of Xylella fastidiosa and enable the implementation of rapid eradication. This strategy could also limit the natural spread of the insect vector to new areas. However, taking into account the high populations and the passive mobility of the insect vector (vehicles, wind), the protective function of the two zones is questionable. There is a significant risk of further spreading of Xylella fastidiosa outside the Demarcated Area.

Xylella fastidiosa (June 2015)

This report (2015-7212) describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Italy from 8 to 19 June 2015. The objectives of the audit were to evaluate the plant health situation and control measures applied for Xylella fastidiosa in Italy and in particular, the implementation of Commission Implementing Decisions 2014/497/EU and 2015/789/EU.

The audit was carried out in addition to the planned FVO programme following a further significant and rapid spread of Xylella fastidiosa in Apulia in early spring 2015 and the declaration of a state of emergency by the Italian Council of Ministers of February 2015.

The authorities responsible for the official controls of Xylella fastidiosa have developed a plan for the implementation of national legislation and the EU Decisions, which provides a sound basis for the control of Xylella fastidiosa, including surveillance, agricultural measures to suppress the vectors, movement restrictions for plants, the eradication of new outbreaks and infected plants and communication with producers and stakeholders. The FVO team found no evidence at the time of the audit, of any critical technical, resource, or general legal constraints which would prevent the authorities from implementing these measures, especially since the declaration in February 2015 of a state of emergency for Xylella fastidiosa in the Apulia region.

However, it was found that many of these measures have only been partially implemented or not implemented at all. In particular, a total of only 111 trees have been destroyed in Apulia since the first confirmation of Xylella fastidiosa in 2013. In the specific case of the Oria outbreak, only seven of the 37 infected trees have been eradicated since the outbreak in March 2015. There are now 52 infected trees in that area. The existing programme of surveys is not effective to allow for the timely detection of new outbreaks or the accurate determination of the true extent of the spread of Xylella fastidiosa.

The measures implemented so far have clearly not been sufficient to prevent the further rapid spread of Xylella fastidiosa within the Demarcated Area and, in the absence of concerted action, and full implementation of the necessary measures and effective engagement with stakeholders, the further rapid onward expansion of the disease is inevitable.

Xylella fastidiosa (Nov. 2015)

This report (2015-7580) describes the outcome of an audit carried out by the Food and Veterinary Office (FVO) in Italy from 10 to 20 November 2015. The objective of the audit was to evaluate the situation and control measures applied for Xylella fastidiosa in Italy and in particular, the implementation of Commission Implementing Decision 2015/789/EU of 18 May 2015 setting out protective measures. The action taken to address the recommendations of the previous audit on this topic was also evaluated.

This was the fourth audit to Italy on this topic; it followed developments in the national measures for X. fastidiosa, including the adoption of an action plan, and a further significant and rapid spread of the disease. The audit found that there have been some positive developments since the previous audit on this topic in June 2015. An action plan, aimed at the eradication and containment of X. fastidiosa within the demarcated area, and supported by a revised legal basis and the payment of compensation for some of the losses arising from the removal of plants, was in place.

An annual survey for the presence of X. fastidiosa has been carried out, and no evidence of the presence of the disease outside of the demarcated area has been found. However, the limited number of sites monitored in the general territory reduces the reliability of the claimed lack of presence of X. fastidiosa on the territory. This is particularly so in the area of Puglia north of the surveillance zone, which is at the highest risk from the natural spread of the disease, but which was subject to no, or only minimal, inspections. Surveys have also been carried out in the demarcated area, however the level of visual inspections applied in the surveillance zone and buffer zone is very significantly below that required by Articles 8(2) and 6(7) of Decision 2015/789/EU. The existing programme of surveys still does not ensure the timely detection of new outbreaks or the accurate determination of the true extent of the spread of X. fastidiosa in the demarcated area.

Action is now being taken in response to findings of X. fastidiosa in the demarcated area. The felling programme, which is subject to a number of significant constraints, is ongoing, however there is still a very substantial number of infected plants and host plants within 100m radius of such plants to be removed, outside of the province of Lecce.

The limited removal of plants is not in compliance with Article 6(2) of Decision 2015/789/EU, which requires that such plants are immediately removed and destroyed. There is a similarly substantial number of infected plants in the containment zone, within a distance of 20km of the border of the Province of Lecce, which have also not been removed and destroyed immediately, as required by Article 7(2)(c) of the Decision. A significant number of the plants concerned are subject to ongoing legal appeals, however it is of real concern that so many infected plants, and plants at very high risk of infection remain in place, given the evident consequences for producers in the affected areas and the onward and rapid spread of the disease to new areas and new producers.

Unless effective eradication and containment measures are implemented, the further rapid spread of the disease throughout the region is inevitable.