The new European regulation on organic farming


On May 30, 2018, the European Parliament and the Council of the European Union adopted Regulation 848 of 2018 relating to organic production and labeling of organic products and which repeals Regulation (EC) no. 834/2007 of the Council, the application of which is postponed to January 1, 2021.

The new regulation on organic production, in addition to repealing the previous regulation of the European Parliament and of the European Council 834/2007, created the need to amend Regulation 889/2008 laying down methods of application of Regulation (EC) no. 834/2007 of the Council relating to organic production and labeling of organic products, as regards organic production, labeling and controls, which was therefore integrated with the provisions of the Implementing Regulation n 1584/20181.
The desire to introduce changes to the European regulations on organic farming had already manifested itself several years ago, as a result of the considerable increase in demand for organic products. In a short time, in fact, the organic market has gone from being a niche sector to being a valid and accessible alternative for the consumer, compared to the conventional product market. The sharp increase in the demand for organic products has highlighted the need to adopt a more uniform discipline in all the states of the European Union. For this reason, after about 4 years of discussions and comparisons (the proposed revision of the organic regulation dates back to March 2014), the text in question was adopted, which, however, contains many of the exceptions already present in the regulation currently in application, which however - it is hoped - will be progressively abandoned.

The difficulty of finding a balance between the harmonization needs of European regulations and the need to leave room for individual member states to adopt their own internal rules, which are able to guarantee the protection of cultural and technical particularities, constitutes an important issue that permeates much of the law of the European Union. What, from a structural point of view, translates into the question about the will and the opportunity of individual member states to renounce part of their sovereignty in favor of a third body (the Union), in the more pragmatic context of technical regulation it translates into the delicate task of the European legislator to carefully calibrate the needs of the single market with those of the individual particularities of the individual member states to be evaluated sector by sector.

In particular, in the context of intra-European trade in food products, the need to balance the principle of mutual recognition with the adoption of a harmonized European discipline has emerged, both from the point of view of food safety and from that of the protection of certifications. of quality, both in relation to the regulation of organic discipline and in other respects.

With reference to the latter case, with this work, after a brief historical excursus, we intend to briefly retrace some of the main innovations of the new biological discipline. Through the analysis of a practical case, a reflection is proposed on what are, in the context of the regulation on organic production, the interests at stake that the European legislator must reconcile.

Historical Excursus on Organic farming

The concept of organic farming originates, from a theoretical point of view, from the work of the esoteric philosopher Rudolf Steiner (founder of anthroposophy) who in 1924 devised the basic principles of biodynamic agriculture.

In a historical context in which the spread of pesticides and chemical agents in agriculture was increasing rapidly, part of small and medium-sized farmers felt the need to adopt an alternative system, aimed at increasing the productivity of agricultural land while guaranteeing respect for the environment: in responding to such requests, Steiner devised the biodynamic farming method.

Mainly based on the three golden principles of maintaining the fertility of the earth, increasing the ability of plants to resist disease and parasites, and the production of healthy and quality food, the biodynamic philosophy has given rise to an alternative way of carrying out agricultural activity which, although in many respects coincides with organic production, differs from this for a greater rigor and for a broader vision of agricultural activity. Although both the organic and biodynamic currents prohibit the use of pesticides and chemical agents in agriculture, and promote agricultural techniques aimed at guaranteeing respect for nature, the former can be defined as a cultivation method (or from the point of view of market, a system certification), the second is instead a real way of life.

From the biodynamic school, therefore, originates the organic method, which over time has acquired more and more autonomy, outlining its identity in a more and more precise way. In fact, around the early 1970s, various small and medium-sized farmers began to aggregate into organized groups which subsequently formed sector associations, in order to formulate their own regulations inspired by organic principles. Faced with such a varied and fragmented reality made up of a multitude of small industry associations each with its own specification, the need arose to give uniformity to the biological material. In this regard, the International Federation of Organic Agriculture Movements (IFOAM) was established, which in 1982 adopted the "Standards of organic agriculture for international and national trade". The work of IFOAM was the starting point from which the European legislator, at the beginning of the 90s, took inspiration to outline the first European regulation on organic.2 For the first time in Europe, the EEC regulation 2092/91 gave legal value to the concept of organic farming, starting a process of regulating it.

It is important to note that the legal basis of Regulation 2092/91 was art. 43 of the TFEU3 for which its adoption was totally attributable to the category of regulatory instruments used by the European Commission in the context of the Common Agricultural Policy (CAP)4. Not surprisingly, the European legislator grants attention and protection to the instances of autonomous movements of organic farmers, just at a time when the CAP strategies had created a surplus of agricultural products on the market. Consequently, the prices of agricultural products had decreased creating the need to adopt forced purchasing policies in order to guarantee market stability and ensure a decent income for farmers. Organic products, being the result of less intensive and less profitable cultivation techniques, had a higher price than competing conventional products, which is why, with recital 1 of the regulation in question, the European legislator recognized the promotion and regulation of organic farming also has the function of "reorienting the common agricultural policy with regard to achieving a better balance between the supply and demand for agricultural products".

The first discipline on organic appeared immediately as an extremely fragmented system due to the numerous corrections and additions that have been made over the years (about 70 changes). This legislation was also not very effective in the face of the need to increasingly strictly regulate a growing market such as that of organic farming which, among other things, had to deal with the important innovations introduced by the European Community in the field of food safety.6

For these reasons, in 2007, the European legislator adopted Council Regulation 834/2007 of 28 June 2007 on organic production and labeling of organic products and which repeals Regulation (EEC) no. 2092/91, which in addition to extending the scope of application of the organic legislation also to the vegetable production of seaweed, animal production and aquaculture, marked an important reversal of perspective in the relationship between organic farming and the internal market. In fact, if before the organic sector was interpreted as a tool to support the CAP, in 2007 greater importance was given to the objectives of the organic philosophy. In fact, some recitals of the regulation include among the principles of the new discipline: the protection of the environment, the maintenance of a high level of biodiversity, the protection of animal welfare and the protection of natural resources7.

In addition, the introduction of a more coordinated and uniform regulatory system has facilitated the functioning of the internal market, as well as has made it possible to reduce the phenomena of unfair competition and obstacles to intra-community trade.

The organic discipline applies to both primary and processed products. In this last case, however, it is necessary that at least 95% of the products of agricultural origin are organic. The control system of organic products is established on a national basis, each member state designates the competent authority for certification, which in Italy is the Ministry of Agricultural, Food and Forestry Policies (MiPAAF), which in turn manages the individual bodies of control dependent on it.Each control body, which must be third and independent, is identified by an alphanumeric code that must appear on the food label together with the organic logo and the words "bio".Specific rules on the labeling of organic products are contained in Regulation 889/2008.

Organic certification is a process certification, as it aims to ensure that producers have adopted a certain production method in carrying out their agricultural activity, while no assurance is given regarding the characteristics of the final product. In other words, organic certification does not aim to differentiate organic foods from conventional ones, certifying a difference on a nutritional or organoleptic level, differences that according to the state of the art of studies on organic products are not scientifically demonstrable for all organic production. Undoubtedly, conventional products will very often appear to the consumer as more aesthetically homogeneous9 and more similar in taste than their biological counterparts, however, these observations are not supported by scientific grounds.

The new Regulation 848/2018 introduces itself in a regulatory context that is already fairly structured and defined, proposing to improve this system in order to increase consumer confidence in the organic market, through more transparent certification and control mechanisms that will lead to an increase in quality. of organic products10. The development of an agricultural production system based on respect for natural resources and sustainable development is in perfect continuity with the principles of the 2014-2020 CAP and the definition of an increasingly uniform and harmonized discipline will make it possible to overcome the extreme flexibility that characterized the previous Regulation 834/2007.

The new Organic Regulation, which will be applied from 1 January 2021, is presented as a regulatory intervention aimed at introducing important changes, always in the sense of making the discipline even more harmonized. In this regard, some innovations are noted that will be briefly analyzed below: the modification of the import-export regime, the introduction of group certifications, the change in the frequency of checks, the prohibition of soilless cultivation with relative derogation for some Northern European countries (Denmark, Sweden and Finland), as well as the introduction of a different approach to the thresholds of accidental contamination.

The import - export regime

The discipline currently in force, i.e. Regulation 834/2007, established the principle of equivalence between organic products made in the European Union and those from third countries, with the consequence that products recognized as organic outside the Union can circulate in the internal market with the qualification of organic products, regardless of the content of the legislation on organic farming in force in the country of origin. In other words, a product that can validly be certified as organic in a third country can circulate and be sold in the European territory as an organic product, even if the discipline of that country on the subject is less restrictive than the European one: two products, both organic, from a Member State and a third country are considered equivalent. This legislative choice underlies a clear pitfall, namely: a serious risk of prejudice to European organic producers who are subject to much more stringent legislation than that of many other third countries. In this regard, the new Regulation introduced the principle of conformity11 in place of the principle of equivalence, whereby the products to be imported into the internal market must necessarily comply with European standards after the transitional period, except for products from countries with which the European Union has entered into a bilateral trade agreement. The adoption of the compliance principle is, therefore, an innovation of crucial importance, although its significance will be more clearly perceptible only after the end of the transition period12.

Group certifications

Often small and medium-sized agricultural enterprises are currently neither able to meet the expenses necessary to obtain organic certification nor are they able to set up an administrative organization such as to be suitable for certification. In order to promote the organic market even among smaller farms, the new European regulation has introduced the possibility of requesting collective certification for groups of farmers who meet certain requirements13: the geographical proximity of the operators and therefore the proximity of the land, as well as a common system of marketing of organic products obtained by all members of the group, and an annual turnover of organic production not exceeding 25,000 euros or in any case a production standard not exceeding 15,000 euros. For the sake of completeness, it should be noted that the group certification system was devised by IFOAM, even before the European Union formulated any type of regulation on organic farming, however it was an entirely private system14.

The new control system, the ban on soilless cultivation and a different approach to the thresholds of accidental contamination

The new regulation introduces a facilitated control system for those operators in the food sector (FBO) whose products in the previous three years have been found to comply with all the standards of the organic discipline in each annual check: with the consequent advantage that the same products will be subjected to checks every two years instead of being checked annually.
For the rest of the operators, the annual controls have remained fixed, which will be added to those generally envisaged for all food products by the new Regulation on official controls no. 625/2017.
As regards, however, the derogation from the obligation to cultivate on the soil, granted by Annex II paragraph 1.5 of the regulation in question, which expressly provides for the possibility of cultivating in demarcated flower beds only for areas certified as organic in some member states , cannot deny that this exception hinders the implementation of an increasingly uniform discipline on organic farming. The connection between product and soil is considered one of the pillars of organic agriculture, however, due to a lack of regulation in this sense, several Northern European states have certified as organic products made with crops in demarcated flower beds for years, and the new organic regulation has granted these countries (Finland, Sweden and Denmark) an extension period of an additional 10 years, only for areas certified as organic for the purposes of this practice before June 28, 2017, so it is not allowed the extension of these surfaces15.
Another topic of discussion is the decision of the European legislator to adopt a not very brave solution on the issue of the thresholds for the presence of chemicals not authorized by organic farming in the event of accidental contamination16.
In fact, one of the most critical aspects concerns the fact that a maximum European threshold of chemical agents allowed in biological products is not established, and therefore, the individual member states remain free to adopt their autonomous contamination thresholds with internal regulations as long as these measures are not an obstacle to the movement of goods.
Although, therefore, the approach introduced is aimed at making the matter of contamination more uniform, to date a completely harmonized result has not been achieved. The legislator, in fact, recalled numerous actions that the organic producer must implement in order to minimize the cases of contamination of organic products, such as the adoption of measures aimed at assessing the risks and updating them periodically. However, European countries that define very stringent thresholds (such as, for example, Italy) end up being penalized by the lack of European legislation on this point.
Pursuant to art. 28, par. 3, the Commission is empowered to formulate implementing acts aimed at establishing uniform rules on anti-contamination measures in the various states. In any case, this is a non-definitive choice17: four years after the application of the Regulation in question, the European Commission will evaluate the effectiveness of the provisions on contamination, the various regulations adopted by the individual member states and possibly promote the introduction of a fully harmonized system.

A practical case is the organic certification of baby food

The discipline on organic agriculture (both the one currently in force and the new Regulation) allows only products to be labeled as "organic" that faithfully comply with the methods of production indicated in the regulations (absence of chemicals in the production of the product, absence of of pesticides, for processed products when at least 95% of the agricultural ingredients of the product by weight are organic).
Both disciplines provide that the addition of vitamins and mineral salts to organic products is only possible in some limited cases, when this is expressly permitted by law. Here we will analyze the possibility of adding vitamins and mineral salts, while maintaining the certification of organic foods to specific products, the so-called "growth milks" as well as to other foods intended for consumption by children. The current discipline or regulation 834/2007 together with regulation 889/2008 will be compared with the new regulation introduced by regulation 848/2018 and anticipated in some respects by regulation 1584/2018.
Growth milks (or formulas for infants in infancy) fall into the broader category of foods intended for consumption by children, although unlike all the other products that make up the so-called "baby food", they have never been regulated by the European legislator.
However, infant formulas “can be described as specifically processed / formulated protein drinks designed to meet the nutritional needs of 1 to 3 year olds”18. Since these products are not expressly regulated, the energy content and their composition are variable, even if in most cases the main source of protein is constituted by cow's milk, although generally the protein content of growth milks is lower than that of milk. traditional. Manufacturers often deem it appropriate to maintain the level of protein content within the limits permitted by legislation for infant and follow-on formulas indicated in Directive 2006/141 / EC (which will remain applicable until 21 February 2021 only regarding infant formulas. and follow-on formulas based on protein hydrolysates.) The formulas for young children are enriched with some micronutrients (for example iron and vitamin D) and polyunsaturated fatty acids, they may contain different sugars, sometimes honey and, in some cases, aromas normally present in infant and follow-on formulas, as well as other substances that are permitted in infant or follow-on formulas but which are absent in cow's milk.
At this point it will be necessary to provide some clarifications on the legal definitions that are relevant in the present case.
They are defined as:
-lactants: babies from 0 to 12 months;
- early childhood children: children between 12 months and 3 years old,
- infant formula: food products intended for consumption by infants between 0 and 6 months
- follow-on formula: products intended for the particular nutrition of infants after the sixth month of life,
- early childhood food: a food product intended to meet the specific needs of healthy infants during weaning and healthy infants to supplement their diets and / or gradually accustom them to an ordinary diet, excluding food for special medical purposes:19
Already in the previous formulation of reg. 889/200820, article 2721, paragraph 1, in implementation of art. 19, par. 2 lett. b) of regulation 834/2007, specified the conditions of use of particular substances in processed products, regulating, among others, also the added vitamins and mineral salts that could be used in organic production "only if their use is required by law in the foods in which they are incorporated ".
The formulation of the article just reported remained somewhat general and the meaning to be given to it was left to the reading that the interpreter intended to provide. While in the case of growth milks, since there was no type of legislation governing them, it was not difficult to exclude them from the possibility of organic certification, the same could not be said for other foods.
More complex interpretative issues have arisen, in fact, with regard to other baby food products, or for infant formulas or follow-on formulas for which, pursuant to EC Directive 2006/141, there is a legal obligation to add vitamins and minerals imposed in a manner indirect, as well as for processed cereal-based foods and other foods for infants ex dir. EC 2006/125 for which, equally indirectly, the addition of some vitamins and minerals is required by the standard itself. In fact, since art. 27 of regulation 889/2008 did not contain a clear list in a positive sense of the cases in which the organic product could be added with vitamins and mineral salts, this provision lent itself to the different interpretations of the individual member states. In particular, in Italy a restrictive interpretation of this article had been adopted, which, therefore, prohibited the organic certification of food added unless a specific rule of domestic or European law explicitly defined the addition as mandatory. This interpretation was based on what the European Court of Justice had established in 2014 which specified: "Article 27, paragraph 1, letter f), of Regulation (EC) no. 889/2008 of the Commission, of 5 September 2008, laying down detailed rules for the application of Regulation (EC) no. 834/2007 of the Council on organic production and labeling of organic products, as regards organic production, labeling and controls, must be interpreted as meaning that the use of a substance covered by this provision is required by law only on condition that a rule of Union law or a rule of national law complying with the latter directly requires the addition of that substance to a foodstuff in order for the latter to be marketed in general. The use of such a substance is not required by law, pursuant to the aforementioned provision, when a food product is marketed as a food supplement, bearing nutrition and health claims or as a food product intended for a particular diet, despite this implying that , to comply with the provisions relating to the incorporation of substances in foodstuffs which appear, respectively.

–In Directive 2002/46 / EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, as amended by Regulation (EC) no. 1137/2008 of the European Parliament and of the Council, of 22 October 2008, - in regulations (EC) no. 1924/2006 of the European Parliament and of the Council, of 20 December 2006, relating to nutrition and health claims made on food products, and (EU) no. 432/2012 of the Commission, of 16 May 2012, concerning the compilation of a list of permitted health claims on food products, other than those referring to the reduction of disease risks and the development and health of children, as well as - in the directive 2009/39 / EC of the European Parliament and of the Council, of 6 May 2009, relating to foodstuffs intended for particular nutritional uses, and in Regulation (EC) no. 953/2009 of the Commission, of 13 October 2009, relating to substances that can be added for specific nutritional purposes to food products intended for particular diets, such food product must contain a specific quantity of the substance in question22.
Although in the sentence reported no specific mention was made regarding alimony pursuant to EC directive 2006/125 and dir. CE / 2006/141, the Ministry of Agriculture (Mipaaf) had interpreted this prohibition as also applicable to cereal-based foods and other foods intended for infants and children as well as follow-on foods.
However, the interpretations provided by the national authorities of the individual member states differed somewhat. For example, both France and Germany had promoted a less restrictive reading of art. 27 of Reg. 889/2008 with the consequence that organic certification of the products in question was possible in these countries.
The different interpretations resulted, in practice, in important discrimination within the single market, given the profitability of organic products. In light of this situation, a specific question had been posed by the trade associations to Mipaaf which, with a note dated 9/1/2018, had reaffirmed its position, based on the answers obtained from the Ministry of Health. The latter, consulted, had pronounced as follows on 5 October 2017: "... regarding your request relating to the subject and reported in the email at the bottom, on the basis of the opinion expressed by the European Commission through DG AGRI, having also having consulted DG SANTE, it is noted that organic certification is not considered possible for infant formulas and follow-on formulas pursuant to Dir. 2006/141, as well as for foods intended for infants under Dir. 2006/125 to which they are added vitamins and minerals of non-agricultural origin ....... " Only later was there a change of orientation by the Ministry of Health, which with the note Protocol n. 0046892 of 22/06/2018, addressed to the PQAI I Organic Agriculture and National Food Quality Systems and Mipaaf General Affairs Office, clarified that the content of the "Judgment of the European Court of Justice of 201423 relating to the prohibition of adding mineral salts and vitamins to organic foods, should not be considered applicable to infant formulas, follow-on formulas, processed cereal-based foods and other baby foods (excluding growth milks) ". Consequently, the internal interpretation of art. 27 has changed significantly.

The new organic regulation has introduced changes on the issue, which coherent with the interpretation currently promoted by both the Ministry of Health and the Mipaaf.
In particular, art. 16, par 1, of Reg. 848/2018 in defining the requirements to be met for the production of a processed organic food, refers in full to the provisions of Annex II - part IV. In this section, paragraph 2.2 relating to the use of certain products and substances in food processing is highlighted, for which the substances that can be used are expressly listed in paragraph 2.2.2 below, among which letter f) indicates: "F) mineral substances (including trace elements), vitamins, amino acids and micronutrients, provided that: i) their use in foods for normal consumption is" directly provided for by law ", that is, directly provided for by provisions of the law of Union or by provisions of national law compatible with Union law, with the consequence that food cannot be placed on the market as food for normal consumption if these minerals, vitamins, amino acids or micronutrients have not been added; or ii) with regard to foods placed on the market as foods with particular characteristics or effects in relation to health or nutrition or in relation to the needs of specific groups of consumers:
- in the products referred to in Article 1, paragraph 1, letters a) and b), of Regulation (EU) no. 609/2013 of the European Parliament and of the Council (1), their use is authorized by that regulation and by the acts adopted on the basis of its Article 11 (1) for the products in question, or
- in products regulated by Commission Directive 2006/125 / EC (2), their use is authorized by that directive ".
In the case in question, the interest falls on point f) highlighted, with particular reference to the first under point ii), in which the addition of vitamins and mineral salts is substantially allowed for organic products that meet the definition of "formula for infants and follow-on formula "24, as well as for those identified as" food based on cereals and other food for early childhood "25 in compliance with the provisions of art. 11 par. 1 of Regulation 609/2011 and finally, for foods governed by dir. 2006/125 / EC.

This addition, rather than constituting an opening of the organic production system to the use of vitamins and mineral salts, is a confirmation of an interpretation already widespread among food sector operators, as the main novelty of the modification in question is given by the introduction of a positive list of admitted cases. However, even in this case “growth milks” must be considered excluded26.
Although the definition of "early childhood child" coincides with the recipients of growth milk, ie children aged between 1 and 3 years, the definition of food for early childhood contained in art. 2, par. 2, lett. f) of Regulation 609 of 2013 expressly excludes "milk-based drinks and similar products intended for infants"27
In this regard, it is concluded that the possibility of adding vitamins and mineral salts to growth milk, once Regulation 848/2018 is applicable (i.e. from 1 January 2021), is quite unlikely and could only be justified by a particularly reading restrictive of the concept of "drink based on milk or similar products", such as to exclude growth milk from the category just described - a bold interpretation to say the least.
In confirmation of the interpretative reading just proposed, the last note issued by Mipaaf of July 2018 is reported28which revokes the previous note of January 2018 on the basis of the position adopted by the Ministry of Health in June 2018, and therefore establishing once and for all that the products ex dir. CE / 2006/141 and ex dir. CE / 2006/125 are certifiable as organic despite the addition of vitamins and mineral salts. Also in this case it is specified that growth milks must be excluded from these considerations.

It should also be added that the European Commission has adopted an implementing regulation amending regulation 889/2008 (which contains the methods of application of regulation 834/2007), with the aim of avoiding a discrepancy between the wording of art. . 27 par. 1 letter f) and the new organic legislation substantially anticipating the entry into force of Regulation 848/2018 as regards the matter in question. Therefore, pursuant to art. 1, no. 3) of the Implementing Regulation 1584/2018, letter f) of article 27, paragraph 1 of Regulation 889/2008 is amended as follows "" f) mineral substances (including trace elements), vitamins, amino acids and micronutrients, a provided that:
i) their use in foods for normal consumption is "directly provided for by law", i.e. directly provided for by provisions of Union law or by provisions of national law compatible with Union law, with the consequence that the foods can be placed on the market as food for normal consumption if these minerals, vitamins, amino acids or micronutrients have not been added; or (ii) with regard to food placed on the market as food having particular characteristics or effects in relation to health or nutrition or in relation to the needs of specific groups of consumers: - in the products referred to in Article 1 (1) , letters a) and b), of Regulation (EU) no. 609/2013 of the European Parliament and of the Council (*), their use is authorized by that regulation and by the acts adopted on the basis of its Article 11 (1) for the products in question, or
—In products covered by Commission Directive 2006/125 / EC (**), their use is authorized by that Directive, or
—In products covered by Commission Directive 2006/141 / EC (***), their use is authorized by that Directive

This modification, as already pointed out, does not involve any novelty as regards the growth milk, as it is not included in any of the categories listed, however it should be noted that, as well as being expressly allowed for products ex dir. 2006/125 / EC and ex dir. 2006/141 / EC is allowed for all infant formulas and follow-on formulas, for cereal-based foods and for all foods intended for infants if their use is authorized by Reg. 609/2013 or by deeds delegates of the same. The choice not to allow organic certification of growth milks, despite the fact that they are products intended for specific categories of consumers and having characteristics similar to those of other products that can be certified organic, seems somewhat unjustified from a regulatory point of view, since it shows a willing to build an exception around growth milk.
However, the Commission's choice was probably dictated by the scientific opinion of the European Food Safety Authority (EFSA) on growth milks. In October 2013, the European Agency specified that growth milks are used to promote the intake by infants of young children of nutrients such as n-3 polyunsaturated fatty acids, iron and vitamin D, whose assimilation is likely to be insufficient for some of the little ones. Growth milks, however, according to EFSA, are not the only tool that can be used for this purpose: the same result can be achieved with the use of enriched cow's milk29, with the intake of cereals or enriched cereal-based foods, supplements or even the early introduction of meat and fish into the child's diet. In conclusion, EFSA believes that growth milks do not play a unique and indispensable role in the diet of young children and consequently are not considered necessary to meet the nutritional needs of children.
However, the consequence of this regulatory gap, caused by political-scientific reasons, is to discourage the use of organic milk for the production of these products, since it is not possible for the producer to certify growth milks as "organic products”, He will certainly have no interest in using organic milk to make them. In fact, it would not be convenient at all to use organic milk since it could only indicate the presence of this ingredient on the label without being able to define the product itself as organic.

From the example just illustrated it can be clearly deduced how the previous formulation of Regulations 834/2007 and 889/2008 had created ambiguities due to the lack of precision in the definition of some legislative cases, thus giving rise to different interpretations in the individual member states which resulted in cases of unfair competition within the single market. The need for a uniform vision has therefore led the European legislator to reformulate the provisions in question, adding a positive list of cases in which the addition of vitamins and minerals is allowed. As evidence of the concrete need to resolve interpretative disputes, it should be noted that the Commission intended to anticipate the effects of the new regulation with the adoption of reg. 1584/2018 which amended regulation 889/2008 which was applied as early as October 2018, unlike regulation 848/2018 which will apply from January 2021.


As already highlighted in relation to the example just reported, the new organic regulation was adopted with the aim of reducing the interpretative differences in the individual member states and therefore stemming the consequent phenomena of alternation of competition that occurred in the internal market. The intention to move more and more towards a complete harmonization of the discipline is clear, however, the European legislator must continually measure itself first of all with the technical adjustment time necessary for all operators in the sector, and secondly with the practical consequences that such changes entail in the consumer’s perception, as well as having to assess the environmental, atmospheric and climatic conditions in which farmers operate. In the practical case described above, the regulatory gap clearly created an interpretative problem which in turn gave rise to a problem of distorted competition on the internal market, but some regulatory differences could arise from specific needs worthy of protection.

At this point, therefore, the question arises whether granting individual member states the possibility of maintaining disciplines that are partially different from each other in the field of organic certification, cannot be a choice justified by the intent to disseminate the organic farming method itself.

In fact, it should be remembered that, beyond any economic implications related to the organic market, the organic discipline is clearly based on respect for the environment and the promotion of sustainable agricultural techniques.

Consequently, the question arises whether, in the name of the intention to spread the values ​​of organic farming, it is not appropriate to grant some exceptions in such a way as to encourage, even if only partially, the sharing of an agricultural system that is more respectful of the environment.

On the other hand, however, the adoption of any exceptions must not result in a penalization and distortion of the organic system itself, shifting the consequences of the current regulatory fragmentation both on consumers who will have to be satisfied with a less restrictive organic, both on countries that adopt a more virtuous biological discipline, penalizing them in terms of distorted competition. In other words, should the protection of the internal market or the promotion of the underlying objectives of organic farming prevail?
The direction that the European legislator intends to embrace is still not clear. Surely the practical impact of the new organic regulation can be assessed only after the rule is applied throughout the territory of the Union, and especially after the issuing of the delegated acts that the Commission will adopt on the basis of art. 290 TFEU as well as the acts that it will adopt to implement the regulation in question (such as the report that will be prepared in 2026 on the derogation for cultivation in boxes as per recital 30). Of particular importance in this regard will be the strategy that the Commission will adopt regarding the possibility of requesting common rules on contamination thresholds.

Ultimately, it is clarified that this paper is not intended to give an answer to such an important question, rather it is intended to provide food for thought to then observe and analyze the consequences of the application of the new regulation 848/2018.

Bologna - May 16, 2020

Avvocato Silvia Guidi – Studio Legale de Capoa e Associati – Bologna –

1 Implementing Regulation No. 1584/2018 amending Regulation (EC) No. 889/2008 laying down methods of application of Regulation (EC) no. 834/2007 of the Council on organic production and labeling of organic products, as regards organic production, labeling and controls.

2 Mario Mauro "The new regulation on organic agriculture: new perspectives and old paradigms" in Agricultural, Food and Environmental Law and Jurisprudence, n. 6/2018.

3 Art 43 TFEU: "The Commission presents proposals for the development and implementation of the common agricultural policy, including the replacement of national organizations by one of the forms of common organization provided for in Article 40, paragraph 1, as well as the implementation of the measures specified in this title. Such proposals must take into account the interdependence of the agricultural issues mentioned in this title. 2. The European Parliament and the Council, acting in accordance with the ordinary legislative procedure and after consulting the Economic and Social Committee, shall establish the common organization of the agricultural markets referred to in Article 40 (1) and other provisions necessary for the pursuit of the objectives of the common agricultural and fisheries policy. C 326/64 EN Official Journal of the European Union 26.10.2012 3. The Council, on a proposal from the Commission, shall adopt measures relating to the fixing of prices, levies, aids and quantitative limitations, as well as the fixing and sharing of possibilities fishing. 4. The common organization provided for in Article 40 (1) may be substituted for national market organizations, under the conditions provided for in paragraph 2: same of a national organization for production in question equivalent guarantees for the employment and standard of living of the producers concerned, having regard to the pace of possible adaptations and necessary specializations; and (b) when such an organization ensures conditions for trade within the Union similar to those existing on a national market. 5. Where a common organization is created for certain raw materials and there is not yet a common organization for the corresponding processed products, the raw materials in question used for processed products intended for export to third countries, they can be imported from outside the Union ".

4 Costato Manual

5 Cons. 1 of Reg. 2092/91 “whereas these products are sold on the market at a higher price, while the production method requires a less intensive use of land; whereas this method of production can therefore play a role in the reorientation of the common agricultural policy as regards achieving a better balance between supply and demand for agricultural products, environmental protection and conservation of the countryside ' in M. Mauro, op. cit.

6 In particular, the Regulation 178/2002 of the European Parliament and of the Council of 28 January 2002 which establishes the general principles and requirements of food law, establishes the European Food Safety Authority and establishes procedures in the field of food safety. In fact, it should be remembered that following the health emergency caused by the spread of Bovine Spongiform Encephalopathy (mad cow), the European Community has decided to promote a new food safety system, based on a transversal approach to all food products that guaranteed their traceability and a high level of public health protection.

7 Cons. 1 Reg. 834/2007 "Organic production is a global system of farm management and agri-food production based on the interaction between best environmental practices, a high level of biodiversity, the protection of natural resources, the application of strict animal welfare criteria and production suited to the preferences of certain consumers for products obtained from natural substances and processes. The organic production method therefore performs a dual social function, providing on the one hand a specific market that responds to consumer demand for organic products and, on the other, providing public goods that contribute to environmental protection and animal welfare. and rural development ".

8 Consider that the legal basis of Reg. 834/2007 is art. 114 TFEU, or the rule relating to the approximation of the national legislations of the individual member states, from this we can easily deduce the rationale of the European legislator.

9 Organic products are partly different in size, color and flavor from traditional ones and are characterized by a certain variability of some organic compounds.

10 For example, recital no. 104 of this regulation states that member states are required to periodically update the lists of control authorities.

11 Francesca De Cristofaro "Approved the new EU regulation on organic agriculture, here are the most important news" accessible at:

12 Furthermore, it should be considered that the various bilateral international agreements between the European Union and various non-EU countries will still remain in force, therefore, most of the European export rules will remain unchanged.

13 Regulation 2018/848, News on organic controls and certifications. But also export, import, entry into force and application accessible at: also-export-import-entry-into-force-and-application/

14 Roberto Setti (Head of the CCPB Technical and Quality Assurance Office) "Pills from the new organic regulation: group certification" accessible at: 5/

15 In Annex II, Part I of Reg. 848/2018 it is reiterated that cultivations that live soil, or on live soil mixed or fertilized with materials and products allowed in organic production, in association with the subsoil and rocky substrate are prohibited, unless they are crops that naturally grow in water. Hydroponic production is expressly forbidden but strangely not aeroponic production (which, however, must be considered equally prohibited), various exceptions are then introduced: the production of sprouts from moistened seeds and the obtaining of chicory heads, also by immersion in such water, are allowed. which, pot cultivation of vegetables for the production of ornamental plants and aromatic herbs sold in pots to the final consumer and the cultivation of seedlings or transplant plants in containers for subsequent transplantation.

16 Recital 24 expressly invites operators to: "proportionate precautionary measures under their control, in order to avoid contamination by products or substances not authorized for use in organic production in accordance with this Regulation and to avoid mixing of products organic, in-conversion and non-organic ".

17 BOrganic - New EU regulation - FedCooperative Fedagri Circular, Prot. N. 3095 / FL / is, Rome 25/06/2018

18 Report from the Commission to the European Parliament and the Council on infant formulas {SWD (2016) 99 final}

19 Art. 2 par. 2 Reg. 609/2013: "2. It also means:
a) "infant" means a child under 12 months of age;
b) "infant child" means a child between one and three years of age;
c) "formula for infants": a food product intended for feeding infants in the first months of life, capable of satisfying the nutritional needs of infants on its own up to the introduction of adequate complementary nutrition;
d) "follow-on formula": a food product intended for the feeding of infants when an adequate complementary diet is introduced and which constitutes the main liquid element in the context of a progressively diversified diet of such infants;
e) "cereal-based food" means a food product:
simple cereals reconstituted or to be reconstituted with milk or other appropriate nutritional liquid,
cereals with the addition of a protein-rich food, reconstituted or to be reconstituted with water or other liquids not containing proteins,
pasta to be used after cooking in boiling water or other suitable liquids,
biscuits and rusks to be used as they are or after being crumbled and combined with water, milk or other suitable liquids;
f) 'baby food' means a food product intended to meet the specific needs of healthy infants during weaning and healthy infants to supplement their diets and / or gradually accustom them to a ordinary nutrition, with the exception of: g) "food for special medical purposes": a food product expressly prepared or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; is intended for the complete or partial nutrition of patients with limited, disturbed or impaired ability to take, digest, absorb, metabolize or eliminate common foods or certain nutrients contained in them or metabolites, or with other nutritional needs determined by clinical conditions and whose dietary management cannot be carried out solely by modifying the normal diet; h) "substitute for the entire daily diet for weight control": a food product expressly formulated to be used in the context of low-calorie diets aimed at reducing weight which, if used according to the instructions of the food business operator, replaces the entire daily food ration ".

20 Commission Regulation (EC) No. 889/2008 of 5 September 2008 laying down detailed rules for the application of Regulation (EC) No. 834/2007 of the Council on organic production and labeling of organic products, as regards organic production, labeling and controls

21 Article 27 - Use of certain products and substances in food processing 1. For the purposes of Article 19 (2) (b) of Regulation (EC) no. 834/2007, only the following substances may be used in the processing of organic food, with the exception of wine: a) the substances listed in Annex VIII of this Regulation; b) preparations based on microorganisms and enzymes normally used in food processing; c) substances and products defined in Article 1 (2) (b) (i) and in Article 1 (2) (c) of Council Directive 88/388 / EEC and labeled as natural flavoring substances o natural flavoring preparations in accordance with Article 9 (1) (d) and Article 9 (2) of the same Directive; (d) the dyes used for the marking of meat and egg shells in accordance with Article 2 (8) and (9) of Directive 94/36 / EC of the European Parliament and of the Council; e) drinking water and salts (with sodium or potassium chloride as a basic component) usually used in food processing; f) mineral substances (including trace elements), vitamins, amino acids and other micronutrients, authorized only if their use is required by law in the foods in which they are incorporated.

22 Judgment C-137/13 of 5 November 2014.

23 This ruling sanctioned the prohibition of certifying as organic foods governed by dir. 2009/39 / EC and by Reg. 953/2009 if added with vitamins and mineral salts

24 Article 1, paragraph 1, letters a) of Regulation 609/2013.

25 Article 1, paragraph 1, letters b) of Regulation 609/2013.

26 Please note that before the entry into force of Regulation 609/2013, some European States considered growth milks to fall within the discipline of dir. 2009/39 / EC relating to foods intended for particular diets (ie dietary products). In fact, this directive did not contain a positive listing of what were dietetic foods, consequently the interpretation was left to the individual member states. Now, however, with the new formulation of art. 2 par. 2 lett. f) the European legislator has dispelled all doubts, expressly excluding milk-based beverages among foods intended for young children.

27 Art. Par. 2 Reg. 609/13 "f)" food for early childhood ": a food product intended to meet the specific needs of infants in good health during the weaning period and of infants in good health to supplement their diet and / o to gradually accustom them to an ordinary diet, with the exception of: i) cereal-based foods; and (ii) milk-based drinks and similar products intended for young children; "

28 DG PQAI - PQAI 01 - Prot. Output N.0053423 of 07/19/2018.

29 It is milk enriched with vitamins and mineral salts intended for use by any consumer and therefore differs from growth milks because it does not contain other specific substances that characterize the composition of products intended for children.

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