14.8.2015   

EN

Official Journal of the European Union

C 268/1

Rapporteur:

Igor ŠARMÍR

1.1.

The European Economic and Social Committee (EESC) appreciates that food safety is one of the European Union’s priorities and that a robust system to guarantee it has been put in place. It particularly welcomes the fact that since 2002 food safety in the EU has come under the authority of a specialised agency, the European Food Safety Authority (EFSA), which has all the means necessary to assess the safety of products placed on the European market.

1.2.

The EESC believes that the EFSA has proved that it is competent throughout its existence. There is no doubt that it plays a very important role in preventing health risks in Europe. Thanks to the EFSA, the EU has one of the most effective systems for protecting public health in the world. However, given that public health is an extremely sensitive subject and that consumer confidence is a major concern for the EFSA, further steps must be taken to study how the current system can be improved, especially in light of the new questions raised by science. With a view to meeting this objective, the EESC wishes to make several proposals.

1.3.

The transparency of the procedure for assessing new products due to enter the food chain, including chemical and other products, is without doubt an important condition for ensuring consumer confidence in the system and the products being tested. The EESC believes that some improvements are possible in this area. For example, statutory studies submitted by manufacturers, which must prove that the product concerned is harmless, are not published in scientific journals and not only does the scientific community not have routine access to the raw data from these studies, but trade secrecy has been overtly invoked in several cases. The EESC is convinced that this is not legally sound, since, according to the EFSA itself, data from statutory studies is not of a confidential nature.

1.4.

The EESC calls on the European Commission to start making appropriate changes to the rules on this matter making it compulsory for the statutory studies concerned and the raw data from these studies to be disclosed on the EFSA’s website as a matter of routine, once it has completed its assessment.

1.5.

The EESC welcomes the recent initiatives taken to publish information in a proactive way.

1.6.

In the past, the agency has found itself in a delicate situation as a result of the conflicts of interest of some of its experts. The EESC welcomes the steps taken by the EFSA in 2012 to normalise the situation but recommends keeping a careful eye on the matter because of the extremely sensitive nature of this aspect of the official assessment.

1.7.

EFSA’s work is complicated by the existence of scientific studies whose findings are clearly influenced by the source of their funding and which could invite considerable controversy. The EESC recommends that the EFSA pay special attention to this practice, since scientific literature is an important reference point for the assessment procedure.

1.8.

The EESC congratulates the EFSA on its considerable efforts over several years to achieve a better understanding of the effect of mixtures and to develop new methodologies which can be used during the assessment procedure, and encourages the EFSA to implement them as soon as possible.

1.9.

The EESC recommends adopting a cautious approach as regards the application of the principle that ‘the dose makes the poison’, since for 20 years many endocrinologists have being providing evidence that, for substances known as ‘endocrine disruptors’, the key variable is not the dose, but the moment of exposure. The regulatory framework has yet to take account of this new data, as flagged up in a recent European Parliament report (1).

1.10.

The EESC recommends that the European Commission draw up, after consulting endocrinologists, a list of products that may have a negative impact on the development of the endocrine system. The EESC urges the European Commission to apply the precautionary principle to substances on this list, pending a consensus within the scientific community on whether they pose a hormonal risk or are harmless.

1.11.

The importation of pests and diseases from third countries can have dramatic consequences for producers and consumers in the European Union. Stronger border controls, application of the reciprocity principle and a political willingness on the part of the European authorities are vital if the system’s consistency is to be guaranteed.

1.12.

The EU must ensure that it can rely on a trade system that does not undermine food safety guarantees for Europeans. The review of legislation on plant and animal health is an opportunity to improve the implementation of the control systems, to apply them in a uniform way and to curb the adverse social, environmental and economic impact.

1.13.

The EESC calls for foods to be made fully traceable ‘from farm to fork’ (including imported foods) so that consumers are able to select foods of a certain quality and which meet current EU safety standards.

2.1.

This opinion deals with two slightly different subjects, which nevertheless have a common denominator: reassuring European society about the availability of safe food. The first part of the opinion is about the current system for assessing new products intended to enter the food chain while the second part seeks to flag up certain issues which international trade relating to agri-food goods poses for farmers, on the one hand, and consumers and the general public, on the other.

2.2.

Food safety is one of the EU’s official priorities and, from an institutional point of view, is undoubtedly ensured in an effective way by the European Commission and the EFSA. There can be no denying that any microbiological risks are now firmly under control. During the course of the 20th century, however, alongside microbiological risks appeared chemical risks, a field in which the situation is far less clear-cut.

2.3.

Over the past 60 years, more than 1 00  000 new substances, produced by synthetic chemistry, have been released into the environment. In spite of this, only a negligible proportion (1-2 %) have been assessed in terms of possible risks to human health (2). This is concerning from the point of view of food safety, among other things. Apart from the substances which enter the food chain directly (additives, residues of pesticides or plastics) and which are in principle subject to the assessment procedure, other substances can enter the food chain indirectly via soil, air and water.

2.4.

After being used and consumed for long periods of time, some longer than others, a number of man-made chemical products have already been withdrawn from the market because their toxicity and/or carcinogenic properties have been scientifically proven (see for example point 2.5). However, other products still have not been banned despite scientists’ suspicions which are, to a greater or lesser extent, well founded. It is therefore perfectly legitimate to look into a possible link between the exposure of the human population to these new man-made chemical products, on the one hand, and on the other, the astronomic increase in developed countries of cases of cancer, and neurodegenerative diseases, as well as sterility, diabetes and obesity.

2.5.

The EU has put in place a robust system to prevent risks associated with the entry of new products, including chemical products, into the food chain. At an institutional level, the European Commission (DG SANTÉ) is responsible for risk management, whilst the EFSA, the European agency with authority for technical matters, is responsible for risk assessment. Implementation of the new system has already yielded some reassuring results for consumers: for example, following in-depth assessments, the number of pesticides authorised in the EU fell dramatically between 2000 and 2008 (from 1  000 to 250). However, it is a worrying development for farmers, who are beginning to feel the effects of the absence of active substances allowing them to carry out pest control. Paradoxically, many of these active substances which are banned in the EU are permitted in third countries which export their produce to the European market.

2.6.

Despite the existence of a robust system, experience has shown that some aspects of the assessment process can still be improved, especially as new scientific discoveries and their commercial applications often pose new challenges for the evaluation procedure. These challenges are of a systemic and methodological nature.

3.1.

The EFSA assessment is based on a scientific study which should demonstrate that a particular product is harmless. Under current legislation, this baseline study has to be presented by the requesting party, i.e. the company wishing to put the product on the market. This in itself offers little in the way of reassurance because the findings of scientific studies can differ radically depending on their sources of funding (see point 3.4). However, it is true that EU rules applied by the EFSA provide for conditions which these studies must comply with, as well as, for the subsequent stages of the assessment procedure, mechanisms to act as a counterweight to the practice described above.

3.2.

Another problem with the assessment procedure is the confidentiality surrounding these statutory studies, which seems to be controversial. They are not published in scientific journals and the raw data are often covered by the ‘trade secret’, preventing the scientific community from conducting any counter-expertise (3). We realise that trade secrets must be used to protect data and information relating to new products which could reveal either the composition of the products or the way in which they were manufactured. However, this is not the case with data from statutory studies, which do no more than report on how guinea pigs react after having consumed the products being tested. Since in this case the use of trade secrets is not justified by the protection of the legitimate interests of producers (4), the EESC considers this to be unfair and calls for legislation to be adapted to make raw data from statutory studies systematically available to the scientific community (on the Agency’s website), once the assessment has been carried out by EFSA.

3.3.

The EFSA is a public agency set up to provide independent scientific assessments of new products forming part of foodstuffs. In the past, however, the agency was criticised because of the conflicts of interest of some of its experts. In most cases, they were also ILSI consultants (5). The EESC welcomes the fact that in 2012 the EFSA made a major effort to solve this problem, meaning that the situation is now back to normal. Given its sensitive nature, the EESC recommends keeping a close eye on this matter.

3.4.

In the course of conducting assessments, the competent agencies also refer to relevant studies published in the scientific literature. However, it has been proved that the results of scientific studies can differ radically depending on the sources of funding (6). The independence of researchers is key to ensuring the sustainability of the system, and the task of the EFSA is complicated by the need to distinguish between high-level scientific studies and those whose value is questionable because of methodological or other errors.

4.1.

The methodology for assessing chemical products that may be used in foodstuffs is based on the Paracelsus principle. According to this principle, ‘all things are poison and nothing is without poison; only the dose makes a thing poison’. For each product, then, all that is necessary is to calculate an ‘acceptable daily intake’ or ADI. In other words, the great majority of new products can be consumed on a daily basis, provided the amounts are not in excess of a fixed dose.

4.2.

For centuries, the application of Paracelsus’ principle could be taken to be reliable. However, the new man-made substances, included in foodstuffs for several decades, represent a fresh challenge and Paracelsus’ principle can no longer be applied blindly.

4.3.

The first problem to arise is how to manage the food intake of individuals. Consumers are in fact completely unaware of the existence of the ADI and, as a result, do not even have the theoretical possibility of checking whether they are consuming more than the ‘authorised’ amount of a particular substance that may be contained in a range of foods that they consume on a daily basis (7). The reality is that the concept remains scientific and highly technical and is used only by a narrow circle of specialists.

4.4.

The human organism is not exposed to a single chemical substance, however, but to a large number of residues of pesticides, plastics and food additives that are also found in foodstuffs. Moreover, the ADI is calculated only for each individual chemical substance, without taking account of a possible cumulative or synergistic effect. Unfortunately, this effect is far from being purely hypothetical: on the contrary, a number of studies have already shown that the cumulative action of several substances can have serious consequences, even though they have tested as harmless individually (8).

4.5.

The agencies responsible for assessing potentially harmful products, such as the EFSA or the FDA in the United States, have been studying the cumulative and synergistic effects for several years but the fruits of their efforts have not yet been translated into legislation (9). This is due to scientific difficulties and the complexity of this task. However, the EFSA has declared that it is quite close to having scientific knowledge in the field translated into regulation and the EESC urges it to do so as soon as possible.

4.6.

Lastly, the principle of Paracelsus has been called into question by the phenomenon of ‘endocrine disruptors’. These are substances that tend to mimic the action of hormones, especially the female hormone oestrogen. According to many endocrinologists, they frequently have an adverse effect even when the organism is exposed to significantly lower quantities than the ADI and it is not even possible to set a threshold under which they would not be harmful (10). It has been demonstrated that the critical variable in the case of endocrine disruptors is not the dose but the moment of exposure. In this instance, the most dangerous period is when the endocrine system is developing (prenatal life, early childhood and puberty). Another particular feature of endocrine disruptors is that their toxicity may become apparent several years or even several decades after exposure.

4.7.

A considerable number of substances, both natural and man-made, are now considered by endocrinologists to be endocrine disruptors, and many of them are frequently contained in food products for human consumption. These include various pesticides, dioxins, PCBs and phthalates, for example, but the most heated debate today surrounds the packaging material bisphenol A (11).

4.8.

There is evidence that endocrine disruptors play a key role in the alarming decline in male fertility (a phenomenon which has been observed since the Second World War), and have contributed to the significant increase in testicular and prostate cancer in men and breast cancer in women, as well as other serious diseases (12).

4.9.

The competent European bodies, namely the EFSA and DG SANTÉ, hesitate to take the steps which have been strongly recommended by endocrinologists because the scientific community is split over whether very low doses are harmful (13). However, many of the scientists who carry out original research in endocrinology believe that very low doses of substances identified by them as endocrine disruptors have a very dangerous effect, especially on pregnant women and small children. For them, this is beyond doubt and has been proven by ‘thousands of scientific studies’ (14), whereas for the EFSA the idea that very low doses do have an impact is purely hypothetical.

4.10.

Following the comprehensive report (15) commissioned by DG ENV which confirmed the opinion of the endocrinologists, in October 2012 DG SANTÉ invited the EFSA to reflect on the criteria for defining endocrine disrupters, and to assess the relevance of the testing methods which exist in this area. However, these steps have yet to be taken and, for the time being, the European Commission is proposing only a roadmap which paves the way for a definition of endocrine disruptors (16). The task itself has therefore been postponed until late 2016.

4.11.

Endocrinologists have repeatedly made it known that they disagree with the EFSA and other advisory or regulatory bodies in respect of endocrine disruptors, not least by means of the declaration of consensus published by the American Endocrinology Society, which has more than 1  000 members (17), at the international seminar held in Berlin in September 2012, and the Berlaymont Declaration issued in May 2013 (18). All signatories of that declaration were specialists who actively publish work on the subject and believed that, as a matter of priority, EU legislation should begin to take account of the knowledge accumulated over the years. For example, the latest pesticide regulation of March 2013 provides for mandatory tests to determine whether a new product is, among other things, mutagenic, but not to assess its hormonal activity. This illustrates that the concerns of endocrinologists are still far from being taken seriously by the competent authorities.

4.12.

The EESC believes that regulation should, as a matter of urgency, start to take account of knowledge accumulated in the field of endocrinology, and thus agrees with the European Parliament’s (19) position. Even if the ‘wider scientific community’ is split, the opinion of many endocrinologists should provide ample justification for, at the very least, applying the precautionary principle to substances identified by endocrinologists as endocrine disruptors.

5.1.

The World Trade Organisation (WTO) requires its members to conduct negotiations to continue and facilitate trade in agricultural produce, entailing substantial and progressive reductions in domestic subsidies and protection for their products in the interest of promoting ever greater liberalisation.

5.2.

Against the backdrop of an increasingly liberalised global market, with trade in plant products becoming more and more common, spurred on by the trade agreements that the EU is constantly signing with third countries, there is a heightened risk of new pests and diseases being introduced into Europe.

5.3.

There is great concern and fear on the part of European producers regarding the entry of harmful agents, many of which are extremely hazardous and are not yet established in Europe. The entry and propagation of some of these agents could cause a sharp fall in various areas of European production resulting, particularly in the case of minority crops, in severe financial losses for producers.

5.4.

The entry of foreign pests and diseases not endemic to the EU would, in addition to posing a threat to certain agricultural products, lead to a rise in production costs for European farmers and consequently a decline in the profitability of farms. They could also have a major economic, environmental or social impact across the European continent.

5.5.

We would cite, by way of a practical example that clearly and unequivocally shows the gravity of the problem, the recent case of citrus fruit imported from South Africa. During the last season, a significant number of shipments of South African citrus fruit arriving in European ports were contaminated by a dangerous fungus, Guignardia citricarpa (black spot). In the event, 35 shipments of imported South African citrus fruit containing the pathogen were intercepted.

5.6.

This shows how lax regulations in the EU are putting 5 00  000 hectares of European citrus-growing areas at risk, as there is no known treatment for effectively eradicating the disease. If introduced into Europe, it would have extremely adverse economic, environmental and social repercussions, jeopardising the security of food supplies.

5.7.

The draft regulation on plant health is an improvement on Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (20), however, it continues to overlook some aspects of vital importance, meaning that many outstanding problems still lack a solution.

5.8.

It should also be pointed out that production conditions for imports from third countries are not the same as those in force in the EU. Third countries allow the use of many plant health products that are banned in the EU, MRLs (maximum residue limits) are higher than those allowed in Europe and social and working conditions are quite different (lower levels of protection, if any).

5.9.

From the point of view of the European consumer, it must be stressed that in terms of safety and traceability, there is a patent difference between goods of external origin and those produced in the EU.

5.10.

Current legislation limits or restricts the use of an increasing number of active substances used to treat certain pests and diseases. Restrictions imposed on European farmers could affect up to 50 % of the products available over the last few years. At the same time, there has been an increase in requirements concerning the individuals applying such products, in that they have to undergo greater training and make use of more protective measures during treatment.

5.11.

The principle of reciprocity should ensure that all produce sold on the same market is subject to the same obligations or standards as those applicable in Europe (health security, eco-conditionality and use of active substances, etc.).