Assessment of the Impact of Scientific Reports Published by EFSA and GIS on Functional Foods Newly Placed on the Market in Poland

Dietary supplements are health-promoting products. The legal categorization of dietary supplements as foods does not raise concerns, but a general understanding of how they work in the human body seems to deviate from the official definition. Thus, it is necessary to establish effective methods of market control related to dietary supplements. This research aims at assessing the impact of recommendations by various food safety authorities on ingredients used in newly registered products. It probes how the proportions of utilized product ingredients were modified after the European Food Safety Authority (EFSA) and Chief Sanitary Inspector in Poland (GIS) published their recommendations. Research data on the composition of products comes from the Polish national register of dietary supplements and covers the period from 2012 to 28 November 2021. Note that 103,102 products were analysed for the presence of thirty-seven ingredients, and the joinpoint regression method was applied to assess changing trends related to the use of ingredients. As our research points out, most often, changes in the trend appeared in product ingredients for which the European Food Safety Authority and Chief Sanitary Inspector in Poland issued the recommendation of having the safest level of consumption. However, these changes seem to emerge randomly and should not be unquestionably considered as the result of the published recommendations.


Introduction
Dietary supplements (DS) are included in the group of healthy products and, as foods they are supervised by the state sanitary inspection bodies. The decision to consume DS is often initiated by the consumers themselves, and it may be opposed [1]. Their legal status and social perception present various challenges in the areas of their effectiveness, safety, regulations, and clinical approach [2].
No uniform and standardized method of supervision over healthy products already placed on the market exists in the Member States of the European Union. For this reason, it is necessary to search for effective methods of market control [3,4]. This is especially important in terms of the emerging awareness concerning the adverse effects experienced by consumers of dietary supplements [5][6][7].
Although the legal categorization of dietary supplements as foods does not raise concerns, the consumers'-or rather, the patients'-understanding of their function seems to stray far from the official definition [8]. This is important since certain ingredients in dietary supplements can hardly be recognised as components of a normal diet, which supplements are intended to enhance. For instance, red yeast rice is one such ingredient that 2 of 56 is promoted as a cholesterol-lowering remedy [9]. The perception of dietary supplements as being medical products rather than food formulations is demonstrated by the extended statutory definition published in 2006, which contains a provision that excludes from this group all products that have medicinal properties in accordance with the meaning of the pharmaceutical law [10]. This fact may point to the growing interpenetration of the pharmaceutical and the food markets, including dietary supplements. The forms of supplements include capsules, tablets, or lozenges, and evoke obvious associations with medicinal products, while the regulatory changes only emphasise the link between the two markets.
In order to ensure effective monitoring associated with the safety of dietary supplements, all member states of the European Union can introduce registration models and requirements for products placed on the market. This solution is stipulated in Article 10 of Directive 2002/46/WE of the European Parliament and of the Council of 10 June 2002. on the approximation of the laws of the EU member states regarding food supplements. The directive allows the administrative bodies responsible for ensuring the safety of consumers in individual countries to require companies to inform them about placing dietary supplements on the market by submitting a template of the product's label [11].
Despite the optional character of Art. 10 of the directive, most member states follow and set up monitoring systems/models for dietary supplements placed on the market. These systems can vary and possess different degrees of impact on the freedom to launch new products [3].
In the EU countries, it is possible to recognise four monitoring systems for dietary supplements on the market. They are characterised by various degrees of freedom related to implementing new products. The first and smallest group of EU member states includes countries that did not decide to introduce any notification system. Thus, entrepreneurs have the possibility to place healthy foods on the market freely, but they must meet the general and specific requirements of food laws. Obeying the law is verified during frequent official controls of food products [12][13][14][15][16][17][18]. However, the second, most popular, solution is a notification system that obliges food business operators to notify the food authorities of their intention to launch the sale associated with a particular dietary supplement. Nonetheless, approval or authorization by the institution in question is not required [19][20][21][22][23][24][25][26]. This system of notification on placing new healthy food products on the market also exists in Poland [27]. Note that selected EU states enlarge the above system or model by creating an additional obligation of paying administrative fees [28][29][30][31][32][33][34][35][36][37]. Moreover, a group of European markets can be further specified by requiring that new supplements and healthy food products are authorised by regulatory organizations, which review a formal application seeking approval to the market free of charge [38], as well as for a fee [39]. A detailed overview of the models of registration and authorization of healthy products is presented in the Table 1 below.
Let us emphasise the unique character of the solution implemented in Poland. The adopted system is one of four out of a total of 28 analysed, which presupposes public availability of the register together with the full qualitative list of ingredients used in the respective products.
It is also worth mentioning that, despite the statistical reporting carried out for dietary supplements in the area of the value of marketed production-unlike in the case of other typical food products-it is impossible to obtain reliable data on the volume and value of production and sale. This may be caused by the lack of a separate group, both according to the Combined Nomenclature (CN) and the Polish Classification of Goods and Services [40]. This means that the discussed register of products is the sole official source containing information on healthy products placed on the market in Poland.
The aim of this research is to assess the impact of recommendations published by food safety authorities in Poland and the European Union linked to the quality and maximum safe levels of ingredients found in dietary supplements and other healthy food products newly registered in Poland.

Materials and Methods
In the context of the model of monitoring of products placed on the market presented above, attention should be paid to state administration institutions and bodies whose task it is to shape the scientific basis for the supervision of the safety of dietary supplements. Numerous official and non-governmental structures exist that are engaged in the process of risk assessment of using specific ingredients of healthy foods; this study, however, focuses on two of them, with an attempt to identify changes that occurred in the register of healthy products in the area of ingredients that are the subject of scientific recommendations.

EFSA
European Food Safety Authority (EFSA) is an agency financed by the European Union which operates independently from European legislative and executive bodies such as the Commission, the Council, or the Parliament, as well as the Member States. The office was set up in 2002 in response to the series of food crises that occurred towards the end of the 1990s. At that time, the agency was to be a scientific body and a source of information concerning the threats connected to the food chain. The agency was legally established by the European Union on the basis of general food law, i.e., Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety. In most cases, EFSA undertakes actions that respond to applications for scientific advice submitted by the European Commission, the European Parliament, or the Member States. The agency also carries out scientific research undertaken on its own initiative. This takes place particularly in situations when new problems and threats in the food chain arise, as well as in order to update the existing methods of assessment of known risks.
Scientific activities performed as part of the activities of EFSA are mainly carried out within the framework of scientific panels and committees. Members of these structures are appointed through open competitions. EFSA may also issue assessments and opinions prepared by its own staff members. EFSA employees monitor and analyse information and data concerning biological threats, chemical impurities, food consumption, and emerging threats [41,42]. Safety of astaxanthin for its use as a novel food in food supplements (published 5 February 2020) The above opinion updates the recommendations concerning astaxanthin intake norms. Considering the updated assessment of exposure to astaxanthin in the basic diet (fish and crustaceans) coupled with the 8 mg from dietary supplements, the NDA panel concluded the following: (i) such total exposure to astaxanthin is safe for adults, (ii) adolescents from 14 to <18 years reach the ADI, and (iii) the ADI exceeds 28% in children aged 10 to <14 years and up to 524% in infants aged 4-6 months [51].
The publication date criterion was the main one that determined whether an opinion was qualified for the study. Only opinions issued in the years 2012-2020 that pertained to substances used as ingredients in dietary supplements were included (opinions concerning additives, novel foods (pursuant to regulation 2015/2283, extended uses opinions and chemical/synthetic compounds), as well as enzymes, and opinions concerning materials and products for contact with food were excluded).

GIS
The system of food safety supervision in Poland covers the whole food chain, in accordance with the "from field to fork" principle. The resort responsible for compliance with the regulations in the area of food of non-animal origin is the Ministry of Health, while animal products available on the market are the formal responsibility of the Ministry of Agriculture and Rural Development. The most important governmental bodies that control food safety are the Chief Sanitary Inspectorate (GIS) and the General Veterinary Inspectorate. Both these inspectorates operate on the basis of regulations specifying their competences; however, the large majority of tasks connected with supervision over the production and distribution of dietary supplements and other healthy food products remain the responsibility of GIS [ The Team's tasks include, e.g., content-related and scientific support for the Chief Sanitary Inspector. The range of responsibilities in this respect primarily involves matters related to products covered by the notification obligation, specified in Art. 30 Item 1 of the Act on Food and Nutrition Safety. The effect of the Team's work is written opinions in the form of resolutions, compiled lists of plant ingredients with their maximum doses in dietary supplements, as well as the norms that determine the maximum doses of vitamins and other mineral ingredients in the recommended daily portions of dietary supplements, exceeding which they exhibit medicinal properties. In addition, the Team is responsible for the monitoring of interactions and adverse effects of dietary supplements [54,55].

Resolutions of the Team for Dietary Supplements
In the analysed period, the Team published 37 resolutions, which pertained to a total of 43 ingredients used in products that are subject to the obligation of notification. In order to assess their impact, resolutions issued before the year 2021 were considered. These pertained to 28 ingredients, i.e., aloe, ashwagandha, beta-alanine, boron, chromium, zinc, fluorine, phosphorus, isoflavones, iodine, caffeine, folic acid, pantothenic acid, magnesium, manganese, copper, white mulberry, niacin, vitamin A, vitamin B1, vitamin B12, vitamin B2, vitamin B6, vitamin C, vitamin D, vitamin E, vitamin K, and iron. A detailed list of all the selected resolutions, including their prevalence and publication dates, is presented in Table A1. A total of 132,906 notifications were qualified for the first phase of the study. After excluding the notifications made in the years 2007-2011, 121,867 notifications were included in further analysis. Close to 25% of this number (24.46%) are notifications made by a single entity "X", active in the years 2018-2021. Notifications made by company "X" in subsequent years were the following: 9% of all the notifications in 2018; 23% in 2019; in the year 2020 the proportion was 57%, while in 2021 (up to and including 28 November), the notifications made by entity "X" comprised 50% of all the notifications. It should be emphasised that the discussed company offers the so-called personalised supplementation. What this means in practise is that each modification to the formula performed by a given customer requires a new, repeated registration of the product. Such a model of distribution translates to a large number of notifications, which-unlike in the case of the typical model-may not correlate with the prevalence of a given product on the market. In the most radical version, one notification may denote only one product physically placed on the market. Due to the aforementioned high numbers of notifications made by entity "X", it was excluded from further study. Ultimately, 103,102 notifications were included in the analysis.
The character of individual scientific opinions and resolutions may be differentiated according to their intended function. The analysed documents included the following opinions: (i) those determining the maximum dose of vitamins or minerals; (ii) those determining additional qualitative requirements concerning the ingredients subject to the opinion; (iii) those confirming the safety of use in food products; (iv) those indicating an action that is characteristic for medicinal products or even toxicity.

Data Analysis
An analysis of the products from the register in terms of the presence of particular ingredients was carried out with the use of the Text Miner function in Statistica 13.1 software (StatSoft). Text mining is a method that enables you to extract structured data from unstructured or partially structured sources such as text databases [56]. Considering the ingredients that may customarily appear in the register under various names, their synonyms were also included, i.e., thiamine and vitamin B1. All items from the register (each notification) were analysed using Text Miner function in terms of the presence or absence of each of the analysed ingredient. The result of the analysis was coded in the 0-1 system; where 0 denoted absence of the ingredient, while 1-its presence. Occurrences of the respective ingredients were summed up into quarters.
Joinpoint regression software (Version 4.9.0.0. March 2021) was used for calculations and graphic presentation. The joinpoint regression programme is a statistical solution that enables to test whether an apparent change in trend is statistically significant. This method consists of fitting several linear (or log-linear) segments to data, connecting in joinpoints where a change in the trend occurs [57].
The joinpoint regression programme was used to fit weighted least-squares regression models to the percentage of the presence of the ingredient on the logarithmic scale. It was assumed that the error random variable in the model was homoscedastic. For a joinpoint software run, a minimum of two observed time points in the beginning and ending line segments (including the joinpoint) and a minimum of two observed timepoints in any middle line segment (including the two joinpoints) were allowed. A minimum of zero and a maximum of five joinpoints were searched for using the Grid search algorithm, the permutation test, and an overall alpha level of 0.05. QPC is quarter percent change, which shows the rate of change in the presence of the ingredient over time. When interpreting this parameter, it is said that the presence of the ingredient changes each quarter by a fixed percentage [58].

Results
Depending on the results of the performed analysis, the ingredients were divided into the following four groups. The proportion of all the ingredients in the group increases throughout the whole analysed period (Figure 1). This increase is statistically significant in the case of ashwagandha (QPC = 7.50) and astaxanthin (QPC = 2.09). No joinpoints can be observed after scientific opinions concerning the ingredients in question have been published. a maximum of five joinpoints were searched for using the Grid search algorithm, the permutation test, and an overall alpha level of 0.05. QPC is quarter percent change, which shows the rate of change in the presence of the ingredient over time. When interpreting this parameter, it is said that the presence of the ingredient changes each quarter by a fixed percentage [58].

Results
Depending on the results of the performed analysis, the ingredients were divided into the following four groups.

No Joinpoints Identified
3.1.1. Upward Trend: Ashwagandha, Astaxanthin, Lactoferrin, Lycopene, Trans-Resveratrol, White Mulberry The proportion of all the ingredients in the group increases throughout the whole analysed period (Figure 1). This increase is statistically significant in the case of ashwagandha (QPC = 7.50) and astaxanthin (QPC = 2.09). No joinpoints can be observed after scientific opinions concerning the ingredients in question have been published.

Upward-Downward Trend: Boron
Using boron in newly registered healthy products in the time from the beginning of the analysed period to the second quarter of 2021 increased significantly (QPC = 2.32), while after this period a strong downward trend (QPC = −71.96) (Figure 3) occurred. The resolution that determines the maximum doses of boron in dietary supplements was published in the first quarter of 2020, so the change occurred five quarters after the quantitative norms of use were established.    the given raw material and, later, in relation to the identified joinpoints. An exception is isoflavones, in which case the resolution was published in the first quarter of 2019. A year later, the beginning of an upward trend in the use of isoflavones can be observed. Five out of the 11 ingredients whose use in new products significantly decreased showed the following statistically significant increases of use: iodine, QPC = 2.20; iron, QPC = 1.09; vitamin A, QPC = 1.84; vitamin C, QPC = 1.56; vitamin E, QPC = 1.06.    The use of pantothenic acid in the whole analysed period was decr with a statistically significant decrease occurring in the time from the fir up until the end of the analysed period, i.e., until the fourth quarter of 20 The resolution concerning pantothenic acid was published in the fourth during the period of a constant decrease in the use of the ingredient.  The use of folic acid and zinc significantly decreased in the period from the beginning of the study until the first quarter of 2018 (folic acid, QPC = −1.72; zinc, QPC = −1.33). Then, the use of both these ingredients significantly increased-for zinc, until the third quarter of 2020 (QPC = 5.87), while for folic acid, until the fourth quarter of 2020 (QPC = 3.26). Resolutions concerning the maximum levels of both these ingredients were published in the second quarter of 2019, i.e., approximately halfway through the period of increase (6 quarters after the occurrence of the joinpoint and 5/6 quarters before the end of the upward trend). In subsequent quarters, downward trends in the use of the discussed ingredients can be observed ( Figure 6). The trends for manganese use are slightly different; its use was decreasing significantly from the third quarter of 2015 (QPC = −3.79), then it was increasing significantly for 21 quarters, until the end of 2020 (QPC = 2.31). At six quarters before the upward trend stopped (the second quarter of 2019), a resolution was published that determined the maximum levels of manganese in dietary supplements ( Figure 6). Then, a statistically significant decrease in the use of the ingredient can be observed (QPC = −14.07).

Downward-Upward-Downward Trend: Folic Acid, Manganese, Zinc
The use of folic acid and zinc significantly decreased in the period from the beginning of the study until the first quarter of 2018 (folic acid, QPC = −1.72; zinc, QPC = −1.33). Then, the use of both these ingredients significantly increased-for zinc, until the third quarter of 2020 (QPC = 5.87), while for folic acid, until the fourth quarter of 2020 (QPC = 3.26). Resolutions concerning the maximum levels of both these ingredients were published in the second quarter of 2019, i.e., approximately halfway through the period of increase (6 quarters after the occurrence of the joinpoint and 5/6 quarters before the end of the upward trend). In subsequent quarters, downward trends in the use of the discussed ingredients can be observed ( Figure 6). The trends for manganese use are slightly different; its use was decreasing significantly from the third quarter of 2015 (QPC = −3.79), then it was increasing significantly for 21 quarters, until the end of 2020 (QPC = 2.31). At six quarters before the upward trend stopped (the second quarter of 2019), a resolution was published that determined the maximum levels of manganese in dietary supplements ( Figure 6). Then, a statistically significant decrease in the use of the ingredient can be observed (QPC = −14.07).

Downward-Downward Trend: Cranberry Derivatives
The use of cranberry preparations decreased throughout the whole analysed period (Figure 7). In the time from the beginning of the analysed period until the end of 2019, the decrease was statistically significant and characterised by slow dynamics (QPC = −2.00). In the period from the fourth quarter of 2019 to the third quarter of 2020, a sudden and statistically significant decrease in the use of cranberry derivatives was observed, while in the subsequent quarters only occasional cases of the use of this type of raw material occurred.
The scientific opinion concerning this ingredient was published in the second quarter of 2017, i.e., 13 quarters before the sudden drop in its use.

Downward-Downward Trend: Cranberry Derivatives
The use of cranberry preparations decreased throughout the whole analysed period (Figure 7). In the time from the beginning of the analysed period until the end of 2019, the decrease was statistically significant and characterised by slow dynamics (QPC = −2.00). In the period from the fourth quarter of 2019 to the third quarter of 2020, a sudden and statistically significant decrease in the use of cranberry derivatives was observed, while in the subsequent quarters only occasional cases of the use of this type of raw material occurred.
(a) (   Figure 6. A schematic graph of the frequency of the period from the first quarter of 2012 to the fo of publication of a scientific opinion or a resoluti ment of the symbol reflects the level of use of the ganese ( Figure A31); (c): Zinc ( Figure A32).

Downward-Downward Trend: Cranbe
The use of cranberry preparations decr (Figure 7). In the time from the beginning of decrease was statistically significant and ch In the period from the fourth quarter of 201 statistically significant decrease in the use o in the subsequent quarters only occasional occurred.
The scientific opinion concerning this in of 2017, i.e., 13 quarters before the sudden d  The scientific opinion concerning this ingredient was published in the second quarter of 2017, i.e., 13 quarters before the sudden drop in its use.

Downward-Upward-Upward Trend: Vitamin K
Throughout the analysed period, the trends of use of vitamin K were changing, with a significant decrease occurring in the period from the beginning of the analysed period until the second quarter of 2013 (QPC = −15.21), then increasing. The period when the increase takes place is divided into two phases (Figure 8). The first one lasts from the second quarter of 2013 until the first quarter of 2015, when the increase is dynamic (QPC = 14.66); the second one lasts until the end of the analysed period, with a smooth but statistically significant increase, for which the QPC value was 1.85. The resolution concerning vitamin K was published in the first quarter of 2020.
Throughout the analysed period, the tr a significant decrease occurring in the perio until the second quarter of 2013 (QPC = −1 increase takes place is divided into two phas ond quarter of 2013 until the first quarter o 14.66); the second one lasts until the end of t tically significant increase, for which the QP vitamin K was published in the first quarter The use of yohimbine in new healthy p the analysed period until the second quarter period, an EFSA scientific opinion was publ after the upwards trend stopped, a statistical of cranberry preparations can be noted (QPC The use of yohimbine in new healthy products was increas the analysed period until the second quarter of 2015. Approxima period, an EFSA scientific opinion was published (third quarter after the upwards trend stopped, a statistically significant decrea of cranberry preparations can be noted (QPC = −15.57), which la ters. After this period, a dynamic, albeit short-lasting, 3-month ingredient is visible, after which a statistically significant decre quarter of 2019 until the end of the analysed period (QPC = −15. Beta-alanine is characterised by a distribution of popular From the beginning of the analysed period, the use of this ingre nificantly (QPC = 4.23) up to and including the third quarter of icant decrease was noted (QPC = −7.55) which lasted another 1 from the second quarter of 2018, an upward trend can be obser quarter of 2019. In the same quarter, a resolution was published t of use of beta-alanine in dietary supplements. From that momen alysed period, a statistically significant decrease of use was obse  The use of yohimbine in new healthy products was increasing from the beginning of the analysed period until the second quarter of 2015. Approximately halfway through this period, an EFSA scientific opinion was published (third quarter of 2013). 7 quarters later, after the upwards trend stopped, a statistically significant decrease of the frequency of use of cranberry preparations can be noted (QPC = −15.57), which lasted for a further 12 quarters. After this period, a dynamic, albeit short-lasting, 3-month increase in the use of the ingredient is visible, after which a statistically significant decrease occurs, from the first quarter of 2019 until the end of the analysed period (QPC = −15.02).
Beta-alanine is characterised by a distribution of popularity similar to yohimbine. From the beginning of the analysed period, the use of this ingredient was increasing significantly (QPC = 4.23) up to and including the third quarter of 2015, after which a significant decrease was noted (QPC = −7.55) which lasted another 11 quarters. In the period from the second quarter of 2018, an upward trend can be observed lasting until the first quarter of 2019. In the same quarter, a resolution was published that established the norms of use of beta-alanine in dietary supplements. From that moment until the end of the analysed period, a statistically significant decrease of use was observed (QPC = −4.39).

Discussion
As far as the assessment of the impact ularity of the used ingredients (that are the cerned, it seems that both these areas (scient ally independent. The ingredients, with sig

Discussion
As far as the assessment of the impact of the selected scientific opinions on the popularity of the used ingredients (that are their subjects) in new healthy products is concerned, it seems that both these areas (scientific opinions and used ingredients) are mutually independent. The ingredients, with significantly changed usage records in the analysed period, had joinpoints occurring at the following various times: from the same quarters in which the scientific opinions were issued, through three quarters after the opinion, to joinpoints occurring several quarters later after the publication. Considering the character of the published recommendations, it was observed that in the largest number of cases (28) are the scientific opinions and resolutions determined the maximum doses permitted in dietary supplements. This group included as many as 18 ingredients, in which a history of using a joinpoint was identified. Note that in eight cases, the joinpoint occurred earlier than 10 quarters after the announcement recommendation (including four cases with a joinpoint occurring up to five quarters after the recommendation and four cases with a joinpoint in the period from the fifth to the tenth quarter). In all the above-mentioned situations, except for isoflavones, a visible decrease in the trend took place in the joinpoint that occurred after the publication of the resolution determining the maximum permitted doses.
In turn, among the five published recommendations establishing additional qualitative requirements linked to the ingredients, three of them also determined their maximum doses. In this group, only two ingredients had joinpoints in their analysed history of use, but only one of them occurred more than 10 quarters later after the scientific opinion was published. It was related to cranberry derivatives.
Regarding the scientific opinions confirming the safety of using specific ingredients in food products and healthy foods, it was observed that four out of six cases in this group were characterised by an upward trend of use, and two cases had a downward trend. Interestingly, in the case of three scientific opinions questioning the safety of having certain ingredients, two ingredients were characterised by a consistently decreasing trend of use, while one, related to yohimbine derivatives, changed the trend from upward to downward in a period of time shorter than 10 quarters from the moment the opinion was published.
In the case of three ingredients (boron, isoflavones, and cranberry derivatives), the published recommendation resulted in an increase in the use of the ingredient. After the scientific opinion was published, the average time of the occurrence of a joinpoint appeared to be slightly longer than 5 quarters. At the same time, after an EFSA scientific opinion was published, which stressed that it is impossible to determine a safe level of yohimbine in foods, a decrease in the use of this ingredient can be observed, excluding a short period of growth from 2018 to 2019.
Furthermore, beta-alanine and vitamin D (the second resolution) present singular cases in which the publication of a GIS resolution and the decrease in the use of the ingredient occurred within a single quarter.
Looking at the other ingredients that possessed changeable trends of use in new products during the analysed period of time and had a single joinpoint occurred, it is possible to recognise that resolutions were published only after the joinpoint occurred. This situation seemed to take place during the upward trend. Nevertheless, in the case of pantothenic acid, it exceptionally happened during the downward trend. On average, the above occurred 14 quarters from the moment of trend change as follows: the fastest (shorter than 10 quarters) was in the case of vitamin C, vitamin B6, and fluorine. A similar course of action related to the publication of GIS resolutions was also observed in the cases of folic acid, zinc, and manganese. Resolutions establishing the maximum levels of use of the other vitamins and minerals covered by this study were published more than 10 quarters after the beginning of the upward trend.
To interpret the obtained results comprehensively, several factors should be taken into consideration. First of all, it is difficult to conclusively determine what time, after a recommendation is issued, should be considered the beginning of a trend change. Limited literature data on this topic describes extreme behaviour exhibited by some food industry companies in response to the need to adhere to sector recommendations. For instance, literature points out cases when a significant reduction in the calorie content of drinks delivered to schools was achieved within a two-year period since the publication of a sector manual [59], but at the same time, it accentuates other cases in which, despite declarations made by the producers concerning adequate product marketing aimed at children, only slightly over 10% of the assessed products complied with the criteria specified by the WHO [60]. Moreover, as the case of titanium dioxide shows, which safety in food products cannot be confirmed [61], the time from the moment the scientific opinion is issued [62] until the eventual date of its withdrawal from the food market can be as long as five quarters [63].
The amount of time needed to produce a dietary supplement should also be taken into consideration as it largely depends on the availability of ingredients. In extreme cases, the availability of certain ingredients may depend on transport from Asia and may take several months [64]. This situation especially applies to derivatives of plant-based ingredients native to such regions. This includes the following: derivatives of reed yeast rice, ECGC, ashwagandha, and white mulberry [65]. In all the cases mentioned, official recommendations dictated additional quality requirements. Thus, even the precise adjustment of ingredient levels may not be sufficient to fulfil standards set by the recommendation. In some cases, the ingredients should be changed. This necessity may result in a prolonged time of market adaptation to the new norms. However, adaptation marketing strategies seem to be underestimated by officially published recommendations.
When examining changes in the use of cranberry derivatives, it should be stated that a certain limitation of the analysis was caused by linguistics. For instance, this insufficiency was visible in the area of identification of products containing cranberry derivatives. It should be emphasised that the EFSA recommendation concerning the above ingredient mainly pointed out "cranberry extract powder". However, after considering specific characteristics of Polish grammar, all items in the register that contained the term "cranberry" (cranberry in the genitive case) were qualified for the study. This may mean that products that did not contain "cranberry extract powder" but also, for example, "cranberry juice" or "cranberry fruit" were also analysed. The modification of the method of registration of healthy products introduced in February 2020 should also be mentioned here. This change consisted of blocking the subjects that make the notification from freely entering the names of ingredients; instead, they were to be selected from a drop-down list. Despite the fact that the possibility of using "cranberry extract powder" is a direct result of the specific provisions of the food law in force in the European Union (the so-called novel food list), this particular ingredient is not available on the selection list. The effect of this is the absence in the register of products that include "cranberry" in the genitive in their list of ingredients since February 2020. The registering entity may choose from the list "cranberry" in the nominative only. Due to this state of affairs and the technical limitations, all the conclusions concerning the impact of the EFSA opinion on the placement of products containing "cranberry extract powder" on the market should be qualified as uncertain.
The phenomenon of the increase in the use of a given ingredient after the publication of a scientific opinion also requires a critical assessment. In this context, the aspect of the placement of unsold stock on the market-after the scientific or legal realities have changed-cannot be omitted. One of the phenomena observed after limitations in the area of the maximum upper doses of certain minerals and vitamins have been published is the change in labelling of the product in the area of the recommended daily intake. In practise, the determination of the maximum level of vitamin D in a daily dose of a dietary supplement at 2000 I.U. may lead to the appearance of products on the market that would recommend the consumption of a tablet. An example that illustrates this phenomenon very well is a dietary supplement containing 4000 I.U. of vitamin D in a single tablet, which is then registered again after new requirements in the area are introduced but with a dose of tablet, so that it would meet the norms of supply of the ingredient in question. Market practises of this kind may result in an increase in the total number of new notifications for registration. This may explain the constant upward trends in the use of certain ingredients.
On the other hand, it would also be risky to conclude that the response time of opinionforming bodies to a theoretically increasing use of a given ingredient is related to its safety for consumers. For example, vitamin C belongs to the group of vitamins with a low risk of exceeding the upper level (UL), whereas manganese and copper belong to the group with a relatively high risk of overdose [66]. Despite this, the resolutions that regulate the use of the two latter minerals appeared later (in relation to the beginning of the upward trend) than in the case of vitamin C. This leads to the side conclusion that categorization or any other attempt at ordering the ingredients according to a criterion based on the date of publication of the opinion/resolution would be unjustified in the light of the analysed data.
The matter of the increasing supply of certain groups of ingredients is also not without significance. The authors' own research shows that the increasing trends in the use of, e.g., zinc, vitamin C, and vitamin D correlated with the subsequent waves of the COVID pandemics [67]. The presence of this type of seasonal increase in popularity and demand for selected healthy products may make it difficult to observe the real impact of an opinion on the producers' responses to the changes they imply.
It is important to note that the European Commission, on a request made by the Directorate-General for Health and Food Safety (DG SANTE), has undertaken the initiative to determine the maximum levels of vitamins and minerals added to food and dietary supplements in the form of a future regulatory resolution. In this area, public consultation in this area is planned during the second quarter of 2023, and the approximate time for accepting this regulation by the Commission is envisioned as the first quarter of 2024.

Conclusions
As a result of the analyses, the following relationships were formulated: 1.
In most cases, publications of EFSA's scientific opinions and GIS resolutions do not significantly change the trends of popularity or use of the ingredients that are the subject of the recommendations in newly registered products; 2.
Changes in trends, understood as joinpoints, appearing chronologically after the publication of a scientific opinion/resolution, seem too removed in time to conclude, on the basis of the collected data, which they are the direct result of GIS and EFSA actions. It can be assumed that those recommendations that determine the maximum permitted levels of ingredients have potentially the strongest impact on the behaviour of producers; 3.
Further studies are required to assess changes in the levels of particular ingredients. In addition, they may identify potential practises aimed at bypassing a set of norms established by opinion-forming bodies. In order to determine the safest/highest levels of vitamins and minerals in dietary products, this aspect is particularly important as it allows for the creation of proper food regulations; 4.
A public register of dietary supplements may be an effective tool to support the non-official control of the market known as its self-control. However, any register of supplements can perform its function if and only if there is research, including data on doses of active ingredients in dietary products.

Institutional Review Board Statement: Not applicable.
Informed Consent Statement: Not applicable.

Conflicts of Interest:
The authors declare no conflict of interest.
Appendix A Table A1. Quality requirements and maximum levels of vitamins, minerals, plant ingredients and other ingredients with a physiological effect in dietary supplements.

Ingredient Maximum Levels and Other Requirements Resolution Number (Date)
Vitamin A 800 g of retinol equivalent (retinol and retinyl esters); 7 mg of β-carotene.

Ingredient Maximum Levels and Other Requirements Resolution Number (Date)
White mulberry (Morus alba L.) The maximum content of 1-deoxynojirmycin (DNJ)-at the level of 10 mg in the recommended daily portion of the product; An entity placing a given food on the market should have information on the content of DNJ, per the recommended daily portion of the product.