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calendar_today 30 May 2023
On May 30, 2018, the European Parliament and the Council of the European Union adopted Regulation 848 of 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No. 834/2007, the application of which is postponed until January 1, 2021.
The new rules on organic production, in addition to repealing the previous Regulation of the European Parliament and the European Council 834 / 2007, created the need to amend Regulation 889 /2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products, with regard to organic production, labelling and controls, which has therefore been supplemented with the provisions of Implementing Regulation No 1584/20181. The will 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 è gone from being a niche sector, to constituting a viable and accessible alternative for the consumer, compared to the market for conventional products. It is precisely the sharp increase in demand for organic products that has highlighted the need to adopt more uniform regulations across all European Union states. For this reason, after a good 4 years of discussions and comparisons (the proposed revision of the organic discipline dates back to March 2014), è the text in question was adopted, which, however, contains many of the derogations already present in the regulation currently in application, which però it is hoped; will be gradually abandoned. The difficulty of finding a balance between the needs for harmonization of European discipline 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 European Union law. This’translates structurally into the’questioning of the willingness and desirability of individual member states to give up part of their sovereignty in favor of a third body (the’Union), in the’moremore pragmatic realm of technical regulation 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 individual member states to be assessed on a sector-by-sector basis.
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 been noted, both from the perspective of food safety, the protection of quality certifications, the regulation of organic discipline, and other aspects. With particular reference to the’last case, with this paper, after a brief historical excursus, we intend to briefly go over some of the main novelties of the new organic discipline. Through the analysis of a practical case, a reflection is proposed on what interests are at stake in the regulation of organic production that the European legislator must balance. Historical Excursus on the concept of organic farming
The concept of organic farming originates, in theoretical terms, 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 the small and medium-sized farmers felt the need to adopt an alternative system, aimed at increasing the productivity of farmland while ensuring respect for the environment: in response to these instances Steiner ideò the method of biodynamic agriculture. Based primarily on the three golden principles of maintaining the fertility of the soil, increasing the ability of plants to resist disease and pests, and producing healthy, quality food;, the biodynamic philosophy has given rise to an alternative way of carrying out agricultural activity that, while coinciding in many respects with organic production, differs from it in greater rigor and 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 ensuring respect for nature, the former can be defined as a method of cultivation (or from the market point of view, a system certification), the latter, on the other hand, constitutes a true way of life.
From the biodynamic school, therefore, originates the organic method, which in the passage of time has acquired more and more autonomy delineating its own identity in a gradually more precise way. In fact, around the early 1970s several small and medium-sized farmers began to join together in organized groups that later formed sector associations in order to formulate their own specifications inspired by organic principles. Faced with such a varied and fragmented reality consisting of a multitude of small sector associations each with its own specifications, the need arose to give uniformity to the organic matter. To this end, the International Federation of Organic Agriculture Movements (IFOAM) was formed, which adopted the «Standards of Organic Agriculture for International and Domestic Trade» in 1982. The work of IFOAM constituted the starting point from which the European legislature, in the early 1990s, took its cue to outline the first European organic regulations2. For the first time in the European context, EEC Regulation 2092/91 conferì legal value on the concept of organic farming, beginning a process of regulating it.
It‘s important to note that the legal basis of Regulation 2092/91 was Article 43 of the TFEU3 so its adoption was totally ascribable to the group of regulatory instruments used by the European Commission within the framework of the Common Agricultural Policy (CAP)4 . It is no coincidence that the European legislator grants attention and protection to the demands of the autonomous movements of organic farmers, precisely at a time when CAP strategies had created a’surplus of agricultural products on the market. As a result, the prices of agricultural products had fallen, creating the need to adopt forced-purchase policies in order to provide stability to the market and ensure a decent income for farmers. Organic products, being the result of less intensive and less profitable cultivation techniques, were priced higher than competing conventional products, which is why, with recital 1 of this regulation, the European legislator also recognized the promotion and regulation of organic farming as a "reorientation of the common agricultural policy with regard to achieving a better balance between the supply and demand for agricultural products"5 The first regulation on organic farming presented itself from the outset as an extremely fragmented system because of the many corrections and additions that have been made over the years (about 70 amendments). This legislation was also ineffective in the face of the need to regulate, in an increasingly stringent manner, a growing market such as the organic market, which had, among other things, to relate to the important innovations introduced by the European Community in the field of food safety6.
For these reasons, in 2007, the European legislator adopted Council Regulation 834 / 2007 of June 28, 2007 on organic production and labeling of organic products and repealing Regulation (EEC) No 2092/91, which in addition to extending the scope of the organic regulations to seaweed plant production, animal production and aquaculture, marked a major reversal in the relationship between organic agriculture and the internal market. If in fact, before, the organic sector was interpreted as a support tool for the CAP, in 2007 more prominence was given to the objectives proper to the organic philosophy. In fact, some of the recitals of the regulation mention 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 preservation of natural resources7. In addition, the’introduction a more coordinated and uniform regulatory system has facilitated the functioning of the internal market, as well as reduced the phenomena of unfair competition and obstacles placed on intra-EU trade8. The organic discipline applies to both primary and processed products. In the latter case, however, è it is necessary that at least 95 percent of products of agricultural origin be organic. The control system for organic products è constituted on a national basis, each member state designating the competent authority for certifications, which in Italy è the Ministry of Agricultural Food and Forestry Policies (MiPAAF), which in turn manages the individual control bodies dependent on it.
Each inspection body, which must be third-party and independent, è identified by an alphanumeric code that must appear on the ’food label along with the organic logo and the words “bio”. Specific rules on the labeling of organic products are contained in Regulation 889/2008. Organic certification è a process certification, as it aims to ensure that producers have adopted a certain production method in carrying out their agricultural activity, no assurance è however, given regarding the characteristics of the final product. In other words, organic certification does not aim to differentiate organic food from conventional food by attesting to a difference on the 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, in the view of the consumer, conventional products will very often present themselves as more aesthetically homogeneous9 and more similar in taste than their organic counterparts, however, these observations are not supported by scientific basis.
The new Regulation 848 /2018 is introduced into an already fairly structured and defined regulatory framework, proposing to improve this system in order to increase consumer confidence in the organic market, through more transparent certification and control mechanisms that will result in an increase in the 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 CAP 2014-2020, 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 January 1, 2021, is presented as a regulatory intervention aimed at introducing important changes, again in the sense of making the discipline even more harmonized. In this regard, a number of novelties should be noted, which will be analyzed in brief below: the modification of the import-export regime, the introduction of group certifications, the change in the periodicity of controls, the prohibition of out-of-soil cultivation with the related derogation for some northern European countries (Denmark, Sweden and Finland), as well as the introduction of a different approach regarding the thresholds of accidental contamination.
The regulations currently in force, namely Regulation 834 /2007, established the principle of equivalence between organic products made in the European Union and those from third countries, with the result that products recognized as organic outside the Union can circulate in the internal market with the status of organic products, regardless of the content of the organic farming regulations in force in the state of origin. In other words, a product that validly can’be certified as organic in a third state can’circulate and be sold in the European territory as an organic product, even if that country’s regulations on the matter are less restrictive than the European one: two products that are both organic, coming from a member state and a third country are considered equivalent.
This legislative choice implies a clear insidiousness, namely: a serious risk of prejudicing European organic producers who are subject to much more stringent regulations than those of many other third states. In this regard, the new Regulation has introduced the principle of conformà11 in place of the principle of equivalence, whereby products to be imported into the internal market must necessarily conform to European standards passed the period of the transitional regime, with the exception of products from countries with which the European Union has a bilateral trade agreement. The’adoption of the conformity principle; è is, therefore, a crucial innovation, although its scope will be more clearly perceptible only after the conclusion of the transitional period12.
Small and medium-sized agricultural enterprises are currently neither able to meet the expenses required to obtain organic certification nor are they able to set up an’administrative organization such that they would be eligible for certification. In order to promote the organic market even among smaller farms, the new European framework has introduced the possibility of applying for collective certification for groups of farmers who meet certain requirements13: geographic proximity of operators and thus proximity of land, as well as a common marketing system for organic products obtained by all members of the group, and again an annual turnover of organic production not exceeding 25,000 euros or in any case a production standard not exceeding 15,000 euros.
For mere completeness of exposition, it should be pointed out that the group certification system è was devised by IFOAM, even before the European Union formulated any kind of regulations on organic farming, however it was an entirely private system14.
The new regulation introduces a facilitated inspection system for those food business operators (FBOs) whose products in the previous three years have been found to meet all the standards of the organic discipline in each annual inspection: with the consequent benefit that the same products will be inspected every biennium instead of being inspected annually. For the rest of the operators, the annual inspections remained fixed, which will be in addition to those generally required for all food products by the new Official Control Regulation No. 625 /2017.
With regard, on the other hand, to the exception to the obligation to cultivate on the ground, granted by’Annex II par.1.5 of the regulation in question, which expressly provides for the possibility of cultivating in demarcated beds only for areas certified as organic in some member states, it cannot be denied that this exception hinders the realization of a discipline on organic farming that is increasingly uniform. The connection between product and soil è considered one of the pillars of organic farming, however, due to a lack of regulation in this regard, several states in’s;Northern Europe have been certifying products made with cultures in demarcated beds as organic for years, and the new organic regulation has granted these countries (Finland, Sweden and Denmark) an extension period of an additional 10 years, only with regard to areas certified as organic for the purpose of this practice before June 28, 2017, so no extension of these areas is allowed15.
Another issue that is a source of discussion è the decision of the European legislature to adopt a not-so-bold solution regarding the issue of thresholds for the presence of chemicals not authorized by organic farming in the case of accidental contamination16. In fact, one of the most critical aspects relates to the fact that no European maximum threshold of chemical agents allowed in organic products is established, and therefore, individual member states remain free to adopt their autonomous contamination thresholds with internal regulations as long asé such measures do not prove to be an obstacle in the movement of goods.
Although, therefore, the approach introduced is aimed at making the subject of contamination more uniform, to date a fully harmonized result has not been achieved. Indeed, the legislature has recalled numerous actions that the organic producer must put in place in order to minimize cases of contamination of organic products, such as taking measures to assess risks and updating these measures periodically.
However, European countries that set very stringent thresholds (such as, for example, Italy) end up being penalized by the lack of European legislation on the point. Under’art. 28, par. 3 è the Commission is given the power to formulate implementing acts aimed at establishing uniform rules on the anti-contamination measures of the various states. In any case, this is not a final choice17: four years after the implementation of this Regulation, the European Commission will evaluate the effectiveness of the provisions on contamination, the various regulations adopted by individual member states and possibly promote the introduction of a fully harmonized system.
The regulations on organic farming (both the one currently in force and the new Regulations) allow only those products to be labeled as “organic” which faithfully adhere to the methods of production specified in the regulations (absence of chemicals in the making of the product, absence of pesticides, for processed products when at least 95 percent of the agricultural ingredients of the product by weight are organic).
Both regulations stipulate that the’addition of vitamins and minerals to organic products is only possible in certain limited cases when this is expressly allowed by law. Here we will analyze the possibility of adding vitamins and minerals while still maintaining the certification of organic food to specific products, the so-called “growth milks” as well as to other foods intended for consumption by children. The current regulations, namely Regulation 834 / 2007 in conjunction with Regulation 889 /2008, will be compared with the new regulations introduced by Regulation 848 /2018 and anticipated in some respects by Regulation 1584 / 2018. Growth milks (or formulas for babies in early childhood) are part of the broader category of foods intended for the consumption of toddlers, although unlike all the rest of the products that constitute the soì so-called “baby food”, they have never been regulated by the European legislator.
However, early childhood baby formulas “can be described as specifically processed/formulated protein drinks intended to meet the nutritional needs of children aged 1 to 3 years”18 . Since these are not expressly regulated products, their energy content and composition are variable, although in most cases the main source of protein è is cow's milk, although generally the protein content of growth milks is lower than that of traditional milk. Manufacturers often find it advisable to keep the level of protein content within the limits allowed by legislation for infant and follow-on formulas set out in Directive 2006/141/EC (which will remain applicable until February 21, 2021 only with regard to infant formulas and follow-on formulas based on protein hydrolysates). Formulas for infants in early childhood are fortified with certain micronutrients (e.g., iron and vitamin D) and polyunsaturated fatty acids, may contain various sugars, sometimes honey, and in some cases flavorings normally found in infant and follow-on formulas, as well as other substances that are allowed in infant or follow-on formulas but are absent in cow's milk.
At this point it will be necessary to provide some clarifications on the legal definitions that come into play in the present case. They are defined as:
In the former wording of Reg. 889 / 200820, Article 2721(1), implementing Art. 19(2)(b) of Reg. 834 /2008,20 was the first paragraph of Article 2721. (b) of Regulation 834 /2007, specified the conditions for the use of particular substances in processed products, regulating, among many others, also added vitamins and minerals that could be used in organic production “only if their use è provided for by law in the foods in which they are incorporated”.
The wording of the article just quoted remained quite general and the meaning to be given to it was left to the interpretation the interpreter intended to give it. While in the case of growing milks, since there were no regulations 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 interpretive issues have arisen, in fact, with regard to other baby food products, that is, for infant formulas or follow-on formulas for which there is ex EC Directive 2006/141 a legal obligation to add vitamins and minerals imposed in an indirect manner, as well as for processed cereal-based foods and other foods for early childhood ex dir. EC 2006/125 for which, equally in an indirect manner, è provided by the same rule the addition of certain vitamins and minerals. In fact, since Art. 27 of Regulation 889 / 2008 did not contain a clear listing in a positive sense of the cases in which the organic product could be added vitamins and minerals, this provision lent itself to the different interpretations of individual member states. In particular, Italy had adopted a restrictive interpretation of this article, which, therefore, prohibited organic certification of added foods unless a specific rule of domestic or European law expressly defined the addition as mandatory. This interpretation was based on what the European Court of Justice had ruled in 2014, which specified: “Article 27(1)(f) of Commission Regulation (EC) No 889/2008 of September 5, 2008 laying down detailed rules for the implementation of Council Regulation (EC) No. 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and controls, must be interpreted as meaning that the use of a substance covered by this provision è provided for by law only on condition that a rule of Union law or a rule of national law in conformity with the latter directly requires the’addition of the said substance in a foodstuff in order for the latter to be marketed in general. The’use of such a substance is not required by law under the said provision when a foodstuff is marketed as a food supplement bearing nutrition and health claims or as a foodstuff intended for a particular diet, despite the fact that this implies that, in order to comply with the provisions on the’incorporation of substances into foodstuffs that are listed, respectively,
In spite of the fact that no specific mention was made in the reported judgment with respect to foods under dir EC 2006/125 and dir EC/ 2006/ 141, the Ministry of Agriculture (Mipaaf) had interpreted this prohibition as also applying to cereal-based foods and other foods intended for infants and young children as well as follow-on foods. However, the interpretations provided by the national authorities of individual member states were quite differentiated. For example, both France and Germany had promoted a less restrictive reading of Art. 27 of Reg. 889 /2008 with the result that organic certification of the products in question was possible in these countries.
The different interpretations resulted, in practice, in significant 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, in a note dated 9/1/2018, had reiterated its position, based on the answers obtained from the Ministry of Health. The latter, when questioned, had pronounced itself as follows on October 5, 2017: “…Regarding your request related to the subject and reported in the email below, on the basis of the opinion expressed by the European Commission through DG AGRI, having also consulted DG SANTE, it is represented that it is not considered the certification of organic possible for formulas for infants and follow-on ex Dir. 2006/141, as well as for foods for infants in early childhood ex Dir. 2006/125 to which vitamins and minerals of non-agricultural origin…… are added.” It was only later that there was a change of direction by the Ministry of Health, which in a note Protocol no. 0046892 dated 22/06/2018, addressed to the ’ PQAI I Organic Agriculture and National Food Quality Systems and General Affairs Office Mipaaf, clarified that the content of the “European Court of Justice ruling of 201423 regarding the prohibition on the addition of mineral salts and vitamins to organic foods, should not be considered applicable to infant formulas, follow-on formulas, processed cereal-based foods and other infant foods (excluding growth milks)”. As a result, the’internal interpretation of’Article 27 è changed very significantly.
The new organic regulation has introduced changes on the issue, which are in continuity with the’interpretation currently promoted by both the Ministry of Health and Mipaaf. Specifically, the’art. 16, par 1, of Reg. 848 / 2018 in defining what are the requirements to be met for the production of a processed organic food, refers in full to what is established in’Annex II – Part IV. In this section, comes into prominence, paragraph 2.2 on the’use of certain products and substances in food processing, whereby the following sub-section 2.2.2 expressly lists the substances that can be used, among which under (f) are indicated:
“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 Union law or provisions of national law compatible with Union law;Union law, with the result that foods cannot be placed on the market as foods for normal consumption if such minerals, vitamins, amino acids or micronutrients have not been added; or (ii) in respect of foods placed on the market as foods with special characteristics or effects in relation to health or nutrition or in relation to the needs of specific groups of consumers:
In the present case, the interest falls on the highlighted point (f), with particular reference to the first sub-point (ii), where basically the addition of vitamins and minerals is allowed for organic products that meet the definition of “infant formula and follow-on formula”24 as well as for those identified as “cereal-based food and other early childhood food”25 in accordance with the requirements of ’Art. 11(1) of Regulation 609/2011 and finally, for foods regulated by dir. 2006/125/EC. This addition more than constituting an’opening of the organic production system to the’use of vitamins and mineral salts, turns out to be a confirmation of an’interpretation already widespread among food business operators, since the main novelty of the amendment in question è lies in the’introduction of a positive list of permitted cases. They must, however, be considered excluded, again “milk growth”26.
Although the definition of “early childhood child” coincides with the recipients of growth milk, i.e., children between the ages of 1 and 3 years, the definition of early childhood food in Article 2(2)(f) of Regulation 609 of 2013 expressly excludes “milk-based beverages and similar products intended for early childhood children”.27 In this regard, it is concluded that the possibility of adding vitamins and minerals to growth milk, once Regulation 848/2018 is applicable (i.e., from January 1° 2021), è quite unlikely and could only be justified by a particularly restrictive reading of the concept of “beverage based on milk or similar products” such that growth milk – an interpretation that is bold to say the least, is excluded from the category just described.
To confirm the interpretative reading just proposed, we report the latest note issued by Mipaaf in July 201828 that revokes the previous note of January 2018 on the basis of the position adopted by the Ministry of Health in June 2018, and thus establishing once and for all that products ex dir. EC/2006/141 and ex dir. EC/2006/125 are certifiable as organic despite the addition of vitamins and minerals. Again, this specifies that growth milks are to be excluded from these considerations.
It should be added, moreover, that the European Commission has adopted an implementing regulation amending Regulation 889 /2008 (laying down the detailed rules for the implementation of Regulation 834/2007), with the intention of avoiding a discrepancy between the wording of Art. 27 par. 1(f) and the new organic legislation by substantially anticipating the entry into force of Regulation 848/2018 with regard to the matter in question. So, according to the’Art. 1, No. 3) of the Implementing Regulation 1584/2018 the letter f) of’Art. 27, paragraph 1 of Regulation 889 / 2008 is amended as follows “«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 Union law or provisions of national law compatible with Union law;Union law, with the result that foods cannot be placed on the market as foods for normal consumption if such minerals, vitamins, amino acids or micronutrients have not been added; or (ii) in respect of foods placed on the market as foods with special characteristics or effects in relation to health or nutrition or in relation to the needs of specific groups of consumers: —in products referred to in Article 1(1)(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 the acts adopted on the basis of its Article 11(1) for those products, or
This amendment, as already pointed out, does not imply any novelty as far as growth milk is concerned, as it is not included in any of the listed categories, however it should be noted that, organic certification in addition to being expressly allowed for products ex dir. 2006/125/EC and ex dir. 2006/141/EC è allowed for all infant and follow-on formulas, cereal-based foods and all foods intended for infants in early childhood if their use is authorized by Reg. 609/2013 or its delegated acts.
The choice of not allowing organic certification to growth milks, despite the fact that they are products intended for specific categories of consumers and have similar characteristics to those of other products that can instead be certified organic, seems somewhat unjustified from a regulatory point of view, since it seems that the legislator wanted to build an exception precisely 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 pointed out that growth milks are used to promote early childhood children’s intake of nutrients such as n-3 polyunsaturated fatty acids, iron and vitamin D, the assimilation of which is likely to be insufficient for some of the youngest children. Growth milks, per’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 enriched cereals or cereal-based foods, supplements or even the’early introduction of meat and fish into the child's diet. In conclusion, EFSA is of the opinion that growth milks do not play a unique and indispensable role in the diet of early childhood children and consequently cannot be considered as necessary to meet the nutritional needs of children.
However, the consequence of such a regulatory gap, caused by political-scientific reasons, è is to disincentivize the use of organic milk to make such products, since it is not possible for the producer to certify growth milks as “organic” products, the same will certainly have no interest in using organic milk to make them. Indeed, it would not be at all convenient to use organic milk by only being able to 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 seen that the previous wording of Regulations 834/2007 and 889/2008 had created ambiguities due to the lack of precision in the definition of certain regulatory cases, thus giving rise to different interpretations in individual member states that resulted in cases of unfair competition within the single market. The need for a uniform view therefore led the European legislator to reformulate the provisions in question, adding a listing in a positive sense of the 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 that è been applied already since October 2018, unlike Regulation 848 / 2018 that will apply from January 2021.
Così as highlighted already in relation to the example just given, the new discipline on organic è was adopted with the aim of reducing the diversitiesà of interpretation in individual member states and thus curb the consequent phenomena of alternation of competition that have occurred in the internal market. The intent to move increasingly toward full harmonization of the discipline is clear, however, the European legislator must continually measure itself firstly with technical lead times required for all operators in the sector, secondly with the practical consequences that such changes entail in consumer perception, and thirdly, it must assess the environmental, atmospheric and climatic conditions in which farmers operate. In the practical case just presented, the regulatory gap clearly created an interpretive problem that in turn gave rise to a problem of distorted competition in the domestic market, but some regulatory differences could arise from specific needs deserving protection.
At this point, therefore, the question arises as to whether allowing individual member states the option of maintaining partially different disciplines from one another in the area of organic certification might not be a choice justified by the’intent of popularizing the method of organic farming itself.
In fact, at this juncture è it should be remembered that, beyond any economic implications related to the organic market, the organic discipline è is clearly based on respect for the environment and the promotion of sustainable farming techniques. Consequently, the question arises as to whether, in the name of spreading the values of organic farming, some exemptions should not be granted so as to encourage, even partially, the sharing of a more environmentally friendly farming system. On the other hand, for’the’adoption of any derogations should also not result in a penalization and distortion of the organic system itself, shifting the consequences of the’current regulatory fragmentation both to consumers who will have to make do with a less restrictive organic, and to countries that adopt a more virtuous organic 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? Still the’direction that the European legislature intends to embrace is unclear. Certainly the practical impact of the new organic regulation can be assessed only after the rule is applied throughout the Union, and especially also after the issuance of the delegated acts that the Commission adopts on the basis of Art. 290 TFEU as well as the acts that it adopts to implement this regulation (such as the report that will be prepared in 2026 on the subject of the derogation for box cultivation as per Recital No. 30). Of particular importance in this regard will be the strategy that the Commission adopts regarding the possibility of requiring a common framework for contamination thresholds.
In the end, it is clarified that this paper is not intended to provide an answer to such an important issue, rather it is intended to provide food for thought in light of which to observe and analyze the consequences of the’application of the new Regulation 848/2018.
1 Implementing Regulation No. 1584/2018 amending Regulation (EC) No. 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No. 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and controls.
2 Mario Mauro “The new regulation on organic farming: new perspectives and old paradigms” in Food and Environmental Agricultural Law and Jurisprudence, No. 6/2018.
3 Article 43 TFEU: “The Commission shall submit proposals concerning 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(1), as well as the implementation of the measures specified in this title. These 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 agricultural markets provided for in Article 40(1) and such other provisions as are necessary to achieve the objectives of the common agricultural and fisheries policies. 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 on the fixing of prices, levies, aid and quantitative limitations, and the fixing and allocation of fishing opportunities. 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: (a) where the common organization offers Member States which oppose the decision and have themselves a national organization for the 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 the necessary specializations; and (b) where such an organization ensures conditions for trade within the Union similar to those existing in a national market. 5. Where a common organization is established for certain raw materials without there yet being a common organization for the corresponding processing products, the raw materials in question, used for processing products intended for export to third countries, may be imported from outside the Union'
4 Cost Manual
5 Cons. 1 of Reg. 2092 / 91 «whereas these products are sold on the market at a higher price, while the method of production requires less intensive use of land; that this method of production can therefore play a role in the reorientation of the common agricultural policy with regard to achieving a better balance between supply and demand for agricultural products, the protection of the environment and the preservation of rural space» in M. Mauro, op. cit.
6 In particular, an important impact on the pre-existing European food regulations was Regulation 178/2002 of the European Parliament and of the Council of January 28, 2002, which lays down 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 is recalled that as a result of the health emergency caused by the spread of Bovine Spongiform Encephalopathy (mad cow disease), the European Community decided to promote a new food safety system, based on a cross-cutting approach to all food products that would ensure their traceability and a high level of public health protection.
7 Cons. 1 Reg. 834/2007 “Organic production è an overall system of farm management and agri-food production based on the’interaction between the best environmental practices, a high level of biodiversity, the preservation of natural resources, the’application of strict animal welfare criteria, and production that is suited to the preferences of certain consumers for products obtained with natural substances and processes. Thus, the organic production method performs a dual social function, providing for a specific market that meets consumer demand for organic products on the one hand and, on the other, providing public goods that contribute to environmental protection, animal welfare and rural development”.
8 Consider that the legal basis of Reg. 834 / 2007 is the’art. 114 TFEU, i.e., the rule on the approximation of national laws of individual member states, from this one can’easily infer the rationale of the European legislator.
9 Organic products are partly different in size, color and taste from traditional ones and are characterized by a certain variability of certain organic compounds.
10 For example, recital 104 of this regulation states that member states are required to periodically update the lists of inspection authorities.
11 Francesca De Cristofaro “Approved the new EU Regulation on organic farming, here are the most important”changes” accessible at: https://www.magevola.it/impresa/food-e-agricoltura/nazionale/regolamento-agricoltura-biologica/.
12 Consider also 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: https://www.macchinealimentari.it/2019/12/17/regolamento-2018-848-novita-su-controlli-e-certificazioni-bio-ma-anche-export-import-entrata-in-vigore-e-applicazione/
14 Roberto Setti (Technical and Quality Assurance Office Manager; CCPB) “Pills from the new organic regulation: group certification” accessible at: www.ccpb.it/blog/2019/06/11/pillole-dal-nuovo-regolamento-bio-5/
15 In ’Annex II, Part I of Reg. 848/2018 è it is reiterated that cultivation that live soil, or on live soil mixed or fertilized with materials and products allowed in organic production, in association with subsoil and rocky substrate is prohibited, unless it is crops growing naturally in water. Hydroponic production is expressly forbidden but strangely not aeroponic production (which però must be considered equally forbidden), various exceptions are then introduced: è production of sprouts from moistened seeds and obtaining chicory heads, including by immersion in water as is, pot cultivation of vegetables for the production of ornamental plants and herbs sold in pots to the final consumer, and cultivation in containers of seedlings or plants for transplanting later.
16 Recital 24 expressly calls on operators to: “proportionate precautionary measures under their control to avoid contamination by products or substances not authorized for use in organic production in accordance with this Regulation and to avoid the admixture of organic, in-conversion and non-organic products”.
17 Organic – New EU Regulation – FedCooperative Fedagri Circular, Prot. no. 3095/FL/is, Rome 25/06/2018
18 Report from the Commission to the European Parliament and the Council on infant formulae in early childhood {SWD(2016) 99 final}
19 Art. 2 para. 2 Reg. 609 / 2013: “2.It is also understood as: (a) «infant»: a child under the age of twelve months; (b) «child in early childhood»: a child between the ages of one and three years; (c) «infant formula»: a food product intended for the feeding of infants in the first few months of life, capable of meeting the nutritional needs of infants alone until the introduction of adequate complementary feeding; (d) «follow-on formula»: a foodstuff intended for the feeding of infants at the time when adequate complementary feeding is introduced and constituting the main liquid element in the’framework of a progressively diversified feeding of such infants; (e) «cereal-based food»: a food product: plain cereal reconstituted or to be reconstituted with milk or other appropriate nutritive liquid, cereal with the’addition of a protein-rich food, reconstituted or to be reconstituted with water or other protein-free liquid, pastina to be used after cooking in boiling water or other suitable liquids, cookies and rusks to be used as such or after being crumbled and combined with water, milk or other suitable liquids; (f) «food for early childhood»: a foodstuff intended to meet the specific needs of healthy infants in the weaning period and healthy toddlers in early childhood to supplement their diet and/or to gradually accustom them to ordinary food, excluding:(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; è intended for the complete or partial feeding of patients with limited, disturbed or impaired ability to take in, digest, absorb, metabolize or eliminate common foods or certain nutrients contained therein or metabolites, or with other nutritional needs determined by clinical conditions and whose dietary management cannot be carried out solely by modification of the normal diet; h) «substitute for the’whole daily food ration for weight control»: a food product expressly formulated for use in the’context of low-calorie diets aimed at weight reduction that, when used according to the instructions of the food business operator, replaces the’entire daily food ration”.
20 Commission Regulation (EC) No. 889/2008 of September 5, 2008 laying down detailed rules for the implementation of Council Regulation (EC) No. 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control.
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 organic food processing, with the exception of wine: (a) the substances listed in Annex VIII to this Regulation; (b) preparations of microorganisms and enzymes normally used in food processing; (c) substances and products defined in Article 1(2)(b)(i) and Article 1(2)(c) of Council Directive 88/388/EEC and labeled as natural flavoring substances or natural flavor preparations in accordance with Article 9(1)(d) and Article 9(2) of the same Directive; (d) colorants used for stamping meat and eggshells 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 chloride or potassium chloride as a basic component) customarily used in food processing (f) mineral substances (including trace elements), vitamins, amino acids and other micronutrients, which are authorized only if their use è legally required in the foods in which they are incorporated.
22 Judgment C-137/13 of November 5, 2014.
23 That ruling sanctioned the prohibition of certifying as organic foods governed by dir. 2009 / 39 / EC and Reg. 953 / 2009 if they are supplemented by vitamins and mineral salts
24 Article 1(1)(a) of Regulation 609/2013.
25 Article 1(1)(b) of Regulation 609/2013.
26 It should be recalled that prior to the entry into force of Regulation 609/2013, some European states considered growing milks to be covered by dir. 2009/39/EC on foods for particular nutritional uses (i.e., dietetic products). In fact, that directive did not contain a positive listing of what were dietetic foods, consequently the interpretation was left to individual member states. Now, however, with the new wording of’Article 2(2)(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) «early childhood food» means a foodstuff intended to meet the specific needs of healthy infants in the weaning period and healthy toddlers in early childhood to supplement their diet and/or to accustom them gradually to an ordinary diet, excluding: i) cereal-based foods; and ii) milk-based beverages and similar products intended for infants in early childhood;”
28 DG PQAI - PQAI 01 - Exit Prot. No.0053423 dated 19/07/2018.
29 This 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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